Braeburn/Titan Nab Powerful Ally To Push Opioid Dependence Implant
With the FDA's approval in hand, the big question now is whether payers will pay for Braeburn Pharmaceuticals' and Titan Pharmaceuticals' opioid dependence implant Probuphine, whose wholesale acquisition cost has been set at $825 per month. But the companies have a strong ally on their side: Nora Volkow, head of the US National Institute of Drug Abuse, who called the product a "game-changer."
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Even with new data, US regulators appeared to question whether Titan Pharmaceuticals Inc. and its partner privately held Braeburn Pharmaceuticals Inc. can safely market Probuphine, a matchstick-size subdermal implant intended to deliver buprenorphine to treat opioid dependence.
With new positive Phase III results in hand, Titan Pharmaceuticals on 8 June said it will be ready by the second half of this year to resubmit its new drug application (NDA) to the FDA for Probuphine (buprenorphine hydrochloride/ethylene vinyl acetate), a subdermal implant that's under investigation as a maintenance treatment for opioid addiction.
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.