On February 2, 2022, I posted a blog on the Agency’s Guidance Agenda for 2022 (here) and chose seventeen of the ninety‑eight guidances listed that were my favorites for a number of reasons, but most of all due to what I felt was their significance. And, today, one of the guidances I had selected was released by the Agency.
Issued in draft today is Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry, which can be found in full here. The FDA acknowledges that the development of non‑opioid treatments for acute pain may be a significant benefit in reducing opioid exposure and potential abuse. The Agency outlines three aspects of importance in the development of such products in its draft guidance:
- Drug development programs appropriate for non‑opioid analgesics to support indications for the management of acute pain (“acute pain indication”)
- Availability of claims in labeling of non‑opioid analgesic products for acute pain regarding elimination or reduction of opioid use and the data needed to support those claims
- Use of expedited programs to support development programs for non‑opioid analgesics for the management of acute pain
There are three general sections to the guidance in which the Agency provides advice and direction:
- Non‑Opioid Analgesic Product Development for Acute Pain
- Potential Claims in Labeling for Non‑Opioid Analgesic Products for Acute Pain That Eliminate or Reduce Opioid Use and Data Needed to Support Those Claims
- Expedited Programs (potentially available to novel entities)
The FDA acknowledges that advancement in this arena is a priority given the current opioid health crisis. However, there has been little success over the years in developing alternate non‑addictive compounds, and, while non‑steroidal anti‑inflammatory drugs have been around for a long time, the next step in acute‑pain relief typically has moved to opioid treatment. Looks like the hunt is on, and, with this guidance, perhaps firms will view the potential for inclusion in the FDA’s priority review paradigm as incentive to invest in developing these classes of product.