Obesity Drugs Struggle Despite an Overwhelming Need
While the news states that the new weight loss medication Contrave will most likely be approved in September 2014, the struggles the drug has faced so far hint about the challenges obesity drugs have had historically in the U.S.
In the last 13 years, only two drugs have been approved by the FDA, including Qsymia and Belviq. Contrave makes number three. With such a widespread obesity problem in the country, the scarcity of effective obesity medications is startling to many people.
Contrave drug manufacturer Orexigen has already attempted to have Contrave approved by the FDA twice: once in 2011, when it was rejected, and again in June 2014, after which they were put on a three-month extension to look at the package inserts more closely. The primary concern was with the cardiovascular risks listed on the packaging.
There are currently more than 110 million people in the U.S. struggling with obesity, numbers which indicate a growing need for obesity medications. However, weight loss drug manufacturers have major hurdles to overcome getting obesity medications developed, approved by regulators and accepted by the public. .
Why Obesity Drugs Suffer
One of the major reasons weight loss drugs struggle so much with approval and acceptance is because of the limited benefits they offer compared to their risk of serious side effects. While many people taking diet drugs do lose weight, the results are relatively modest and short lived. Without lifestyle modification, weight usually returns as soon as the medication is stopped. However, weight loss medications are powerful drugs with the possibility of significant side effects.
Historically, other weight loss drugs such as Fen-Phen, caused heart valve damage and even death. This high risk to benefit ratio leaves the FDA reluctant to approve these medications without extensive safety testing.
The last two diet drugs approved by the FDA were Qsymia and Belviq. Qsymia results in about 9 percent excess weight loss, while Belviq has just 3 percent excess weight loss. Contrave is currently between the two at 5 percent. Although these results are sufficient to provide health benefits for obese patients, they are significantly below the 50% to 60% excess weight loss seen with bariatric surgery.
Another concern for both doctors and patients is that these medications can be expensive and insurance rarely covers them. Since in most cases they are not considered required medical treatment, most people end up paying out-of-pocket for them.
Moving Forward with Better Success for Obesity Drugs
The future is still somewhat a mystery in regards to weight loss drugs and how well they will be accepted by consumers. While drugs released into the market initially do well, once the excitement is replaced for the reality of the drugs actual potential for helping a person lose weight, the sales quickly decline.
In order to be successful, a diet drug needs to have less side effects and better benefits for consumers. Even though the release of Contrave suggests higher success for the drug manufacturer, it still promises only moderate short-term weight loss success for patients.