Shares of Orexigen Therapeutics fell sharply in after-hours trading Jan. 8 after results of a late-stage obesity drug trial failed to meet FDA standards of weight change in patients compared with a placebo.
The stock fell $2, or 33 percent, to $4.05 in after-hours trading after closing at $6.05 that day. Orexigen trades on the Nasdaq as OREX.
Although the experimental drug, called Contrave, met study goals of weight reduction and cholesterol improvement, the drug showed little improvement over placebo.
Obese patients taking Contrave lost between 20 and 25 pounds, or 9.3 to 11.5 percent of their body weight, while those taking a placebo lost between 11 and 16 pounds, or 5.1 to 7.3 percent body weight. The weight-loss difference between the drug and placebo was 4.2 percentage points, slightly less than the FDA standard of at least 5 percentage points. Both groups followed an intensive diet and exercise regimen.
The study involved obese patients who were given treatments over the course of 56 weeks.
Oreixgen executives said, however, that they expect the results to satisfy the FDA’s benchmarks.
“The results of this trial indicate that additional, clinically significant weight loss can be achieved when Contrave is added to a rigorous program of diet and exercise,” Chief Medical Officer Eduardo Dunayevich said in a statement.
Orexigen has three other late-stage studies on the drug, with results due out this summer. The company said it expects to file an application with the FDA for Contrave by the end of the year.
, Heather Chambers
