Tuesday, July 21, 2009

late-stage trials of Contrave experimental

Orexigen Therapy Inc. (OREX.O)said, the process of Contrave experimental weight loss drug rave step 3,almost meet their target and rise up nearly 25% of their shares.

Headquartered in San Diego and as a result of the plan to get U.S. regulatory approval in the first half of next year, the clinical criteria of significant weight loss Food and Drug Administration.

"These numbers are a drug is approved, the commercial sense," analyst Corey Davis contact details Bleichroeder Natixis 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 are efficient 3 times better, said Orexigen CEO, Mike Narachi.

Contrave is a pill for antidepressant Wellbutrin, bupropion is a well-known, pending the release of naltrexone, OPIOIDOBUROKKA used to treat addiction and alcoholism.

Narachi Orexigen reason, the "quality" time for the NDA to the FDA next year has decided not to contact the rave for approval.

About 3,800 patients involved of 1 years trials.

Lower dose, weight at least 39.5 percent of patients rave 5% lose contact. Orexigen is developing three of the second dose, in order to improve the effectiveness of the test, that's not the best.

Is a weight-loss drugs, FDA guidelines, and 5% difference in body weight or placebo at the time of drug testing.

The main test of a single dose, patients, average weight loss 6.1%, placebo 1.3% - 4.8% points. In both tests was 5.2% points.

January 2007, contact Orexigen rave in absolute weight difference was 4.2 percent, announced the final results of the first stage of the experiment.

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