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Orexigen Defines A Way To Get The Contrave PDUFA Clock Ticking

 
• By Jessica Merrill

The summary report of an interim analysis of the ongoing LIGHT clinical trial evaluating the cardiovascular safety of the obesity medicine can form the basis of a resubmission of the Contrave NDA, the company announced, shaving some time off the PDUFA clock.

Orexigen Therapeutics Inc. is anxious to see its obesity medicine Contrave (naltrexone SR/bupropion SR) reach the market after watching two competitors pass by in the neck-and-neck race to bring the first novel obesity medicines to market in 13 years. The NDA for Contrave has been stalled at FDA after the agency required Orexigen to conduct a cardiovascular outcomes study in 2011 Also see "Losing The Battle Of The Bulge: FDA Holds Up Orexigen's Contrave" - Pink Sheet, 1 February, 2011..

But the company announced some progress Jan. 7 on a proposal that will get the PDUFA clock for the application ticking a little faster. In response to Orexigen’s formal Dispute...

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