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FDA-backed study provides path forward for Probuphine

 
• By Donna Young

Titan Pharmaceuticals and its partner Braeburn Pharmaceuticals on 3 March said they have agreed in principle with the US FDA on the design of a trial to support the resubmission of the new drug application (NDA) for Probuphine (buprenorphine hydrochloride/ethylene vinyl acetate), a subdermal implant under investigation as a maintenance treatment of opioid dependence.

Titan Pharmaceuticals and its partner Braeburn Pharmaceuticals on 3 March said they have agreed in principle with the US FDA on the design of a trial to support the resubmission of the new drug application (NDA) for Probuphine (buprenorphine hydrochloride/ethylene vinyl acetate), a subdermal implant under investigation as a maintenance treatment of opioid dependence.

The FDA had rejected the Probuphine NDA on 1 May 2013 (scripintelligence.com, 1 May 2013).

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