San Diego-based Orexigen Therapeutics dumped a boatload of information in the public domain this morning about clinical trials of its experimental obesity drug. Investors have been in a wait-and-see mode about this drug for months after arguing over the merits of one big trial, but they reacted positively to this new batch of data, sending the stock up 16 percent to $6.62 just after the opening bell.
Orexigen (NASDAQ: OREX) said today that all three of the big clinical trials of the drug in obese patients reached their goals in showing that the treatment helped people lose more weight than a placebo. The company also said that it found encouraging signs on secondary goals, like reducing cholesterol, and blood sugar levels, and helping patients develop slimmer waists. There wasn’t much in the initial announcement about side effects, although Orexigen said nausea was the most common side effect that caused patients to drop out of the studies, and that seven out of 4,500 patients in the trials had severe side effects that may have been related to the drug, including gallbladder inflammation, seizure, heart palpitations, and vertigo.
The drug, a longer-lasting form of two generic treatments known as buproprion and naltrexone, has now cleared enough hurdles that Orexigen plans to send off an application to the FDA in the first half of 2010 to start marketing it in the U.S. as Contrave. If the FDA agrees the drug is safe enough to reach the market, then it has a shot to tap into a market surely worth multi-billions in the U.S. Obesity rates in the U.S. have been skyrocketing for years, as a result of the deadly combo of the sedentary lifestyle and junk-food culture. About two-thirds of U.S. adults are now considered overweight or obese, putting them at risk for a litany of conditions such as heart disease, diabetes, high blood pressure, and arthritis. The cost to society of all this unhealthy weight gain is hard to measure because it’s intertwined with so many diseases, but a U.S. Surgeon General’s report in 2000 fingered it as responsible for about 9 percent of national healthcare spending.
“The results demonstrate the potential for Contrave to help patients in their battle against obesity,” said Mike Narachi, president and CEO of Orexigen, in a statement.
Before breathless commentators start turning too many cartwheels though, it’s worth a closer look at the data to see what kind of magnitude of weight loss researchers saw with Orexigen’s drug.
The FDA has given guidance to drugmakers that it typically likes to see … Next Page »
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