FDA explores opioid alternatives, including psychedelics

The Food and Drug Administration (FDA) and the Reagan-Udall Foundation held a meeting about nonaddictive alternatives to opioids for treating addiction and pain management.

The details:

• Officials discussed potential regulatory pathways to help reduce patients’ reliance on opioids like methadone and buprenorphine to treat substance use disorder and oxycodone to manage pain.
• Wilson M. Compton, deputy director of the National Institute on Drug Abuse (NIDA), expressed enthusiasm for emerging therapies like psychedelics. He said he was “very excited” about the administration’s focus on psychedelic therapy and its potential as an alternative to opioids for treatment of addiction and certain pain conditions. But he cautioned that psychedelics remain “an area where the science is not yet proven.”
• The panel also championed developing federal guidance for at-home opioid disposal systems provided by outpatient pharmacies and highlighted how federal agencies have already advanced nonopioid options, including FDA’s approval last year of suzetrigine, a nonopioid medication to treat moderate-to-severe acute pain in adults.
• Officials stressed that alternatives should not come at the expense of patients who benefit from opioid medications.

The broader context:

• The Trump administration has cautioned against long-term use of opioid medications, including through a Substance Abuse and Mental Health Services (SAMHSA) Dear Colleague letter earlier this year that said providers should not rely solely on medications for opioid use disorder (MOUD) to treat opioid use disorder.
• FDA is ramping up attention on psychedelics. The agency is holding a public hearing on the potential therapeutic use of psychedelics today, seeking comment on issues pertaining to use in supervised settings (e.g., patient safety, access considerations, data collection, provider training and credentialing). FDA officials also published an opinion piece last week outlining how they expect to approach psychedelic drug applications. It underscores that FDA could consider alternative controls, like dosage differences, to traditional placebos that might risk unblinding trial participants. It also says that FDA is “receptive” to approving applications based on relatively short efficacy studies (e.g., 12 weeks), while requiring further study in the post-marketing period. FDA may mandate a Risk Evaluation and Mitigation Strategy for psychedelics to stipulate specific conditions to assure safe use.