FDA Turns Down Weight Loss Drug Qnexa, But Makers See Short Timeline For Approval

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Main Category: Obesity / Weight Loss / Fitness
Also Included In: Regulatory Affairs / Drug Approvals;??Pharma Industry / Biotech Industry;??Diabetes
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Weight-loss drug, Qnexa did not get approval from the FDA (Food and Drug Administration) - for now - but Vivus Inc., the makers of the new drug say they are encouraged by the FDA's Complete Response Letter (CRL) and are sure they can meet the requirements listed in order to get the medication onto the market, probably in 2011. The FDA response did not request any further clinical trials, although it did ask for additional information, which the company believes it can provide from existing data it already has. Vivus said it will file a formal response in approximately six weeks.

Vivus believes approval for Qnexa will come shortly after the filing of its response.

Qnexa is a combination of phentermine, an appetite suppressant as well as a stimulant of the amphetamine and phenethylamine class, and topiramate, an anticonvulsant with weight loss as a side effect. It is an investigational or experimental drug for obesity treatment, as well as related conditions, such as diabetes type 2. In addition, Qnexa lowers blood pressure and blood cholesterol levels.

Obesity drugs have had a bad time getting FDA approval, or even staying on the market for any length of time. Vivus says that after approval it will consider partnering with a large pharmaceutical company to market Qnexa.

Leland Wilson, CEO of VIVUS, said:

We remain confident in the efficacy and safety profile of QNEXA demonstrated in the clinical development program and look forward to continue working with the FDA towards the approval for the treatment of obesity. We are preparing a comprehensive response to the CRL for submission to the FDA in approximately six weeks.

Vivus informs that over 72 million Americans are obese, approximately one third of the country's population. A significantly large number are overweight. People with obesity have a considerably higher risk of developing diabetes type 2, high blood pressure (hypertension), metabolic syndrome, several cancers, a high recurrence of some cancers, osteoarthritis, and cardiovascular disease.

Morbid obesity was found to shorten people's life spans by about ten years, and moderate obesity by 3 years, according to a 2009 article published in the medial journal The Lancet.

An obese individual has built up so much fat that there is an elevated risk of negative effects on their health. Anybody whose bodyweight is 20% higher than it should be, or has a BMI (body mass index) of at least 30 is considered as obese. Exceptions include some weight trainers and competitive athletes who may be heavy, have a high BMI and are not obese or overweight.

Obesity is caused by several different factors, including overeating, lack of physical activity, not sleeping enough, some foods that interfere with lipid metabolism (endocrine disruptors), stress, and a number of medications.

Source: Vivus, FDA

Written by: Christian Nordqvist
Copyright: Medical News Today
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