FDA panel OKs Titan's addiction drug delivery platform

Titan Pharmaceuticals' ($TTNP) opioid addiction treatment Probuphine, which delivers a drug via a small implanted device placed under the skin, recently gained backing from an FDA advisory committee.

The subdermal implant, about the size of a matchstick, is designed to deliver consistent doses of buprenorphine for 6 months following a single treatment. The company states that this method of delivery helps patients stick to their treatment better than daily sublingual doses, which for addicts can be a difficult regimen.

The FDA's advisory committee, made up of nonagency experts, voted in favor of approval in a 10-4 decision with one abstention. Titan approached the agency last year with an NDA for Probuphine, now with an FDA action date of April 30.

Titan Executive Chairman Marc Rubin told FierceDrugDelivery that the company is also looking at other viable uses for the delivery method that Probuphine employs. He said Titan is looking into a proof of concept for the treatment of Parkinson's disease via a similar subdermal implant, as well as other possible uses.

"Any disease where long-term delivery will make a difference could benefit from this type of system," Rubin said. "Having steady-state levels of medication is important for avoiding some of the side effects of on-and-off dosing."

- here's the release

Related Articles:
FDA staff review raises big questions about fate of Titan's Probuphine
Twice-yearly opioid dependence implant steps closer to the market
Titan plans Q3 NDA submission for controlled-release implantable addiction treatment

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