US WorldMeds Announces FDA Approval of IWILFIN™ (eflornithine) to Strengthen Fight Against Aggressive Childhood Cancer

First and only FDA-approved oral maintenance therapy for high-risk neuroblastoma

LOUISVILLE, Ky. (December 14, 2023) – USWM, LLC (US WorldMeds) today announced that the U.S. Food and Drug Administration (FDA) has approved IWILFIN™ (eflornithine) 192 mg tablets, a groundbreaking oral maintenance therapy for high-risk neuroblastoma. IWILFIN is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy.

According to the American Cancer Society, 700-800 cases of neuroblastoma are diagnosed in the U.S. each year, with 90% of diagnoses coming before age 5. Over 50% of these cases are classified as high-risk. High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission. Approximately half of children with high-risk neuroblastoma do not survive beyond five years from diagnosis. Although existing treatments are effective in helping patients achieve remission, patients lack options to sustain it. Avoiding relapse is crucial to improving survival rates.

“We are thrilled to announce the FDA approval of IWILFIN, which provides a new and much- needed treatment option for children with high-risk neuroblastoma,” said Breck Jones, Chief Executive Officer of US WorldMeds. “The goal for treating these young patients is to prevent relapse, and advancing therapeutic options is critical to this mission. IWILFIN offers new hope and improved outcomes for these vulnerable children.”

The approval of IWILFIN is based on the results of a multi-site, single-arm, externally controlled study of children with high-risk neuroblastoma who received IWILFIN as maintenance therapy following standard of care treatment, including immunotherapy. The study demonstrated that the addition of IWILFIN improved event-free survival (EFS) and overall survival (OS) in patients with high-risk neuroblastoma. At four years following immunotherapy, EFS in the IWILFIN- treated patient group was 84% compared to 73% of patients in the external control group, and 96% of patients treated with IWILFIN were alive compared to 84% of external control patients. This corresponded to a 52% reduction in the risk of relapse and a 68% reduction in the risk of death. Across additional analyses to confirm the results of the externally controlled study design, the relapse risk reduction ranged from 57% to 41% and death risk reduction ranged from 71% to 55%.

IWILFIN is taken orally, with or without food, twice daily for two years. IWILFIN is generally well-tolerated, with side effects typically manageable through dose modifications. The most common side effects are hearing loss, otitis media, pyrexia, pneumonia, and diarrhea. Important Safety Information can be found below.

US WorldMeds partnered with the Beat Childhood Cancer Research Consortium at Penn State University, which conducted the preclinical and clinical research to help advance this vital therapy. The Consortium represents a group of over 50 hospitals that offer collaboration through a network of childhood cancer clinical trials.

“Our partnerships were instrumental in bringing IWILFIN through the FDA registration process,” said Kristen Gullo, Vice President of Development and Regulatory Affairs at US WorldMeds. “We are thankful for the dedication of our partners, specifically the Beat Childhood Cancer Research Consortium, who work tirelessly to improve treatment outcomes for pediatric cancer patients. This FDA approval represents a beacon of hope for the high-risk neuroblastoma community and a significant step forward in the fight against this devastating disease.”

“After diligent efforts for the past decade, I am both humbled and overjoyed to see this product that holds the potential to evolve the standard of care for high-risk neuroblastoma come to fruition,” said Giselle Saulnier Sholler, MD, Chair and Founder, Beat Childhood Cancer Research Consortium and Division Chief of Pediatric Hematology and Oncology at Penn State Health Children’s Hospital. “I extend my deepest gratitude to every individual and institution that contributed to this extraordinary endeavor. The unwavering commitment of the sites involved and the incredible resilience of the families who entrusted us with their children's well-being have been the driving forces behind this milestone. Their commitment has not only propelled us forward in our mission but has also paved the way for a brighter future for children facing the challenges of cancer.”

IWILFIN will be available to patients in the United States in the coming weeks. To learn more about IWILFIN, visit www.iwilfin.com.

Important Safety Information for IWILFIN (eflornithine) tablets
Before you take IWILFIN, tell your healthcare provider about your medical conditions, including if you have hearing problems, if you are pregnant or may become pregnant, or if you are breastfeeding.

If you or your partner are able to become pregnant, use effective birth control during treatment with IWILFIN and for one week after the last dose. Tell your healthcare provider right away if you or your partner become pregnant during treatment. Do not breastfeed during treatment with IWILFIN and for one week after the last dose.

