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/
- 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
- ASAM National Practice Guidelines for the Treatment of Opioid Use Disorder, 2020 Focused Update
- LUCEMYRA™ [Prescribing Information]. Louisville, KY: USWM, LLC; 2018.