This morning, the company released data from two phase 3 trials -- named Equip and Conquer -- for its anti-obesity drug, Qnexa, and quite frankly, the drug looks outstanding.
In one study, patients at the highest dose in one study lost a placebo-adjusted 9.4% of their body weight. In the other, where patients were less obese, they lost a placebo-adjusted 8.6% of their body weight.
The other key measurement that the Food and Drug Administration uses to determine efficacy is the amount of patients that lost at least 5% of their body weight. That data looked just as good. In both studies, more than three times as many patients who completed the trial on the highest dose were able to achieve the 5% goal compared with placebo.
Just as importantly, the side effects seem to be mild. VIVUS's big brothers, Pfizer (NYSE: PFE ) , Merck (NYSE: MRK ) , and sanofi-aventis (NYSE: SNY ) all stopped development of their weight loss drugs because of adverse side effects.
Despite the lack of red flags, the FDA is still likely to scrutinize the safety data heavily. Qnexa is a combination of one of the drugs in Wyeth's (NYSE: WYE ) fen-phen -- albeit not the part that's believed to cause heart problems -- and the active ingredient in Johnson & Johnson's (NYSE: JNJ ) migraine and epilepsy drug, Topamax, which has side-effect issues of its own.
VIVUS said it plans to submit the data to the FDA by the end of the year, a timetable that could put it slightly ahead of Arena Pharmaceuticals (Nasdaq: ARNA ) and Orexigen Therapeutics, which are also developing weight-loss drugs.
There's probably plenty of room to run -- even after VIVUS' monster 70% gain today -- if Qnexa gets past the FDA, but because a decision won't happen until late next year, investors might as well take their time and wait to see how Arena's data turns out later this year before jumping into VIVUS.