Obesity drugs lumber toward marketplace
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About this time last year, we were reporting on the failure of several investigational weight-loss medications. They included Sanofi-Aventis’ rimonabant as well as two other drugs that aimed to work by blocking cannabinoid receptors in the brain.
However, one or more new weight-loss drugs may become available next year, based on research presented this week at the Obesity Society’s annual meeting in Washington, D.C. Xenical was the last prescription weight-loss medication approved by the Food and Drug Administration, in 1999.
An update on the three leading candidates for approval:
- Lorcaserin, made by Arena Pharmaceuticals, reported Phase 3 study results of 4,008 patients who took the medication for one year. Almost half of the patients lost 5% or more of their body weight, and 22.6% lost 10%.
- Qnexa, made by Vivus Inc., is a combination of two drugs: phentermine and topiramate. In two Phase 3 studies of 3,750 patients, the average weight loss was 14.7% of body weight (37 pounds) after 56 weeks.
- Contrave, made by Orexigen Therapeutics Inc., is also a combination of two medications: buproprion SR and naltrexone SR. In a Phase 3 study, one-third of patients lost 10% of body weight.
The manufacturers all reported acceptable safety profiles, but the FDA will be looking closely at that issue. Rimonabant reached late-stage clinical trials before being abandoned because patients reported an increase in depression symptoms and suicidal thoughts.
‘Safety is of paramount importance in treating patients who are overweight or have obesity,’ Dr. Lee Kaplan, an associate professor of medicine at Harvard who presented the data on lorcaserin, said in a news release. ‘We need new therapies that help patients reduce their weight and improve cardiovascular factors such as high blood pressure and cholesterol, while avoiding cardiac toxicity and symptoms of depression.’
-- Shari Roan