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Orexigen On Quicker-Than-Expected Pace To Obtain Data Needed To Re-File NDA For Contrave

During its second quarter earnings call, the biotech said it sees recent FDA approvals of two other obesity drugs as a positive for its own prospects, but it is re-engaging with the agency on why it must perform a cardiovascular-outcomes trial prior to approval.

Recent FDA approvals of Vivus Inc.’s Qsymia (phentermine/topiramate) and Arena Pharmaceuticals Inc.’s Belviq (lorcaserin) are positives for Orexigen Therapeutics Inc. and its pipeline of two novel drugs for obesity, President and CEO Mike Narachi said during an investor call Aug. 7.

The company is continuing with a cardiovascular outcomes trial it must conduct in order to re-file an NDA for its lead compound, Contrave, but it also is asking FDA why...

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