Obesity medication delayed.
MOUNTAIN VIEW, Calif. -- Vivus Inc. has confirmed that it has been advised by the Food and Drug Administration that the regulatory agency will require additional time to issue a decision on the biopharmaceutical manufacturer's obesity medication Qnexa.
If approved by the FDA, Qnexa could emerge as the first new prescription weight loss pill to reach the market in more than a decade.
Vivus said the FDA pushed back its target date to July 17 to consider a new drug safety plan submitted by the company.
The agency had been scheduled to make a decision by April 17. Vivus said the three-month extension is considered standard when companies submit additional risk management information for a drug.
The FDA has rejected three experimental drugs for obesity in the last three years, including Qnexa, raising questions about whether any new weight loss drugs might win approval. The agency has not approved a new prescription diet pill since 1999.
An effective and safe diet pill would likely be a blockbuster product in the United States, which has an estimated 75 million obese adults and a national obesity rate approaching 35%.
Qnexa was rejected by regulators about two years ago amid concerns that it can cause heart palpitations and birth defects if taken by pregnant women.
But the California-based company resubmitted the drug and it received a positive (20 to 2) vote from a panel of medical advisers in February.
The group emphasized the drug's benefits, which are said to include weight loss of nearly 10% for most patients taking the medication over a year--the highest reduction reported with any recent diet pill.
Still, agency panelists stressed that Vivus should be required to conduct a large follow-up study of the pill's heart effects to assure its safety.
Vivus said it submitted new materials for Qnexa's risk management plan to the FDA in early April. Such plans often include materials such as patient brochures that explain a drug's safety risks.
Side effects reported with Qnexa include birth defects, heart palpitations, suicidal thoughts and memory lapses. Vivus has asked the FDA to approve Qnexa for patients who are obese and who have related health problems such as high blood pressure or type 2 diabetes.
Qnexa is actually a combination of two older drugs that have long been available: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an antiseizure drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite and topiramate is believed to make patients feel more satiated.
Although several drugs are available for short-term weight loss, there is only one FDA-approved prescription drug for long-term weight loss: Xenical from Roche Holdings. But Xenical is seldom prescribed, because it has unpleasant digestive side effects and it achieves only modest weight loss.
Health care experts say that the challenge of weight loss drug development rests in safely turning off one of the body's fundamental directives --to eat sufficient amounts of food to maintain its current weight.
The prolonged long search for an effective diet drug has been marked by repeated failures.
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|Publication:||Chain Drug Review|
|Date:||Apr 23, 2012|
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