VIVUS Says Decision On Approval Of Qnexa Is Pending

Date: Jun-05-2012Qnexa is an investigational drug, taken orally for the treatment of obesity. In April this year, Vivus Inc., its manufacturer, submitted its response to the Day 180 List of Outstanding Issues. European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has scheduled an oral hearing in regards to the drug for September this year, and the CHMP opinion on Qnexa is expected to be released shortly after the meeting.

Peter Tam, president of VIVUS said that :

"We appreciate the flexibility of the CHMP to work with us on the timing of the oral hearing and the scheduling in September ... We look forward to presenting to the CHMP in September, but are currently focused on working with the FDA ahead of the July 17, 2012 PDUFA and the potential Qnexa launch in the U.S. in the second half of this year."

Meanwhile, in the US, Vivus said it is focusing on working with the US Food and Drug Administration in the run up to its July 17th meeting. Vivus said it expects approval of the drug and plans to begin full marketing of the drug in the later part of 2012. Qnexa is one of three obesity drugs pending approval, after the FDA initially rejected them, on grounds of harmful side effects, such as heart problems.

Obesity is seen as being one of the most pressing public health issues with incidence rising rapidly over the last decade and projected to accelerate into the future. Obesity causes all manner of health problems for sufferers, including early onset type two diabetes, cardiovascular problems and general loss of quality of life.

Qnexa [kyoo-nek-suh] was developed to address weight loss, type 2 diabetes and obstructive sleep apnea. Qnexa is taken once-a-day as a controlled-release formulation of low-dose phentermine and topiramate. These drugs are designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior.

In Phase 2 and Phase 3 clinical data to date, patients taking Qnexa have demonstrated statistically significant weight loss, better glycemic control, and improvement in cardiovascular risk factors when they used the drug in combination with a diet and lifestyle modification program.

Written by Rupert Shepherd

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