Key FDA Committee Approves Titan Pharma's Bup Implant

Addiction Treatment Industry Newswire

04/29/2013 – ATIN – Despite a decidedly negative review of its Probuphine branded implantable long acting buprenorphine (Suboxone) by FDA staffers in recent weeks, tiny Titan Pharmaceuticals has managed to push through Probuphine’s approval by the key FDA Psychopharmacologic Drugs Advisory Committee, which voted last week to recommend that the FDA approve the implants and thus perhaps setting the stage for eventual bringing to market of Probuphine.

While it is relatively rare that the FDA would go against the advice of its advisory committee, the implants face many hurdles before becoming fully approved for widespread use. In the meantime, Suboxone – which is the biggest selling drug of all time in the addictions space behind methadone and last year brought a blockbuster $1.5B in revenue for its manufacturer Reckitt Benckiser – has been approved for generic status, with Amneal Pharmaceuticals getting the green light by the FDA to bring a generic buprenorphine/naloxone product to market.

While Titan Pharma’s stock price has gotten a boost in recent trading days, though today the stock gave back some of those gains, Titan Pharma is considered a penny stock and currently trades at a price of under $2 a share. More than anything, this illustrates that eventual commercialization of Titan’s Probuphine buprenorphine implants is far from certain and is years off from coming to market, otherwise Titan’s shares would easily be trading over $10 given the potential of a fully commercialized implant to upend and revolutionize the multi-billion dollar annual opiate maintenance therapy marketplace.

A buprenorphine implant that works and is safe solves many problems with respect to medication compliance and diversion, addictions medical experts say.

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