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FDA panel backs approval of first opioid addiction implant

Probuphine has been developed by Titan Pharma and partner Braeburn Pharma
Opioid addiction

An FDA panel has backed approval of a long-acting buprenorphine implant for the management of opioid addiction developed by Titan Pharma and partner Braeburn Pharma.

If approved by the FDA, the implant - which has the proposed trade name Probuphine - would be the first product providing "continuous around-the-clock levels of buprenorphine for six months following a single treatment", according to Titan's executive chairman Marc Rubin.

At the moment the drug is only available in oral formulations that require daily dosing, and making an implant available could make it easier for patients to comply with addiction therapy, according to the two companies.

In trials, Probuphine was shown to be non-inferior to daily treatment with oral buprenorphine, which is a partial opioid receptor agonist. The drug is designed to provide some of the euphoric effects of drugs like heroin, helping patients come off the illicit substances without experiencing withdrawal symptoms.

The FDA committee voted 12 to five in favour of approval of Probuphine as an alternative to oral therapies in patients currently taking 8mg or less of the active drug per day, setting up a possible approval by the US regulator before the end of next month.

Overall, panellists were in favour of approval of the product, noting that there was evidence of efficacy and no evidence of risk, although not all were convinced of the robustness of the clinical data on non-inferiority.

The implant could potentially help prevent the diversion and misuse of oral buprenorphine products - said to be a big problem in the US, with reports of addicts selling prescribed doses to help fund the purchase of illegal drugs.

Titan and Braeburn attempted to secure US approval for their product in 2013 but were knocked back by the FDA, which asked for more information on the effect of the product at higher doses as well as the insertion and removal of the implant, which requires a minor surgical procedure.

At the committee meeting, Braeburn presented summary safety findings with a particular focus on the Probuphine insertion and removal.

Titan's ProNeura drug delivery platform can provide low-dose, non-fluctuating levels of certain medications in the bloodstream over extended periods of time ranging from three months to a year.

The company is also testing the technology to deliver Parkinson's disease therapy ropinirole and levothyroxine for people with hypothyroidism.

Article by
Phil Taylor

14th January 2016

From: Regulatory



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