IWILFIN can cause low blood cell counts. Tell your healthcare provider right away if you develop symptoms of low blood cell counts, including fever, easy bruising or bleeding, blood in your urine or stool, feeling unusually tired or weak, shortness of breath, or chills or shivering.

IWILFIN can cause liver problems. Tell your healthcare provider right away if you develop symptoms of liver problems, including your skin or white of your eyes turning yellow; dark urine; light-colored stools; nausea or vomiting; easy bruising or bleeding; loss of appetite; or pain, aching, or tenderness on the right side of your abdomen.

Hearing loss is common during treatment with IWILFIN and can be serious. Some people have needed to use hearing aids. Tell your healthcare provider right away if you get ringing in your ears or any new or worsening hearing loss.

What are the possible side effects of IWILFIN?
The most common side effects of IWILFIN include ear infection; diarrhea; cough; sinus infection; pneumonia; upper respiratory tract infection; pink eye; vomiting; stuffy, runny, itchy nose or sneezing; and fever; skin infection; and urinary tract infection.

These are not all the possible side effects of IWILFIN. Contact your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for IWILFIN here.

About US WorldMeds
US WorldMeds is a privately held specialty pharmaceutical company that develops, licenses, and markets unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs. More information on US WorldMeds can be found at www.usworldmeds.com.

IWILFIN is a trademark of USWM, LLC
US WORLDMEDS is a registered trademark of USWM, LLC
USWMIWI-00043 12/2023

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US WorldMeds and Salix Announce U.S. Launch of LUCEMYRA™ (lofexidine) 0.18 Mg Tablets

First and only FDA-approved, non-opioid medication indicated for mitigation of opioid withdrawal symptoms is now available for prescription

LOUISVILLE, Ky. and BRIDGEWATER, N.J., Aug. 6, 2018 /PRNewswire/ -- US WorldMeds, LLC, and Salix Pharmaceuticals, a wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced the U.S. launch and availability of LUCEMYRA™ (lofexidine) 0.18 mg tablets, the first and only non-opioid medication indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8314851-us-world-meds-lucemyra-fda-approval/

The Centers for Disease Control and Prevention estimates that more than 115 people in the U.S. die each day from opioid overdose.1 Often overlooked, opioid withdrawal is one of the most powerful barriers keeping people from discontinuing opioids. Many people have such difficulty tolerating symptoms of withdrawal that the desire to avoid them can perpetuate their opioid use.2 In a survey of people with chronic pain, 57 percent of patients reported avoidance of withdrawal as the primary reason for continued use of prescription opioids.3

"Many people who wish to stop taking opioids are searching for a treatment that will help get them through the agonizing symptoms of withdrawal," said P. Breckinridge Jones, chief executive officer and founder, US WorldMeds. "The availability of LUCEMYRA broadens the range of evidence-based pharmacological options available to healthcare providers, so they can manage the challenges of withdrawal and facilitate their patients' abrupt discontinuation of opioids."

The FDA approved LUCEMYRA in May 2018. The product's development involved a grant from and close collaboration with the National Institute on Drug Abuse, part of the National Institutes of Health. In June, US WorldMeds and Salix Pharmaceuticals entered into an exclusive co-promotion agreement for LUCEMYRA. Today, Salix and US WorldMeds have initiated sales force efforts in the promotion of LUCEMYRA to primary care physicians, pain management specialists, psychiatrists focused on addiction medicine and addictionologists.

"LUCEMYRA addresses a large and growing need in the field of primary care and pain management. Opioid withdrawal is frequently overlooked and can present a significant challenge in the discontinuation of opioid-based pain medications. By effectively intervening during withdrawal and helping to control severe, disabling withdrawal symptoms, LUCEMYRA can help provide a starting point toward recovery," said Mark McKenna, president, Salix Pharmaceuticals. "We share US WorldMeds' enthusiasm and confidence that LUCEMYRA can help the millions who develop Opioid Withdrawal Syndrome find meaningful relief."

The launch includes a co-pay program that provides LUCEMYRA to eligible patients for as little as $25.† Most pharmacies across the country are covered through the program.

Physicians, pharmacists or other healthcare providers with questions about LUCEMYRA should contact 1-833-LUCEMYRA or visit www.lucemyra.com.

LUCEMYRA is not an opioid drug and is not a treatment for Opioid Use Disorder (OUD) (sometimes known as opioid addiction). For people who have been diagnosed with OUD, withdrawal management alone, with or without LUCEMYRA, is not recommended; LUCEMYRA should be used as part of a comprehensive management program created by a healthcare provider.

