Diabetes and obesity are closely linked, and many diabetics struggle to follow their doctor's orders to lose weight. The biopharmaceutical company Vivus hopes to market an investigational new drug, Qnexa, as both a weight loss drug and a diabetes medication.
Qnexa is in phase 3 clinical trials to treat obesity, and in phase 2 clinical development for the treatment of type 2 diabetes and sleep apnea. The most recent clinical trial of Qnexa as a weight loss drug resulted in an average 10 percent weight loss in study participants.
Qnexa is a combination of the appetite suppressant phentermine, (best known as the "phen" in fen-phen, a controversial weight loss drug that was pulled off the market in 1997), and the anticonvulsant topiramate, prescribed to treat epilepsy and prevent migraine headaches.
Qnexa was denied approval in late 2010, when the FDA expressed concerns about a slightly increased risk of adverse psychiatric and cardiovascular events, and questioned the possibility of birth defects in pregnant women taking the drug.
More than 2400 patients took part in the latest study. Study participants were all clinically obese, and also suffered from two or more secondary medical conditions such as diabetes or heart disease. Patients also saw improvements in high blood pressure, cholesterol and A1C levels (glycated hemoglobin). High A1C levels indicate high levels of blood glucose in diabetics.
Shares of Vivus have increased up to sixteen percent in value since the latest study results were released. If approved, Qnexa would be the first new weight loss drug on the market in more than ten years. Currently, the only FDA approved prescription weight loss drug is orlistat (Zenical). Orlistat prevents the body from absorbing the fat in food, and is known for unpleasant side effects such as loose, oily stools, fecal incontinence and flatulence.
A second weight-loss drug manufacturer, Orexigen, is also struggling to get FDA approval for their new diet drug, Contrave. Contrave is a combination of bupropion (the antidepressant Wellbutrin, also marketed as the smoking cessation aid Zyban) and naltrexone, an opiate antagonist prescribed to treat narcotic and alcohol addiction. Contrave is designed to curb food cravings, and proved effective than Qnexa in terms of weight loss.
Contrave passed a major hurdle in late 2010 when an FDA advisory committee voted 13-7 for its approval, but the FDA disagreed in early 2011, asking for a new clinical trial evaluating the drug's cardiovascular risks.
Arena Pharmaceutical's Lorcaserin was the third diet drug to fail to win FDA approval in 2010, when the FDA deemed that safety concerns outweighed the drug's "marginal effectiveness".
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