Millions of Americans (myself included) struggle with weight gain, being overweight and with obesity. If the FDA follows the advice of the experts on the Endocrinologic and Metabolic Drugs Advisory Committee today, a new weapon will become available in 2012. Qnexa (a combination of the existing drugs phentermine and controlled release topiramate) was presented to the FDA in July 2010 and was rejected.
Now the manufacturer of the drug (Vivus) brought new information to the FDA Endocrinologic and Metabolic Advisory Committee today along with the same drug and the committee voted 20 to 2 that the medicine should be approved. It’s important to know that the FDA usually, but is not required to follow the guidance of its expert panels. The FDA briefing documents and advisory committee agenda are available at www.fda.gov.
young thin woman An FDA press release will no doubt be forthcoming in the very near future. If it is approved, it could be the first addition to the weight loss category since 1999 and will be profiled in the Essential Guide to Prescription Drugs.
Beyond the recommendation for approval, the FDA expert panel also brought forth a strong recommendation that a large disease and death (morbidity and mortality) study should be started. Similar to other medicines where there are certain benefit to risk questions and potential heart and blood vessel risks (cadriovascular), a risk evaluation and mitigation strategy (REMS) was recommended.
Time will tell if the FDA approves Qnexa this time around. Clearly, the expert panel thinks that the benefits outweigh the risks of Qnexa. Our bulging waists and multiple diabetes and heart disease risk factor profiles desperately need some relief.