Indications
LUCEMYRA is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.

Important Safety Information for Patients

  • LUCEMYRA will not stop you from craving opioids.
  • LUCEMYRA is not an opioid and will not produce the effects seen when taking opioids.
  • LUCEMYRA may lessen the severity of symptoms, but it may not completely prevent them.

After a period of not using opioids, you may be more sensitive to the effects of lower amounts of opioids. Taking opioids in amounts that you used before stopping opioid use, whether with or without LUCEMYRA, can lead to overdose and death. It is important that you, your family, and the people closest to you are aware of this increased risk of overdose.

Alcohol, barbiturates, and benzodiazepines should be used with caution while taking LUCEMYRA as serious side effects may occur.

Tell your healthcare provider if you have ever been diagnosed with kidney disease or liver disease.

LUCEMYRA may cause low blood pressure or slower heart rate. Tell your healthcare provider if you have ever been diagnosed with low blood pressure, slow heart rate, any other cardiac abnormality (including prior diagnosis or family history of long QT syndrome), or if you have had a heart attack.

Tell your healthcare provider about all medications you are taking. LUCEMYRA should be used with caution with any medications that decrease pulse or blood pressure.

Watch for signs of a drop in your blood pressure or heart rate, including dizziness, lightheadedness, or feelings of faintness either when sitting or if you quickly stand up. If you experience these symptoms, call your healthcare provider and do not take your next dose of LUCEMYRA until you have talked to your healthcare provider.

It is important to stay hydrated while taking LUCEMYRA during opioid discontinuation or withdrawal.

The most common side effects seen with LUCEMYRA are low blood pressure or symptoms such as lightheadedness, slow heart rate, dizziness, sleepiness, and dry mouth.

Talk to your healthcare provider before taking other medications for individual symptoms of withdrawal (such as pain relievers, sleep aids, or medications for upset stomach). Your healthcare provider will tell you whether it is safe to take LUCEMYRA with other medications you may be prescribed during opioid discontinuation (such as buprenorphine/naloxone, methadone, naltrexone).

LUCEMYRA should not be stopped abruptly. Consult your healthcare provider before stopping or reducing your LUCEMYRA dose.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-833-LUCEMYRA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here to access the full U.S. Prescribing Information and Patient Information for LUCEMYRA.

About LUCEMYRA (lofexidine)
LUCEMYRA (lofexidine), an oral tablet, is a central alpha 2-adrenergic agonist that reduces the release of norepinephrine to suppress the neurochemical surge that produces opioid withdrawal. It is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. In clinical trials, LUCEMYRA significantly reduced the severity of withdrawal symptoms compared to placebo, as reported by patients experiencing opioid withdrawal. LUCEMYRA is administered in three 0.18 mg tablets taken orally four times daily at five- to six-hour intervals during the period of peak withdrawal symptoms (generally five to seven days following last use of opioids); total treatment may continue for up to 14 days, with dosing guided by symptoms. LUCEMYRA should be discontinued with gradual dose reduction over two to four days.

About Opioid Withdrawal
Opioids lower norepinephrine, a brain chemical that supports vital functions like respiration and consciousness. With continued opioid use, the brain establishes a new equilibrium by increasing compensatory norepinephrine production in order to maintain normal functioning. When opioids are removed, or the dose is significantly reduced, the brain's increased norepinephrine levels are no longer offset by the presence of the opioids. This results in a norepinephrine surge that produces the acute and painful symptoms of withdrawal.

About US WorldMeds
US WorldMeds is a specialty pharmaceutical company whose products are making a difference in the lives of the patients and communities it serves. US WorldMeds takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US WorldMeds has global presence and more than 15 years of experience in the development, licensure, and commercialization of unique products. For more information about US WorldMeds, visit http://www.usworldmeds.com/. Follow US WorldMeds on Twitter, LinkedIn and Facebook.

About Salix
Salix is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For almost 30 years, Salix has licensed, developed, and marketed innovative products to improve patients' lives and arm healthcare providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists, and primary care. Salix is headquartered in Bridgewater, New Jersey.

About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.

Under License from Britannia Pharmaceuticals Limited.
US WorldMeds, LLC is the exclusive licensee and distributor of LUCEMYRA™ in the United States and Its Territories. ©2018. LUCEMYRA™ is a trademark of US WorldMeds, LLC. 360-10020.
The LUCEMYRA TM is licensed by US WorldMeds to Salix and its affiliates.

