FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Psychopharmacologic Drug Advisory Committee (PDAC)
The joint committee met to discuss the efficacy, safety, and risk-benefit profile of the new drug application (NDA) for ALKS-5461 (buprenorphine and samidorphan sublingual tablets), submitted by Alkermes, Inc. (Alkermes), for adjunctive treatment of major depressive disorder (MDD).
A majority of the joint committee, 21 of 23 members, voted that the available data do not support a favorable benefit-risk profile of ALKS-5461 to support its approval. Two of 23 joint committee members voted that the available data do support its approval.
The Committee voted unanimously (12 of 12 members, with no abstentions) that the data provide substantial evidence of effectiveness of lofexidine for the mitigation of symptoms associated with opioid withdrawal. A majority of the Committee (11 of 12 members, with no abstentions) voted to recommend approval of the lofexidine NDA.
The Committees supported approval of some of the proposed doses of buprenorphine subcutaneous injection (CAM2038), submitted by Braeburn Pharmaceuticals, Inc., (Braeburn), for the treatment of opioid dependence.
The Committees supported, by a vote of 18-Yes to 1-No, with no abstentions, the approval of buprenorphine subcutaneous injection (RBP-6000), submitted by Indivior Pharmaceuticals, Inc. (Indivior), for the treatment of opioid dependence.
The Committee will discuss new drug application (NDA) 209241, Valbenazine 40 mg capsules, for the proposed treatment of Tardive Dyskinesia, submitted by Neurocrine Biosciences, Inc.
A majority of the Committee members, 10 of 19 members, voted that the FDA should remove the boxed warning statements regarding the risk of serious neuropsychiatric (NPS) adverse events (AEs) associated with Chantix.
Five of the 19 members voted that the FDA should keep the boxed warning statements.
Four of 19 members voted that the FDA should modify the language of boxed warning statements.
The Committee supported, by a vote of 12-Yes to 2-No, with no abstentions, the safety and efficacy of Nuplazid (pimavanserin), submitted by Acadia Pharmaceuticals Inc. for the proposed treatment of psychosis associated with Parkinson's disease. The PDUFA date for pimavanserin is May 1, 2016.
The Committee considered the clinical presentation and assessment of cognitive dysfunction in major depression (MDD). The Committee supported, by a vote of 8-Yes to 2-No, with no abstentions, a new claim for the treatment of cognitive dysfunction in MDD for Brintellix (vortioxetine), based on the data that was submitted in a supplemental New Drug Application (sNDA) by Takeda Development Center Americas, Inc. (Takeda).
The Committee supported, by a vote of 12-Yes to 5-No, with no abstentions, the safety and efficacy of PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc. (Braeburn), on behalf of Titan Pharmaceuticals (Titan) for the proposed indication of maintenance treatment of opioid dependence, in patients who are stable on buprenorphine at a dose of 8 mg or less. Exact wording of the indication is to be determined.
The Committee reviewed Fabre-Kramer Pharmaceuticals’ Gepirone Extended Release (gepirone) for major depressive disorder (MDD). A majority of the Committee, 9 of 13 members, voted that the available data do not support a favorable benefit:risk profile for the proposed use to treat MDD.
Psychopharmacologic Drug Advisory Committee (PDAC)
PDAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields and makes appropriate recommendations to the Commissioner of Food and Drugs.