Did the odds just get worse for Arena’s new weight drug?

After the FDA panel vote against Vivus's obesity drug Qnexa, analysts tracking the wave of new weight drugs headed to the agency have been hyper-sensitive about anything that could highlight concerns about the safety of the experimental treatments. So when the agency scheduled an in-depth review of Abbott's Meridia right ahead of Arena's (ARNA) lorcaserin--just as it tackled Avandia risks right ahead of the Qnexa session--it didn't take long for fresh fright to take hold. "The Meridia...

Orexigen weight-loss drug shows positive results in study

Results from COR-I, one of the Phase III trials supporting the NDA for Orexigen Therapeutics' (NASDAQ: OREX) weight-loss drug Contrave, show that patients taking the drug were two to three times more likely to lose at least 5 or 10 percent of their body weight compared with those taking placebo. The study results have been published online in the journal Lancet.   Treatment with Contrave also resulted in significant improvements versus...

Expert panel not convinced by Vivus’ Qnexa

GAITHERSBURG, MD -- Expressing the need for more information--especially about teratogenicity--an FDA expert panel has recommended against approval of Vivus' (NASDAQ: VVUS) obesity drug Qnexa. The vote was six in favor and ten against, with many of the no voters citing the need for more safety data. During the meeting, several of patients shared their experiences with Qnexa after taking the drug during clinical trials. They asked the committee to approve the drug, pointing to the...

Vivus’ Qnexa takes center stage during panel review

GAITHERSBURG, MD -- After two long days of helping review Avandia, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee today is taking a look at Vivus' (NASDAQ: VVUS) application for Qnexa (phentermine/topiramate CR). We won't know until the afternoon how the panel will vote, but during its presentation, Vivus highlighted the current medical need for an obesity treatment, as roughly 33.8 percent of the U.S. adult population is obese. Ahead of the meeting, TheStreet's Adam...

Vivus shares rally after FDA staffers detail Qnexa concerns

With an expert panel review looming in two days, FDA staffers outlined a series of potential risks associated with the weight-loss drug Qnexa. But the agency also recognized the drug's ability to trigger significant weight loss, and analysts who have been following the therapy didn't immediately trigger any alarms about the risk analysis as VVUS shares soared in premarket trading. At extremely high doses, Qnexa--a combination of phentermine and the anti-convulsant topiramate--has been linked to...

Spotlight shifts to Vivus’ Qnexa

Few developers have enjoyed the kind of attention that's been lavished on the three biotech companies seeking approval for their new obesity drugs. The focus will hit fever pitch Thursday when an FDA advisory panel steps up to review Vivus' (NASDAQ: VVUS) Qnexa. All the developers--including Orexigen (NASDAQ: OREX) and Arena (NASDAQ: ARNA)--have a lot riding on the outcome. As the Wall Street Journal explains, the agency plans to review each of the drugs as candidates for...