LUY.0085.USA.18
USWM-LUC059-0518

†Patients whose prescriptions will be paid for in part or in whole by Medicare, Medicaid or any similar federal or state healthcare program are not eligible for savings or rebates according to federal and state law. Patients must visit a participating pharmacy for savings or rebates on their LUCEMYRA prescriptions. Maximum benefits may apply.

References

  1. CDC/NCHS, National Vital Statistics System, Mortality. CDC Wonder, Atlanta, GA: US Department of Health and Human Services, CDC; 2017. https://wonder.cdc.gov.
  2. Kosten TR, George TP. The Neurobiology of Opioid Dependence: Implications for Treatment. Science & Practice Perspectives. 2002;1(1):13-20.
  3. Weiss RD. J Subst Abuse Treat. 2014 August; 47(2): 140–145. doi:10.1016/j.jsat.2014.03.004.
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US WorldMeds Announces Partnership With FEMA And Healthcare Ready During Coronavirus Pandemic

Company will donate opioid withdrawal medication LUCEMYRA® (lofexidine) to patients in need

LOUISVILLE, Ky., July 9, 2020 /PRNewswire/ -- USWM LLC dba US WorldMeds (USWM), a Kentucky-based company, has today announced their partnership with the Federal Emergency Management Agency (FEMA) and Healthcare Ready in bringing urgently needed opioid withdrawal medication to communities in need during the current coronavirus pandemic. This partnership will help address the opioid crisis in the context of COVID-19 for communities, clinics, and patients most impacted by the combination of the pandemic and the existing opioid epidemic. Lee Warren, Chief Operating Officer, stated, "US WorldMeds has been active in addressing the opioid epidemic. As we saw the fallout from this additional global crisis, we wanted to do our part to help out in underserved communities."

The COVID-19 pandemic continues to wreak havoc on life in the US as we know it; closures, staff shortages, and stay-at-home orders have greatly impacted those needing to access to the healthcare system for non-COVID reasons, including those patients prescribed opioids for chronic pain and those with or seeking treatment for Opioid Use Disorder (OUD). Patients in underserved communities are often the most affected by disaster; COVID-19 is no exception. Mounting evidence suggests the incidence of substance use is increasing during the pandemic.1

USWM received approval by the FDA in 2018 for LUCEMYRA® (lofexidine), an oral medication for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. While not a treatment for OUD, LUCEMYRA® is the only non-opioid medication approved by the FDA for treatment of opioid withdrawal symptoms*. Additionally, the American Society of Addiction Medicine recently identified LUCEMYRA® as the preferred non-opioid medication to treat opioid withdrawal symptoms in an outpatient setting2.

*LUCEMYRA will not completely prevent the symptoms of opioid withdrawal and is not a treatment for Opioid Use Disorder.

According to Bob James, PharmD, Director, Medical Affairs, "US WorldMeds recognizes that this may be a time when many patients are thrown into unplanned opioid withdrawal and need help with symptoms that can be devastating, even without the complication of quarantines and social distancing." Symptoms of opioid withdrawal, which can come on as quickly as 6 hours after stopping opioids, include aches and pains, yawning, stomach cramps, feeling sick, heart pounding, muscular tension, muscle spasms, chills, runny eyes, and insomnia.

USWM, in conjunction with FEMA and their partnership with Healthcare Ready, is making a donation of LUCEMYRA® valued at approximately $500,000 to VIP Community Services, Bronx NY, allowing appropriate patients who are facing unplanned withdrawal to have access to the medication at no charge. Federally Qualified Health Clinics such as VIP Community Services provide badly needed medical support to those suffering with substance use disorders, including opioid abuse and addiction.

According to Debbian Fletcher-Blake, FNP, CEO of VIP Community Services, "If there was a time for a donation like this, it's now. COVID has highlighted how left behind our patients have been in the pandemic with substance use disorder rates rising. Our clinic supports folks who have some challenges or are not able to accept services. Thank you for providing the resources to allow us to supply more comprehensive services. This buys some time to give them options. For us it's a win-win."

