PDUFA date extended to May 2016
In January, an FDA Advisory Committee recommended approval of Titan Pharmaceuticals Inc (O:TTNP) lead product, Probuphine, the first long-acting form of buprenorphine delivered through an implant, as maintenance treatment for opioid addiction. Probuphine uses Titan’s ProNeura long-acting subdermal implant technology. On 19 February, the decision date was delayed until 27 May. Separately, Titan requested a pre-IND meeting for its Parkinson’s disease therapy and recently added a candidate for hypothyroidism to its pipeline.
Strong data lead to a likely approval
In April 2013, the US FDA dealt a setback to Titan by requesting additional studies to look at Probuphine’s efficacy and safety, in addition to studies to ensure that physicians were adequately trained to insert and remove the implants. The primary measure of response in the new study was a clean (opioid-free) urine sample in at least four of the six months in the study. This Phase 3 study, submitted to the FDA in September 2015, had response rates of 96.4% for the Probuphine arm and 87.6% for the sublingual buprenorphine/naloxone arm. In addition, 88% of patients receiving Probuphine had clean urine samples for all six months, compared with 72% of patients receiving Suboxone.
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