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 Feuerstein said he believes the panel will vote to recommend Qnexa's approval. However, he predicted a mixed/close vote. "This will not be a landslide victory for the drug," he writes.
The company addressed some safety concerns during its presentation. Among during this morning's presentation, including psychiatric side effects, which it says were more frequent on Qnexa, but were typically mild and not associated with increased use of antidepressant medications. Furthermore, these events were identifiable early, and there was no increased risk of suicidality.
During his presentation, Gideon Koren said during Qnexa trials, there were 13 healthy live births with no malformations in patients taking the drug. There had been some concerns because at extremely high doses, Qnexa--a combination of phentermine and the anti-convulsant topiramate--has been linked to fetal malformations. However, the company will recommend against weight loss during pregnancy in its proposed labeling and advise women not to take the drug is they are pregnant or attempting to become pregnant. During the trial, women were required to be on contraceptives. Half of those who became pregnant used oral contraceptives, while others used barrier methods, the company said during the meeting. However, it didn't confirm compliance.
The company also reviewed its post-approval outcomes trial, which will be a randomized, parallel, controlled study. The primary endpoint will be the rate of the composite of myocardial infarction, stroke, arterial revacularization, hospitalization for unstable angina or death from cardiovascular causes or cancer.
Analysts estimate Vivus' drug could take in nearly $689 million in sales by 2014, according Reuters.