FROM AN FDA TELEBRIEFING

Clinicians may soon have a wider array of medicines that achieve effective pain management for those with legitimate need, but that also address the current public health crisis of prescription opioid diversion and abuse.

The FDA is leading that effort with its newly available document guiding industry in the evaluation and labeling of abuse-deterrent opioids, Dr. Douglas Throckmorton , deputy director of regulatory programs for the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, announced in a telebriefing held on April 1.

Entitled “Abuse-Deterrent Opioids – Evaluation and Labeling,” this FDA document provides guidance and recommendations for the pharmacy industry. While the document does not have immediate impact on prescribing practices, prescribers can expect to see development of a wider array of products using a variety of strategies to deter abuse, thanks to the clarification provided by this document and the expedited review of abuse-deterrent opioid formulations offered by the FDA.

A particular area of interest has been novel naloxone-containing opioids. Naloxone, an opioid receptor antagonist, quickly and powerfully reverses the effect of opioids and is particularly effective at reversing respiratory depression, a common proximate cause of death in opioid overdose.

Other chemical or physical formulations, the inclusion of aversive substances, and the use of abuse-resistant delivery systems are strategies encouraged by the draft document.

Ensuring the availability of more opioids with abuse-deterrent formulations is an important public health measure to stem opioid abuse, and the FDA is but one of several federal agencies working on this problem. The guidance document was issued to provide industry with the FDA’s current thinking regarding the studies that should be conducted, how drugs should be evaluated, and what labeling claims may be approved, said Dr. Throckmorton.

The FDA is focused on supporting the development of these medications to balance the need of those in pain while reducing abuse. To that end, applicants can also expect an expedited review process. “Tackling the opioid epidemic is a high priority for the FDA,” noted Dr. Throckmorton.

Further guidance regarding generic opioids with abuse-deterrent properties is expected soon. Dr. Sharon Hertz, acting director of CDER’s Division of Anesthesia, Analgesia, and Addiction Products, noted that current FDA and state laws still govern substitutability of generic opioids.

Today’s telebriefing caps off a period of brisk activity. An October 2014 public meeting regarding a draft guidance document was followed by a public comment period. To date, the FDA has met with more than 30 manufacturers interested in producing abuse-deterrent opioid formulations, noted Dr. Throckmorton.

fpnews@frontlinemedcom.com

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