Diabetes and obesity are closely linked, and plenty of diabetics struggle to follow their doctor's orders to lose weight. The biopharmaceutical company Vivus hopes to promote an investigational new drug, Qnexa, as each a weight loss drug and a diabetes medication.
Qnexa is in section three clinical trials to treat obesity, and in section a pair of clinical development for the treatment of sort a pair of diabetes and sleep apnea. the foremost recent clinical trial of Qnexa as a weight loss drug resulted in a mean ten % weight loss in study participants.
Qnexa may be a combination of the appetite suppressant phentermine, (best referred to as the "phen" in fen-phen, a controversial weight loss drug that was achieved the market in 1997), and also the anticonvulsant topiramate, prescribed to treat epilepsy and stop migraine headaches.
Qnexa was denied approval in late 2010, when the FDA expressed considerations a couple of slightly increased risk of adverse psychiatric and cardiovascular events, and questioned the likelihood of birth defects in pregnant ladies taking the drug.
More than 2400 patients took half within the latest study. Study participants were all clinically obese, and conjointly suffered from 2 or a lot of secondary medical conditions like diabetes or heart disease. Patients conjointly saw enhancements 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 % in worth since the most recent study results were released. If approved, Qnexa would be the primary new weight loss drug on the market in additional than 10 years. Currently, the sole FDA approved prescription weight loss drug is orlistat (Zenical). Orlistat prevents the body from absorbing the fat in food, and is thought for unpleasant aspect effects like loose, oily stools, fecal incontinence and flatulence.
A second weight-loss drug manufacturer, Orexigen, is additionally struggling to induce FDA approval for his or her new diet drug, Contrave. Contrave may be a combination of bupropion (the antidepressant Wellbutrin, conjointly marketed because the smoking cessation aid Zyban) and naltrexone, an opiate antagonist prescribed to treat narcotic and alcohol addiction. Contrave is meant to curb food cravings, and proved effective than Qnexa in terms of weight loss.
Contrave passed a significant hurdle in late 2010 when an FDA advisory committee voted 13-7 for its approval, however the FDA disagreed in early 2011, soliciting for a brand 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 considerations outweighed the drug's "marginal effectiveness".
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