Research & Development

Clinical Trials / Grants

US WorldMeds is committed to the future

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.

Eflornithine (DFMO)

Indication Phase Study Title Sponsor Link
High Risk/Very High Risk Medulloblastoma 2 Phase II Trial of Eflornithine/
DFMO as Maintenance Therapy for Molecular High-Risk/Very High-Risk and Relapsed/
Refractory
Medulloblastoma 		Beat Childhood Cancer Research Consortium Click Here
Relapsed/
Refractory High-Risk Neuroblastoma 		2 Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/
Refractory Neuroblastoma 		Beat Childhood Cancer Research Consortium Click Here
High-Risk Neuroblastoma 3 A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma Beat Childhood Cancer Research Consortium Click Here
High-Risk Neuroblastoma in Remission 2 NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoro-
methylornithine (DFMO) 		Beat Childhood Cancer Research Consortium Click Here
Tumors with increased LIN28 expression or MYCN amplification 2 NAn Intermediate Expanded Use Trial of DFMO Beat Childhood Cancer Research Consortium Click Here

Lofexidine

Indication Phase Study Title Sponsor Link
Neonatal Opioid Withdrawal Syndrome 2 A Phase 2, Open-Label, Randomized, Controlled, Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids Click Here
Opioid Withdrawal 1 A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subject Currently not active on clinicaltrials.gov but will be within 30 days of screening
Post Traumatic Stress Disorder 2 Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans Pharmaco-
therapies for Alcohol and Substance Use Disorders Alliance 		Click Here
Opioid Withdrawal 2 Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal (UH3) University of Pennsylvania Click Here

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.

Medical Education Grant Requests

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 grants@usworldmeds.com.
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.

Investigator-Initiated Research (IIR) Requests

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 grants@usworldmeds.com. 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 grants@usworldmeds.com.

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 grants@usworldmeds.com. The IIR Request Form filled out in its entirety, along with submission of all other supporting documentation, constitutes a complete proposal.

General Guidelines for Medical Education Grant and IIR Requests
The contact person at the requesting organization will be notified within three months of receipt of the application with the approval or denial status. Therefore, funding requests must be submitted no later than three (3) months prior to the date of the event, as applicable, to ensure sufficient time for internal review.

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 grants@usworldmeds.com.