FDA rejects another obesity drug
The FDA has rejected the new drug application for Vivus' investigational obesity drug Qnexa (phentermine/topiramate), stating that the drug will not be approved in its current form.
Qnexa, an oral, once-a-day drug is indicated for the treatment of obesity in patients who are obese or overweight and who have comorbidities including hypertension, type 2 diabetes, dyslipidemia or central adiposity. If the drug was approved, it would be a schedule IV drug because of its phentermine component.
According to Mountain View, Calif.-based Vivus, the FDA asked the company to provide an assessment of the drug's teratogenic potential in pregnant women. Additionally, the agency asked the company to provide evidence that the drug will not increase a patient's risk for adverse cardiovascular (CV) events.
A 2008 trial conducted by Vivus showed that Qnexa decreased the risk of CV events in type 2 diabetic patients when compared to placebo. Patients administered the drug saw drops in systolic blood pressure, diastolic blood pressure, fasting plasma glucose and triglyceride levels.
The agency also requested that the results of the SEQUEL study, which was a substudy of the 675 patient, 56-week CONQUER study, be submitted. The FDA said it has the right to further comment on the drug’s proposed labeling and mandated that the company notify the FDA of any new safety updates or adverse events associated with the drug.
Vivus said that it will compile an analysis of existing data to demonstrate that the drug does not increase CV events in patients.
The FDA's decision regarding Qnexa comes on the heels of another controversy surrounding the obesity drug sibutramine (Meridia, Abbott) after results of the SCOUT trial showed that the drug may lead to increased cardiac events in patients. After a push from the FDA, Abbott voluntarily removed Meridia from the U.S. shelves, despite saying that "sibutramine has a positive risk/benefit profile in the approved patient population."
A week later, Meridia was also pulled from the Canadian market.
Qnexa, an oral, once-a-day drug is indicated for the treatment of obesity in patients who are obese or overweight and who have comorbidities including hypertension, type 2 diabetes, dyslipidemia or central adiposity. If the drug was approved, it would be a schedule IV drug because of its phentermine component.
According to Mountain View, Calif.-based Vivus, the FDA asked the company to provide an assessment of the drug's teratogenic potential in pregnant women. Additionally, the agency asked the company to provide evidence that the drug will not increase a patient's risk for adverse cardiovascular (CV) events.
A 2008 trial conducted by Vivus showed that Qnexa decreased the risk of CV events in type 2 diabetic patients when compared to placebo. Patients administered the drug saw drops in systolic blood pressure, diastolic blood pressure, fasting plasma glucose and triglyceride levels.
The agency also requested that the results of the SEQUEL study, which was a substudy of the 675 patient, 56-week CONQUER study, be submitted. The FDA said it has the right to further comment on the drug’s proposed labeling and mandated that the company notify the FDA of any new safety updates or adverse events associated with the drug.
Vivus said that it will compile an analysis of existing data to demonstrate that the drug does not increase CV events in patients.
The FDA's decision regarding Qnexa comes on the heels of another controversy surrounding the obesity drug sibutramine (Meridia, Abbott) after results of the SCOUT trial showed that the drug may lead to increased cardiac events in patients. After a push from the FDA, Abbott voluntarily removed Meridia from the U.S. shelves, despite saying that "sibutramine has a positive risk/benefit profile in the approved patient population."
A week later, Meridia was also pulled from the Canadian market.