FDA Takes New Steps to Stimulate Development of Non-Opioids in Acute Pain Management

The United States Food and Drug Administration (FDA) has taken new steps aimed at fostering the development of non-addictive alternatives to opioids in acute pain management. The FDA targets pharmaceuticals against pain lasting up to 30 days, typically in response to some form of tissue injury such as trauma or surgery. Decreasing opioid exposure and preventing addiction are seen as core components of combating the opioid epidemic.

In a draft guidance, the FDA provides clear recommendations for companies developing non-opioid analgesics for acute pain. Three key aspects are highlighted:

Which types of drug development programs may be appropriate to generate the data needed to support an indication for acute pain management

The use of claims surrounding the elimination or reduction of opioids in drug labeling and the data needed to support those claims

Potential use of the FDA’s expedited programs to support the development program

The US government has prioritized beating the opioid epidemic and has taken express steps towards developing non-addictive alternatives to opioids in acute pain management. The full draft guidance can be found here.