Reuters: Regulatory News: UPDATE 1-FDA rejects Titan drug for opioid dependence

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UPDATE 1-FDA rejects Titan drug for opioid dependence May 1st 2013, 13:25 Wed May 1, 2013 9:25am EDT * FDA asks for more data on Probuphine * Titan shares fall 70 percent in premarket trading * Titan says extremely surprised and disappointed by ruling May 1 (Reuters) - U.S. health regulators rejected an experimental drug to treat opioid addiction made by Titan Pharmaceuticals Inc and asked for additional data showing it works, the company said. The drug, Probuphine, is a long-acting version of buprenorphine, a drug sold by Britain's Reckitt-Benckiser Group Plc under the brand names Subutex and Suboxone. Unlike Subutex and Suboxone, which are taken daily and dissolved under the tongue, Titan's drug is implanted under the skin of the upper arm during a 10- to 15-minute office procedure and delivers a continuous supply of buprenorphine for six months. Clinical data showed Probuphine to be more effective than placebo in curbing addiction, but an outside panel of experts to the FDA said in March that the data were not particularly robust and suggested the proposed Probuphine dose could be too low. Titan's stock fell 41 percent after the expert panel's comments on March 19. The stock plunged 70 percent to 5 cents in premarket trading on Wednesday. Titan, which announced the FDA decision shortly before midnight on Tuesday, said it was "extremely surprised and disappointed" with the agency's response. The formulation of Probuphine is consistent with recently issued FDA guidance supporting diversion and abuse-resistant drugs, the company said. Link this Share this Digg this Email Reprints

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