Psychopharmacologic Drugs Advisory Committee; Notice of Meeting
Date and Time: The meeting will be held on March 21, 2013, from 8 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002.
Agenda: On March 21, 2013, the committee will discuss new drug application (NDA)
204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal
implant, submitted by Titan Pharmaceuticals, Inc., and its safety and efficacy for the proposed
indication of maintenance treatment of opioid dependence.
Procedure: Interested persons may present data, information, or views, orally or in
writing, on issues pending before the committee. Written submissions may be made to the
contact person on or before March 14, 2013. Oral presentations from the public will be
scheduled between approximately 1:45 p.m. and 2:45 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and submit a brief statement
of the general nature of the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time requested to make their
presentation on or before March 6, 2013. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a lottery to determine the
speakers for the scheduled open public hearing session. The contact person will notify interested
persons regarding their request to speak by March 7, 2013.
I am really glad there is going to be an adcom. In my opinion, the fda would probably not have convened this if they had some clear reason in mind to reject the application. A strong vote in the adcom would set up a lot of pressure on the fda to approve. I think a strong favorable vote is very likely given the problems with opiate abuse and the growing acceptance of buprenorphine for its treatment. I have been reading many accounts of addiction and I can find little negative on buprenorphine, especially compared to methadone which is the drug from hell. It seems methadone can take literally months to detox from -