Obesity has been linked to a growing complex of health conditions including diabetes, coronary heart disease (CHD), metabolic syndrome, diabetes, gout, kidney disease, breast, prostate and ovarian cancer, osteoporosis and depression. The Center for Disease Control (CDC) has found that obesity affects close to 100 million American adults- that is one in three and an increase of more than 57 % since 1991. Being overweight can have a devastating effect on human well-being both physically and emotionally. (Source, Wiki)
Controlling obesity with pharmaceutical drugs is one of the main approaches of the conventional (allopathic) medicine. On December 7, 2010, the advisory committee of the U.S. Food and Drug Administration (FDA) approved with 13- 7 votes a new weight lose pill. The drug is developed by the California based biopharmaceutical company Orexigen Therapeutics, Inc. and holds the name Contrave. It represents a combination of two already approved drugs- the antidepressant Wellbutrin (Bupropion) and Naltrexone, marketed under the trade names Revia and Depade, and used to fight addictions. The drug is expected to be the new slimming pill on the market that awaits for approval in a decade. (Source, Orexigen Inc)
“Contrave is designed to activate a hypothalamic center in the brain associated with reduced appetite, while blocking beta-endorphin, which may be responsible for limiting weight loss. We are also studying the effects of Contrave on related central pathways associated with the rewarding nature of select high calorie foods, ” stated the President and CEO of Orexigen
The expert panel concluded that Contrave is modestly effective and it can cause slight elevation in blood pressure and accelerated pulse. It may also cause dry mouth, constipation, headache, and mild insomnia. “We are encouraged by the panel’s view of the risk-benefit profile of Contrave. We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions rised at the meeting today in preparation for our PDUFA action date in January,” said Michael Narachi, president and CEO of Orexigen.
By following its final non-binding recommendation FDA is advising for another clinical trial in order to assess for long-term heart risks and final decision is expected in January, 2011. The expert FDA panel decision is based on the conclusion that the potential benefits of the new drug outweigh the potential risks when used long-term in a population of overweight and obese individuals.
Earlier this year three different companies (Orexigen, Arena and Vivus) competed for the FDA advisory panel final approval. Recently, the FDA sent a request to Abbott Laboratories in order the drug Meridia to be pulled from the market due to heart problems and temporarily denied its final approval of Qnexa and Lorcaserin over risks of psychiatric, cognitive or cardiovascular issues. The only available weight loss drug sold on the US market is Orlistat (Xenical) – a lipase inhibitor, also approved by the FDA.
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