About LUCEMYRA® (lofexidine)
LUCEMYRA® (lofexidine), an oral tablet, is a central alpha 2-adrenergic agonist that reduces the release of norepinephrine to suppress the neurochemical surge that produces opioid withdrawal. It is indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. In clinical trials, LUCEMYRA® significantly reduced the severity of withdrawal symptoms compared to placebo as reported by patients experiencing opioid withdrawal. LUCEMYRA® is usually administered in three 0.18 mg tablets taken orally four times daily at five- to six-hour intervals during the period of peak withdrawal symptoms (generally five to seven days following last use of opioids); total treatment may continue for up to 14 days. LUCEMYRA® should be discontinued with gradual dose reduction over two to four days.3

Important Safety Information
LUCEMYRA® can cause serious side effects, including low blood pressure, slow heart rate, and fainting. Watch for symptoms of low blood pressure or heart rate, including dizziness, lightheadedness, or feeling faint at rest or when quickly standing up; if you experience these symptoms, call your healthcare provider right away and do not take your next dose of LUCEMYRA® until you have talked to your healthcare provider. Avoid becoming dehydrated or overheated and be careful not to stand up too suddenly from lying or sitting, as these may increase your risk of low blood pressure and fainting.

When your treatment is complete, you will need to stop taking LUCEMYRA® gradually, or your blood pressure could increase.

After a period of not using opioid drugs, you can become more sensitive to the effects of opioids if you start using them again. This may increase your risk of overdose and death.

Before taking LUCEMYRA®, tell your healthcare provider about all your medical conditions, including if you have low blood pressure, slow heart rate, any heart problems including history of heart attack or a condition called long QT syndrome, liver or kidney problems, or if you drink alcohol. Tell your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding; it is not known if LUCEMYRA® can harm your unborn baby or whether LUCEMYRA® passes into your breast milk.

Especially tell your healthcare provider if you take benzodiazepines, barbiturates, tranquilizers, or sleeping pills, as taking these with LUCEMYRA® can cause serious side effects.

The most common side effects of LUCEMYRA® include low blood pressure or symptoms of low blood pressure such as lightheadedness, slow heart rate, dizziness, sleepiness, and dry mouth.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-833-LUCEMYRA®. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Click here to see full Prescribing Information.

About Opioid Withdrawal 
Opioids lower norepinephrine, a brain chemical that supports vital functions like respiration and consciousness. With continued opioid use, the brain establishes a new equilibrium by increasing compensatory norepinephrine production in order to maintain normal functioning. When opioids are removed, or the dose significantly reduced, the brain's increased norepinephrine levels are no longer offset by the presence of the opioids. This results in a norepinephrine surge that produces the acute and painful symptoms of withdrawal.

About US WorldMeds
US WorldMeds is a specialty pharmaceutical company whose treatment options are making a difference in the lives of the patients and communities it serves. USWM takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, USWM has global presence and more than 15 years of experience in the development, licensure, and commercialization of unique products. For more information about USWM, visit http://www.usworldmeds.com/. Follow us on Twitter, LinkedIn, and on Facebook.

About Healthcare Ready 
Healthcare Ready (formerly Rx Response) helps to strengthen healthcare supply chains through collaboration with public health and private sectors by addressing pressing issues before, during, and after disasters. As the convener of industry and government, they safeguard patient health by providing solutions to critical problems and provide best practices for healthcare preparedness and response. https://healthcareready.org/

About VIP Community Services, Bronx NY
VIP Community Services offers integrated medical, behavioral health, housing, and wrap-around services to improve the health and well-being of the Bronx and surrounding communities. VIP is a NYS OASAS designated Substance Use Provider, Federally Qualified Health Center (FQHC) and Certified Community Behavioral Health Clinic (CCBHC). https://www.vipservices.org/

References:

  1. The Escalation of the Opioid Epidemic Due to COVID-19 and Resulting Lessons About Treatment Alternatives. Silva M., Kelly Z., AJMC;26(7) June 2020
  2. ASAM National Practice Guidelines for the Treatment of Opioid Use Disorder, 2020 Focused Update
  3. LUCEMYRA™ [Prescribing Information]. Louisville, KY: USWM, LLC; 2018.

Media inquiries:
[email protected] 
1-833-6676

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US WorldMeds and Adamis Pharmaceuticals Announce U.S. Launch of ZIMHI™ Naloxone Product

High-Dose Naloxone Now Available to Help Combat the Growing Epidemic of Overdose Deaths

March 31, 2022 16:14 ET | Source: Adamis Pharmaceuticals Corporation

LOUISVILLE, Ky. and SAN DIEGO, March 31, 2022 (GLOBE NEWSWIRE) -- USWM, LLC (US WorldMeds), and Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), today announced the U.S. launch and availability of ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL. ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose as emergency therapy in settings where opioids may be present.

