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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Asks Titan for More Trial Data on Anti-Opioid Drug

Dec. 24, 2013
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Titan Pharmaceuticals has been asked by the FDA to provide more trial data on its anti-opioid drug Probuphine, rejected by the agency in April. The study is required for approval because the FDA and Titan have agreed to change the subdermal implant’s proposed indication to better its prospects, Titan said Monday.

The change primarily addresses a shared concern of FDA reviewers and advisors: the effect of higher doses of Probuphine.

According to official minutes from a Nov. 19 meeting with the agency, the studies can be small but must support 6 months’ worth of labeling.

Titan is developing the drug with Braeburn Pharmaceuticals, which has licensed the commercialization rights for Probuphine in the U.S. and Canada. — Lena Freund