US WorldMeds is committed to the future

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.

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.