Sunday, June 23, 2013

BRIEF-FDA advisers find Titan's Probuphine useful, express concerns on REMS plan

March 21 (Reuters) - Titan Pharmaceuticals Inc :

* FDA advisers vote 10-5 to agree clinical study data on Titan'S Probuphine

give substantial proof of its effectiveness to treat opioid dependance

* FDA advisers vote 12 yes, 2 no, 1 abstain on whether Titan adequately

characterized safety profile of Probuphine in the intended patient population

* FDA advisers vote 5 yes, 4 no, 6 abstain on whether rems proposed by Titan

are adequte to address risks of potential complications of Probuphine use

* FDA advisers vote 10 yes, 4 no, 1 abstain on whether efficacy, safety and

risk-benefit profile of Titan'S Probuphine support drug's approval

* Further company coverage ((Bangalore Newsroom; +1 646 223 8780))


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