FDA delays review date for Orexigen's obesity drug
Company's stock falls on news
- FDA review of Orexigen’s weight loss drug, Contrave (NB-32), has been delayed until September 11. Thestock fell 15% Thursday morning after a 30% run-up in the last month.
- Orexigen recently resubmitted its NDA after FDA requested additional data on cardiovascular outcomes.
- The phase III trial evaluating Contrave has allowed Orexigen to provide FDA with a large amount of additional data on cardiovascular outcomes.
Before data from the phase III study became available, Contrave (naltrexone SR/bupropion SR) had already been evaluated in more than 4,500 patients and had generated positive results with respect to efficacy and tolerability. In earlier trials, 53% of Contrave-treated patients versus 21% of placebo-treated patients lost at least 5% of their body weight and kept it off for at least 12 months. Contrave-treated patients also experienced improvements in cholesterol and blood sugar levels.
While the evidence indicates that Contrave supports weight loss, more data was requested by FDA to rule out excess cardiovascular risk in the obese subjects being studied -- especially considering previous situations in which obesity therapy was linked with CVD events.
This randomized, double-blind, placebo-controlled study enrolled 8,900 overweight patients with at least one cardiovascular risk factor, including women over age 50 and men over age 45. Trial size has allowed Orexigen to collect data based on a strong sample size and rigorous analysis.
Assuming that the safety data and other data the FDA has requested is sufficiently strong, Contrave could be in the US market by late 2014. Clearly, there is strong demand for anti-obesity drugs and drugs that decrease the risk of experiencing a cardiovascular event.
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