A weight-loss pill from Vivus Inc. has become the first such drug recommended for approval by the FDA in more than 13 years. An advisory panel voted in favor of approving the pill, known as Qnexa, by a margin of 20-2 on Wednesday, according to MSNBC. The FDA has until April 17 to formally approve Qnexa for use in the United States.
What is Qnexa, and what is it supposed to do?
Qnexa is a combination prescription pill that merges the effects of two medications already on the market, according to the Los Angeles Times. It uses both an anti-seizure medication, known as topiramate, and phentermine, an appetite suppressant to promote weight loss. In trials, participants lost an average of 10 percent of their body weight during their first year with the drug, when combined with dietary and lifestyle changes.
According to a press release by Vivus on Wednesday, Qnexa is also being reviewed for its effects on obstructed sleep apnea and type 2 diabetes. The company says that the drug's efficacy in regards to weight loss is tied in to its ability to both suppress one's appetite and increase a person's feeling of "satiety," to make them feel full and halt the inclination to eat more food.
The FDA voted against approval of Qnexa in 2010, what changed?
The FDA has ongoing concerns about the cardiovascular risks of weight-loss pills. Vivus Inc. was unable to provide enough statistical evidence last time around to prove that Qnexa was safe.
Even with the drug's likely approval, the FDA and its regulators are considering some restrictions on Qnexa, such as limited supply and targeted use. In addition, Bloomberg reports that Vivus may be required (and has volunteered) to conduct ongoing cardiovascular trials even after Qnexa's approval, to ensure the long-term safety of the pill.
How easy will a prescription for Qnexa be to get?
The Los Angeles Times states that the pill will most likely have a restricted supply and be difficult for many to get. Possible restrictions that seem likely, and that Vivus itself has encouraged, include making the drug only available through mail-order pharmaceutical outlets. This would in theory make the drug harder to get ahold of illegally or through easy-access channels like online purchasing.
There will also likely be a guideline or restriction regarding just how overweight a person must be before they can be prescribed the drug. The expected threshold will likely be a body mass index (BMI) of 30 or above, although a BMI of 27 with the presence of co-morbid health issues may also be considered. A BMI of 30 or above is enough for a person to be considered obese.
Vanessa Evans is a musician and freelance writer based in Michigan, with a lifelong interest in health and nutrition issues.
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