Makers of a subdermal implant of the opioid addiction medication buprenorphine this week received the support of an advisory committee to the Food and Drug Administration (FDA) regarding potential approval of their formulation. They now hope they don't see a repeat of 2013, when the FDA rejected the New Drug Application (NDA) for Probuphine after a positive recommendation from the advisory panel—over concerns at that time about the safety of the surgical procedure to implant the devices.
Titan Pharmaceuticals and development partner Braeburn Pharmaceuticals announced this week that the FDA's Psychopharmacologic Drugs Advisory Committee recommended approval of the Probuphine implant on a vote of 12-to-5. The approval would be for maintenance treatment in stable patients receiving no more than 8 mg of buprenorphine a day.
The target date for FDA action on the Probuphine NDA that was resubmitted last fall is Feb. 27.
At the advisory committee meeting, Braeburn presented recent data indicating Probuphine's effectiveness as a six-month maintenance treatment. The company also presented safety findings that focused on insertion and removal procedures for the implant, designed to be inserted in a patient's upper arm in an outpatient procedure.
Testimony that was read at the public hearing portion of the advisory panel meeting included written comments from behavioral health advocate and former U.S. Rep. Patrick Kennedy, who stated in part, “The active agent, buprenorphine, is already the go-to choice for providers and patients alike. The ability to now deliver the medication in a safer way for individuals, their families and society is truly a breakthrough.”