Summary
Considering the clear urgency, this SN encourages action related to a foundational element of the larger AOI to support the development and submission of an Investigational New Drug (IND) application for ibogaine to treat patients with Opioid Use Disorder (OUD) at increased risk of mortality. Specifically, ARPA-H invites submission of Solution Summaries to the PHO ISO for the following tasks: Plans to develop and submit an Investigational New Drug (IND) application for ibogaine to treat individuals with treatment-resistant OUD or OUD with an elevated risk of mortality due to recent nonfatal overdose. Proposed plans should include a strategy for regulatory engagement with the FDA and a clear risk mitigation plan for potential cardiotoxicity. Development of a safe clinical protocol for Phase 1 clinical trials based on gold standard science; and Develop plan for the procurement of sufficient quantities of good manufacturing practice (GMP)-grade clinical material for human studies to include (but not limited to) activities related to Chemistry, Manufacturing, and Control (CMC) processes and compliance with Federal requirements to important, handle, and administer Schedule 1 substances. See attached file.