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FDA reviewers say Titan drug results not as strong as hoped
March 19, 2013 / 1:00 PM / 5 years ago

FDA reviewers say Titan drug results not as strong as hoped

March 19 (Reuters) - Titan Pharmaceuticals Inc’s experimental drug to treat opioid addiction was shown to be more effective than placebo in a clinical trial, but the results were not as strong as might be hoped, reviewers for the U.S. Food and Drug Administration said in documents published on Tuesday.

The reviewers’ commentary was published on the FDA’s website ahead of an advisory panel meeting to be held on Thursday. The reviewers said results of the trial prompt speculation that Titan’s drug needs to be given at a higher dose and they asked the panel to advise on whether the company should explore dosing further before the product is approved.

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