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For the first time in 13 years, a new weight -loss pill prescription looks set to hit the US market.
Wednesday, an advisory committee of the Food and Drug Administration (FDA) recommended that the agency approve Qnexa, a combination pill of two existing drugs - Epilepsy Drug drugs topiramate and phentermine appetite suppressant - to facilitate the loss of clinically obese patients weight. The FDA often follows the recommendation of its advisory committees, but are not required to do so; the agency has until April 17 to make a final decision.
20-2 vote by the Panel for approval was a decisive reversal of the decision of a previous panel in 2010, when Qnexa was rejected over concerns of increased heart rate and birth defects. That panel concluded that the benefits of the drug for weight loss do not outweigh its potential risks.
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In clinical trials, Qnexa led to a 10% weight loss over a year, but it has also been linked to a frequency increase heart and birth defects when taken during pregnancy. According to recent studies, one of the components of the pill, topiramate increases the risk of oral clefts of two to five times when taken by pregnant women, the FDA said.
This is why, if approved, the drug's maker, Vivus, carefully restrict its potential health risks. To reduce the risk of birth defects, women of childbearing age who use drugs will be encouraged to use contraception at the same time and to obtain monthly pregnancy tests. Patients will also be asked to stop taking the medication after three months if it does not.
Doctors and health care providers who prescribe the drug will be trained on the risks and benefits of the medication, and the pill will be available only to registered pharmacies, the pharmacists were educated about prescribing particular circumstances of the drug and agreed to ask doctors to respect them.
The drug is targeted at people with a body mass index, or BMI, of 30 or more - clinically obese. Those with a BMI of 27 or more - considered overweight - would also be eligible if they have other health problems related to weight, such as diabetes or sleep apnea
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Qnexa is obviously not for everyone, but with more than 35% of American adults now tipping the scales into obesity, certain experts believe that a new diet drug is greatly needed -. as many have pointed out, there is currently no treatment that bridges the gap between diet and exercise, which does not work for many, and bariatric surgery
"There an urgent need for better pharmacologic options for individual patients with obesity, "Elaine Morrato, assistant professor of health systems management and policy at the University of Colorado and a member of the Advisory Committee of the FDA, said, CBS News. "I believe Qnexa demonstrated a significant efficacy benefit and that there are consequences to not treating obesity."
The need appears quite urgent that the panel voted to approve Qnexa without requiring Vivus to conduct studies on the potential heart risks of the drug prior to approval. instead, the panel urged the company to study once Qnexa is on the market. "of all the drugs against obesity it has the highest efficiency in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre-approval study, "Sanjay Kaul, a professor of cardiology at the David Geffen School of Medicine at UCLA Cedars Sinai Medical Center, told Bloomberg.
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Other panel members are wary of the potential side effects of Qnexa, however, and voted against approval, arguing that other safety studies are needed first. If the agency approve the drug without these data, Dr. Michael Lauer, a committee member and director of Cardiovascular Sciences at the National Heart, Lung and Blood Institute, told the Los Angeles Times "it would be a decision based on hopes, surrogates and suppositions. "
Whether or not Lauer reason, the decision now lies with the FDA. If the agency follows the advice of the expert group, it would be good news for the legions obese Americans who have few other options. Currently, the only other diet drug is available by prescription Xenical, which works by preventing the body from absorbing fat from food (it is also available over the counter in lower doses under the brand name Alli), but is rarely used.
Qnexa could fill a crucial need. As Joe Nadglowski, President and CEO of Obesity Action Coalition, a group of patient advocacy, told WebMD: it is
Alice Park is a "significant gap Weight of treatment Watchers [bariatric] surgery. " writer at TIME. Find her on Twitter at @aliceparkny. You can also continue the discussion on TIME's Facebook page and on Twitter at @TIME.
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