FDA panel backs Probuphine

FDA's Psychopharmacologic Drugs Advisory Committee voted 10-4, with one abstention, in support of approval of an NDA for Probuphine buprenorphine from Titan Pharmaceuticals Inc. (OTCBB :TTNP) to treat opioid dependence. The committee also voted 10-5 that the clinical data provides substantial evidence of efficacy, and 12-2, with one abstention, that Titan adequately characterized Probuphine's safety profile. The panel voted 5-4, with six abstentions, that Titan's proposed REMS, which includes restricted distribution and a training program for doctors, is adequate. Titan attributed the large number of abstentions to the fact that the REMS program is still under discussion with FDA. Titan was off $0.03 to $1.23 on Thursday.

Shares of Titan fell 42% on Tuesday after FDA reviewers questioned whether further dose exploration of Probuphine should be required prior to approval in briefing documents released ahead of the meeting. The reviewers also expressed concerns about the implantation procedure for the product (see BioCentury Extra, March 19). ...