Local pharmaceutical company's new drug questioned by federal panel
Original post made by Nick V on Jul 15, 2010
The drug, developed by Mountain View's [Web Link Vivus Inc.], is called [Web Link Qnexa], and combines two compounds -- phentermine and topiramate -- to battle weight gain by controlling appetite and satiety.
According to the [Web Link Wall Street Journal], voted 6-to-10 against a question asking whether the "overall risk-benefit assessment of Qnexa is favorable to support approval."
Dan Budwick, a spokesman for Qnexa, said the ruling is only a recommendation and that a final FDA decision will not come until Oct. 28.
If the drug is ultimately approved, it will be the first weight-loss drug to hit the market in more than a decade.
Despite promising results in reducing weight loss during clinical trials, the panel was concerned about the potential for long term side-effects, such as heart problems and birth defects. Many members of the panel said they would not feel comfortable approving the drug until they saw more data, according to the Journal's report.
on Jul 15, 2010 at 5:05 pm
Maybe Mr. Lucero will sue. Better yet, maybe he will run for a position on the FDA. Even better, maybe those suffering from too much feeding, can just use medical marijuana to solve their problems. Oh wait... .