#Business Review USA#FDA#FDA Approval#FDA Decision#Food & Drug Administration#Obesity#Qnexa#Vivus#Weight Loss#Weight Loss Drugs

FDA Advisors Reverse Decision on Weight-Loss Drug Qnexa

|Feb 23|magazine6 min read

With the growing problem of obesity in the U.S. hastened by deep-seated roots stemming from a largely sedentary lifestyle and unhealthy eating habits, it’s no surprise that a quick-fix continues to be the elusive carrot on a stick.

Pharmaceutical giants, including Arena Pharmaceuticals, Lorcaserin and Vivus Inc., are jostling for the chance to be the first company to release an FDA-approved prescription weight-loss drug since the last, and only, approved prescription drug of its kind hit the market in 1999.

The search for a “magic pill” has been hindered in recent months as Vivus’ drug, Qnexa, was struck down by the FDA’s advisory committee last year, citing direct connections to heightened risk of cardiovascular problems and birth defects. In an apparent change of heart, a panel of medical experts released a 20-2 vote in favor of Qnexa Wednesday, likely meaning the FDA’s final decision later in the year will be to approve the drug.

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The drug manufacturer, based out of Mountain View, California, addressed the original health concerns by proposing monthly pregnancy tests for patients administered the drug, as well as strictly controlled distribution by registered pharmacies and specialized training for healthcare providers to better educate them on the risks of the medication. Vivus also recommended implementing a program to closely monitor heart risks in patients using the drug.

"We are confident the Qnexa [risk management program] balances the safeguards while allowing access for appropriate patients,” Dr. Barbara Troupin, Vivus' senior director of global medical affairs, told the committee. Qnexa combines the appetite suppressant phentermine and anticonvulsant drug topiramate. Users lost an average of 10% of their body weight during clinical trials.

Over-the-counter weight loss supplements remain popular, despite recalls and negative side effects, including dozens of deaths linked to the Fen Phen craze of the ‘90s. Marketdata projects diet pill and meal replacement sales alone will total $3.04 billion in yearly sales by 2014.