The focus in the media this week may be on the US Food and Drug Administration’s deliberations around what to do with the diabetes blockbuster Avandia. Yet the agency’s advisory committee on endocrinologic and metabolic drugs has another drug to consider as well.
On Thursday, the panel will turn its attention at Qnexa, the weight-loss drug developed by Mountain View, California-based Vivus. The drug is yet to be approved, but in two phase 3 clinical trials subjects on the medicine — a combination of the appetite suppressant phentermine and the anticonvulsant topirimate — lost a placebo-corrected average of 9% of their body weight. A phase 2 trial also demonstrated Qnexa’s efficacy against sleep apnea.
But the drug has also been linked to anxiety, depression and concentration lapses, among other ailments, according to briefing documents released today. The report also questioned the lack of data in pregnant women and on long-term cardiovascular safety.
If Qnexa gets the advisory committee’s blessing, it could mean big business for Vivus and a head start over the company’s competitors, California-based Arena Pharmaceuticals and Orexigen Therapeutics, which both have new obesity drugs in development. Arena’s Lorcaserin and Orexigen’s Contrave will face similar scrutiny by the same panel later this year. The London-based market research agency Datamonitor estimates that the global diet-pill market could exceed $10 billion by 2018, Bloomberg reports.
For more on these new antiobesity drugs, check out our news story from earlier this year.