Background Analysis: US FDA Advisory Committee to Review Risk Evaluation and Mitigation Strategies for Transmucosal Immediate-Release Fentanyl Medicines – AUG 3, 2018 (AADPAC-DSRM)

Announcement

The US FDA has scheduled a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee for Friday, August 3, 2018. The Committees will discuss results from assessments of the transmucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategies (REMS).

Product Background

Opioid Drugs

Opioids are a class of small molecule drugs used to treat moderate to severe pain. Opioids work by reducing the perception of pain through binding to opioid receptors found in the brain, spinal cord, gastrointestinal tract, and other organs in the body. The FDA has approved several opioid-containing products, which include the following active ingredients: fentanyl, oxymorphone, hydromorphone, morphine, hydrocodone, and oxycodone. Among these, transmucosal immediate-release fentanyl (TIRF) medicines that are FDA-approved include the following medicines: Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal

Regulatory Background

US FDA Considerations for Opioid Drugs

The US is currently experiencing an epidemic of overprescribing, misuse and abuse of opioid drugs. Several US agencies have been undergoing efforts to evaluate and attempt to curb the opioid crisis.  On July 9, 2018, the FDA Commissioner, Dr. Scott Gottlieb, blogged about actions the FDA has been taking to confront the epidemic. In his blog, the Commissioner asserted that while the Agency is working to ensure more appropriate and rationale opioid prescribing, it will not lose sight of the needs of Americans living with serious chronic pain or coping with pain at the end of life, who need access to effective treatments. Thus, he said, “the FDA remains focused on striking the right balance between reducing the rate of new addiction by decreasing exposure to opioids and rationalizing prescribing, while still enabling appropriate access to those patients who have legitimate medical need for these medicines.”

REMS for TIRF Medicines

The REMS for TIRF medicines was approved in December 2011. The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use.

At the upcoming meeting, the Committee will hear the results from assessments of the TIRF REMS. The FDA will seek the Committees’ assessment as to whether this REMS assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system. The Agency will also seek the Committees’ input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met.

What’s Next?

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA and the Sponsor’s, if applicable, briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: various Drug Name: transmucosal immediate-release fentanyl Drug Class: opioid Indication: pain

For more information about SAC Tracker reports and other benefits for our subscribers, click here.

DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.