Pharmaceutical

FDA panel recommends approval of drug to treat heroin, prescription drug addiction

fda logo FDA panel recommends approval of drug to treat heroin, prescription drug addictionA Food and Drug Administration (FDA) advisory panel voted to recommend the approval of a small, experimental implant to treat heroin and prescription drug addiction. The drug, Probuphine, made by Titan Pharmaceuticals, is a matchstick-sized implant that is designed to help addicts overcome their habit.

The panel voted 10-4 with one abstention to approve the drug. If approved, the drug could receive a $50 million milestone payment. Titan purchased the U.S. and Canadian rights to Apple Tree Partners’ Braeburn Pharmaceuticals.

Opioid dependence is a rapidly growing public health concern and we remain committed to expanding the treatment options available to physicians and patients to manage this chronic condition,” Titan said in a statement.

Panel members said that opioid addiction is a disease that can have very tragic consequences. Treating it is paramount; however, some panel members expressed concerns that more safety data would be needed. The panel voted 5-4 with six abstentions to approve the drug with a risk mitigation plan in place to track side effects.

The committee also questioned whether a one-time training program for physicians would be enough to avoid potential complications with the implantation of the device.

All committee members agreed that heroin and prescription drug addiction is a serious and life threatening problem that must be addressed.

Currently, addicts can use the drug Suboxone, a dissolvable tablet that combines buprenorphine with naloxone, which is used to reverse the effects of overdose. Another drug, Zubsolv, is pending FDA approval in July to treat opioid addiction.

The FDA is not required to follow the recommendations of its advisory panel, however it usually does.

Source: Bloomberg