A Titan Pharmaceuticals device implanted just under the skin to release the anti-addiction medicine buprenorphine for six months prevented opioid abusers from relapsing equally as well as a daily buprenorphine, according to results from a phase III study announced Monday.
Titan and its partner Braeburn Pharmaceuticals believe positive results from the Phase III study will be sufficient to satisfy the concerns raised by the U.S. Food and Drug Administration when the device, known as Probuphine, was rejected in 2013.
A resubmission to the FDA is on track for later this year, Titan said. If approved in 2016, Probuphine, as it will be marketed, will be the first product to provide maintenance treatment of opioid addiction continuously for six months following a single procedure.
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