US WorldMeds is committed to the future
US WorldMeds is committed to improving the lives of our patients, both in the products that we market and in the therapies that are currently under development. This commitment can be seen in our pipeline, where we are diligently working to bring new therapies and new indications to patients across multiple therapeutic areas.
Opioid Withdrawal (Disorder)
Ongoing Clinical Trials
Clinical trials are the cornerstone of furthering our mission to improving the lives of patients. US WorldMeds is committed to sponsoring safe and effective trials that help to better the lives of patients.
|Opioid Withdrawal (Disorder)
|Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids
Grant and Research Support
Thank you for your interest in US WorldMeds. As part of our goal to positively change lives through improved healthcare, we are strongly committed to supporting independent medical education activities and Investigator-Initiated Research (IIR). Please see the guidelines below for submitting Medical Education Grant Requests and IIR Requests. We look forward to reviewing your application.
Support by US WorldMeds of independent medical education activities is limited to only those that fall within the company’s specific areas of therapeutic focus. Please see several examples listed below:
- Increasing awareness of opioid withdrawal syndrome (OWS) and available treatment options
- Educating on differences between opioid dependence, opioid tolerance, and Opioid Use Disorder (OUD)
- Funding for medical fellowships/scholarships
The completed medical education grant request application should be sent electronically to our Medical Affairs Department at [email protected].
A full description of all necessary documents is outlined in the Guidelines for Medical Education Grant Requests.
Please check back periodically for any updates to current areas of therapeutic focus.
US WorldMeds recognizes that IIRs enable research that has the potential to improve the lives of patients with challenging conditions and unmet medical needs. The program is offered to all institutional and community-based scientists and clinicians who are interested in conducting their own research, and support is awarded based on the scope of the proposal and its scientific merit.
In general, IIRs are smaller in scale than Phase IV Research and are "proof of concept" or "exploratory" in nature. US WorldMeds may provide funding and other forms of support, such as clinical trial materials, to support studies initiated and sponsored by outside researchers.
For consideration of support, a complete IIR proposal should be sent electronically to our Medical Affairs department at [email protected]. Furthermore, in order to protect the ideas of those we work with, please fill out the highlighted fields in this 2-way Confidential Disclosure Agreement (CDA) prior to submitting a complete proposal.
A complete proposal includes the following:
- The IIR Request Form filled out in its entirety
- Full Study Protocol
- A curriculum vitae for each interested investigator and any co- and/or sub-Investigators (if applicable)
- A comprehensive and detailed proposed budget (in U.S. dollars), if applicable
- Other supporting documentation
For an initial review of a proposed study concept only to gauge the interest of US WorldMeds for support, please fill out and send back the IIR Request Form and CDA to [email protected].
Lofexidine Areas of Interest:
- Treatment of opioid withdrawal symptoms with lofexidine in patients without OUD (e.g., patients with chronic pain) to support abrupt opioid discontinuation or tapering off from short- or long-acting opioids
- Treatment of opioid withdrawal symptoms with lofexidine after acute naloxone administration
- Improving the rate of successful conversion to depot naltrexone using lofexidine for withdrawal
The complete IIR proposal should be sent electronically to our Medical Affairs Department at [email protected]. The IIR Request Form filled out in its entirety, along with submission of all other supporting documentation, constitutes a complete proposal.
If US WorldMeds is able to provide funding/support for the medical education activity or research trial, a Letter of Agreement (provided by US WorldMeds) must be signed by US WorldMeds and the Medical Education Provider or Independent Research Organization.
Any activity for which support is awarded is required to be compliant with and adhere to federal and state guidelines and regulations, including, but not limited to, the FDA Final Guidance on Industry-Supported Scientific and Educational Activities, the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, the American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians from Industry, and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals, where applicable.
All grant and research support is awarded at US WorldMeds' sole discretion. Approval of grant funding or research support is never related to or conditioned upon past, promised, or potential future prescriptions or purchases of US WorldMeds' products. US WorldMeds does not offer or provide medical education grants or research support to encourage or to reward the prescription, purchase, ordering, or recommending of US WorldMeds products.
If you have any questions regarding independent medical education grants or IIRs, please contact our Medical Affairs Department at [email protected].
Expanded Access Policy
US WorldMeds is committed to serving patients by providing safe, fair, and sustainable patient access to its medicines. US WorldMeds may be able to provide patients access to its investigational drugs outside of a clinical trial if certain conditions are met and if permitted by local law and regulation. The use of an investigational medical product (i.e., one that has not been approved by the Food and Drug Administration [FDA]) outside of a clinical trial is known as Expanded Access (sometimes referred to as “compassionate use”). Expanded Access may not always be available and requires the individual patient to meet certain eligibility conditions as outlined below:
- The patient has a serious or life-threatening illness
- Both the patient and his or her licensed physician are willing to participate
- The patient’s physician determines there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition
- The probable risk to the patient from the investigational product is not greater than the probable risk from the disease or condition
- FDA determines there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance
- FDA determines that providing the investigational product will not interfere with the initiation, conduct, or completion of clinical investigations to support marketing approval
- The sponsor or the clinical investigator submits a clinical protocol that is consistent with FDA’s statute and applicable regulations for Investigational New Drugs (IND) or Investigational Device Exemption (IDE), describing the use of the investigational product
- The patient is unable to obtain the investigational drug under another IND or to participate in a clinical trial
Generally, there are two types of Expanded Access—Group Expanded Access and Individual Patient Expanded Access. Currently, US WorldMeds offers Individual Patient Expanded Access. Individual patient access is managed by the patient’s physician. For a patient to receive an investigational product through Individual Patient Expanded Access, his or her physician must submit a request to the FDA on behalf of his or her patient.
US WorldMeds currently does not offer any Group Expanded Access programs. In the event US WorldMeds begins accepting requests for Group Expanded Access, this website and policy will be updated with a hyperlink or other reference to the Expanded Access record on clinicaltrials.gov.
For more information on the different types of Expanded Access, click here.
Physicians may also contact US WorldMeds with questions regarding Expanded Access at [email protected]. US WorldMeds employs a team of medical professionals who are familiar with the investigational drugs available, and can help physicians through the Expanded Access application process. US WorldMeds anticipates that it will respond within five (5) business days of receipt of the communication.
In line with the 21st Century Cures Act, US WorldMeds cannot guarantee access to our investigational products to all patients. US WorldMeds may revise this policy at any time; at such time, the website and policy will be updated accordingly.