The one-year trials involved a total of about 3,800 patients.
At a lower dose, 39.5 percent of Contrave patients lost at least 5 percent of their weight. Orexigen said it would not pursue development of a third dose, the highest tested, since it did not show increased effectiveness.
One of the FDA guidelines for a weight loss drug is that there be a 5 percentage point difference in weight loss between the test drug and placebo.
The numbers indicate to us that the drug is both approvable and commercially meaningful," Natixis Bleichroeder analyst Corey Davis said in a research note.
Orexigen said 48 percent of obese patients on a higher dose of Contrave lost at least 5 percent of their body weight, compared with 16.4 percent of those given a placebo in one trial. The same dose in another trial showed that 56.3 percent of patients achieved at least 5 percent weight loss vs. 17.1 percent of the placebo group.
"We practically tripled" the effectiveness, Orexigen Chief Executive Mike Narachi told Reuters.
Contrave is a pill that combines the antidepressant Wellbutrin, known generically as bupropion, with a sustained-release version of naltrexone, an opioid blocker used to treat alcoholism and other addictions.
Narachi said Orexigen had decided not to seek FDA approval for Contrave until next year because it needs time to compile a "quality" new drug application.
At a lower dose, 39.5 percent of Contrave patients lost at least 5 percent of their weight. Orexigen said it would not pursue development of a third dose, the highest tested, since it did not show increased effectiveness.
One of the FDA guidelines for a weight loss drug is that there be a 5 percentage point difference in weight loss between the test drug and placebo.
The numbers indicate to us that the drug is both approvable and commercially meaningful," Natixis Bleichroeder analyst Corey Davis said in a research note.
Orexigen said 48 percent of obese patients on a higher dose of Contrave lost at least 5 percent of their body weight, compared with 16.4 percent of those given a placebo in one trial. The same dose in another trial showed that 56.3 percent of patients achieved at least 5 percent weight loss vs. 17.1 percent of the placebo group.
"We practically tripled" the effectiveness, Orexigen Chief Executive Mike Narachi told Reuters.
Contrave is a pill that combines the antidepressant Wellbutrin, known generically as bupropion, with a sustained-release version of naltrexone, an opioid blocker used to treat alcoholism and other addictions.
Narachi said Orexigen had decided not to seek FDA approval for Contrave until next year because it needs time to compile a "quality" new drug application.
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