Weight Loss Pill from Orexigen under FDA Scrutiny

For decades now, doctors and health care providers have been eagerly awaiting safe and efficient weight-loss therapies. Numerous drugs have been launched so far and rejected by the FDA as they failed to meet the agency’s criteria. Qnexa from Vivus Inc., and lorcaserin from Arena Pharmaceuticals Inc., are among the list of drugs that failed to gain FDA approval in recent times.  Drug trials linked these drugs to potential heart problems, birth defects and cancerous tumors. Earlier this year, Meridia weight loss pill from the Abbott Laboratories stable was also recalled from the market after regulators said it increased the risk of heart attack and stroke.

Contrave

Recently, another drug, Contrave from Orexigen Therapeutics Inc., came under FDA scrutiny. Contrave is a combination of the antidepressant, bupropion and the anti-addiction drug, naltrexone, both of which are associated with side effects like high blood pressure, dizziness and insomnia. Contrave helped patients lose weight, but failed to meet all the criteria set forth by the agency. FDA also raised questions about the pill's effects on the heart. Contrave is the third weight loss pill to be reviewed by the FDA this year. Studies conducted by Orexigen showed that patients taking Contrave lost, on an average, 4.2 percent more weight than patients taking a placebo.

The results did not meet the FDA, 2007 draft Guidelines {Food and Drug Administration (FDA): Guidance for Industry Developing Products for Weight Management, 14th February 2007} which state that there should be at least a 5 percent difference in weight loss between the groups. Further, the drug trial involved a few elderly patients or patients with a history of heart disease, making it difficult to determine the drug's safety in patients at risk for heart attack and stroke. However, the drug did meet the FDA criteria in terms of the number of patients that should lose 5% or more of their weight. FDA has decided to deliberate further, after a panel of experts votes on the drug's efficacy and safety.

The Approval Process for Drugs

American consumers benefit from gaining access to the safest and most advanced pharmaceutical system in the world. The main patrol system regulating the release of drugs into the market is the U.S FDA's Center for Drug Evaluation and Research (CDER). The center evaluates new drugs before they can be sold. Drug companies send the evidence collected from tests to CDER to prove that their drugs are safe and effective for the intended use. A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the company's data and proposed labeling. If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale.

Source:

http://www.pharmpro.com/News/FeedsAP/2010/12/fda-scrutinizes-weight-loss-pill-from-orexigen/

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm

http://www.fda.gov/cder/guidance/7544dft.pdf