FDA Panel Advises Approval of Drug for Opioid Dependence, With Concerns

A Food and Drug Administration (FDA) advisory panel recommended the agency approve a drug to treat opioid dependence, but voiced concerns about the safety of the manufacturer’s marketing plan.

The panel recommended approval of Probuphine, made by Titan Pharmaceuticals, Reuters reports. Members of the panel said they were concerned about the safety of the company’s marketing plan, because of the potential for abuse of the drug. They also said they were not convinced if the intended dose of Probuphine would be effective enough, the article notes.

The advisory panel voted 10-4 in favor of approving the drug, with one abstention. “I think it is a drug that we definitely need and the more we can put into our (opioid dependence) treatments, the better for our patients,” panel member Dr. Louis Baxter said.

Probuphine is a long-acting version of the opioid dependence medication buprenorphine. It is implanted under the skin of the upper arm, in a procedure that takes about 10 to 15 minutes in a doctor’s office. It remains in place for about six months. Doctors must be trained to implant the drug, and some of the FDA advisors said they were concerned Titan had not adequately planned for the training.

Five panel members voted “yes” on the question of whether Titan sufficiently addressed the potential danger of abuse and misuse of Probuphine, while four voted “no” and six abstained.

The FDA generally takes its advisory panels’ recommendations into consideration when it makes a final decision on marketing approval of a drug.