According to the Centers for Disease Control and Prevention (CDC), drug overdoses are now the leading cause of death for Americans under age 50, with more powerful synthetic opioids, like fentanyl and its analogs, responsible for the largest number of those deaths. Approximately 85% of all opioid overdose related deaths are now caused by fentanyl, fentanyl analogs, and other synthetic opioids. Drug overdoses resulted in over 100,000 deaths in the United States during the 12-month period ending April 2021, which was a 29% increase over the prior 12-month period.

“ZIMHI represents an important new tool for caregivers and patients by combining an intuitive, compact, and simple to use intramuscular device with a high dose of naloxone. Successfully treating overdoses involving fentanyl often requires multiple doses of lower-dose or intranasal naloxone products, creating an urgent need for new tools to help combat these more powerful opioids,” said P. Breckinridge Jones, Sr., CEO of US WorldMeds.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “ZIMHI provides the highest intramuscular dose of naloxone among naloxone injection devices currently available. We are very excited to once again partner with US WorldMeds to launch ZIMHI. We believe that ZIMHI will play a pivotal role in the treatment of opioid overdose, while contributing positively to the entire community that has been impacted by the opioid epidemic.”

ZIMHI is available with discounted public interest pricing for first responders and other community health organizations, with additional information available via email to [email protected] or at zimhi.com/public-service/.

Patient accessibility is further enhanced with a co-pay program that provides ZIMHI to eligible patients for as little as $0. Most pharmacies across the country are covered through the program with savings being automatically applied.

Physicians, pharmacists or other healthcare providers with questions about ZIMHI should visit www.zimhi.com.

Indications
ZIMHI is an opioid antagonist indicated in adult and pediatric patients for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present. ZIMHI is not a substitute for emergency medical care.

Important Safety Information for Patients
Do not use ZIMHI if you are allergic to naloxone hydrochloride or any of the ingredients in ZIMHI. ZIMHI is used to temporarily reverse the effects of opioid medicines. The medicine in ZIMHI has no effect in people who are not taking opioid medicines.

Use ZIMHI right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Family members, caregivers, or other people who may have to use ZIMHI in an opioid emergency should know where ZIMHI is stored and how to give ZIMHI before an opioid emergency happens. Get emergency medical help right away after using the first dose of ZIMHI. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.

The signs and symptoms of an opioid emergency can return within several minutes after ZIMHI is given. If this happens, give additional injections using a new ZIMHI prefilled syringe every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

ZIMHI may cause serious side effects, including sudden opioid withdrawal symptoms, which may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, or increased heart rate.

Other common side effects of ZIMHI include dizziness and injection site redness. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.

These are not all of the possible side effects of ZIMHI. Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1-858-997-2400 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Naloxone
Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness. Common opioids include morphine, heroin, tramadol, oxycodone, hydrocodone and fentanyl.

About ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL
ZIMHI is a prescription medicine used in adults and children for the treatment of an opioid emergency, such as an overdose or a possible overdose with signs of breathing problems and severe sleepiness or not being able to respond. ZIMHI is to be given right away by a caregiver and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of ZIMHI, even if the person wakes up.

About US WorldMeds
US WorldMeds is a privately held specialty pharmaceutical company that develops, licenses, and markets unique healthcare products designed to improve the lives of patients with challenging conditions and unmet medical needs. US WorldMeds has built a branded product portfolio in the therapeutic areas of opioid use disorder medicine, hemophilia, and malignant hyperthermia. More information on US WorldMeds can be found at www.usworldmeds.com.

About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including allergy, opioid overdose, respiratory and inflammatory disease. The Company’s SYMJEPI® (epinephrine) Injection products are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The Company’s ZIMHI™ (naloxone) Injection product is approved for the treatment of opioid overdose. Tempol is in development for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. For additional information about Adamis Pharmaceuticals, please visit Adamis and follow us on Twitter and LinkedIn.

Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the marketplace acceptance and commercial success of ZIMHI, the medical and commercial need for additional products and tools to help combat more powerful opioids, the effectiveness and success of ZIMHI in the treatment of opioid overdose, and other statements concerning Adamis’ future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause Adamis' actual results to be materially different from the results anticipated by such forward-looking statements. Adamis cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, Adamis undertakes no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the SEC, including its most recent annual report on Form 10-K and subsequent filings with the SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC's web site at http://www.sec.gov.

Contact:
Adamis Investor Relations
Robert Uhl
Managing Director
ICR Westwicke
619.228.5886
[email protected]

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