FDA Committee Recommends Approval of Qnexa, a Prescription Weight Loss Drug

More than 78 million Americans over the age of 20 are obese, according to a 2010 survey conducted by the Centers for Disease Control. Many drug companies have attempted to combat the obesity epidemic by developing medications that help people lose weight, but several have fallen short due to safety concerns. In July, the Food and Drug Administration, or FDA, may be approving the first obesity drug in 13 years called Qnexa.

Qnexa was developed by the biopharmaceutical company Vivus. It is a combination drug consisting of two medications already used to promote weight loss, phentermine and topiramate. Phentermine has been used for short-term weight loss since the 1950s and was part of the weight-loss drug known as fen-phen. Topiramate has been on the market for 15 years as the seizure medication known as Topamax. Topiramate is used as an off-label medication for weight loss because of its ability to suppress appetite.

FDA Approval
Vivus submitted their first application for Qnexa for approval as an obesity drug to the FDA in December 2009. The application included the results of two pivotal year long studies that showed significant weight loss in groups of obese individuals treated with Qnexa as compared to those receiving a placebo.
In addition, the studies showed a significant improvement in comorbidities associated with obesity, including diabetes and hypertension, in the people receiving the medication. In February 2012, the FDA’s advisory committee for Qnexa recommended its approval as a treatment for obesity in a vote of 20 to 2. Now Vivus is awaiting a decision on full FDA approval by July 2012.

Investors are closely watching Vivus and the pending approval of Qnexa. In February 2012, after the advisory committee’s approval, Vivus stock rose 98% in its first day of trading. Qnexa is described as the next Lipitor, which is a $10 billion a year earner for Pfizer. As of May 10, 2012, Vivus stock was trading at $23 a share, and after final approval by the FDA it is projected to jump to more than $30 a share. Right now Vivus is considered a hot stock for investors to buy.

Safety Concerns
Before investing in this hot biopharmaceutical company, it is important to know the safety concerns surrounding this new obesity drug. Like many of its predecessors, Qnexa can increase heart rates and cause heart palpitations, which increases risk of heart attack and stroke. In addition, topiramate has been linked to birth defects, causing cleft palates in infants. If approved, Qnexa’s critics fear another disaster similar to fen-phen, which was removed from the market due to heart valve damage in several users and three deaths.

Obesity is a major health concern responsible for the development of numerous chronic illnesses, often resulting in early death. Currently, there are very few successful methods of treatment for obesity aside from invasive surgeries like gastric bypass. Despite safety concerns, drug companies, doctors and the FDA are anxious to find a treatment that will help millions of people lose weight and live a healthier and longer life.

Suzanne Somers

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