In 2010, more than one-third of U.S. adults (35.7%) are obese. Close to 20% of children and adolescents aged 2-19 years are obese. The combined number of folks defined as obese and overweight in the U.S. makes up a staggering 2/3 of the population.
As a result of this, the prevalance of diabetes, cardiac disease, cancers, and other obesity associated medical conditions has increased in the U.S. At a time where overall healthcare spending costs threaten to break the nation's budget and Medicare spending needs to be brought under sustainable control, corporations that can contribute to the solution of obesity have an opportunity to tap into a potentially huge revenue stream. Unfortunately, long gone are the days of exercise and a low caloric diet - if lifestyle changes alone have worked, our obesity epidemic would not exist today.
These days a common question in my office would be "Doc, do you have a pill to help me lose weight? I've already tried everything else."
It has been over 10 years since a weight loss medication has been approved by the FDA. Since the Fen-Phen debacle, the FDA has been extra vigilant in evaluating weight loss medications seeking approval. Given the gravity of the obesity problem a number of corporations have made recent headlines toward providing a solution to our Obesity Epidemic:
First up to bat is Vivus (VVUS). On February 23, 2012 Vivus received a recommendation from the FDA advisory committee that the FDA approve the company's experimental obesity drug, Qnexa. Qnexa is a low-dose combination of 2 already approved medications on the market - phentermine and topiramate. Phentermine is an appetite suppressant while topiramate is an anti-seizure medication (whose side effect just happens to be weight loss). In clinical trials Vivus reports that 2/3 of their participants taking the highest dose of Qnexa lost 10% of their body weight. Both phentermine and topiramate's side effects are well known, although there may be lingering questions regarding cardiac safety.
How excited is the market with the first potential approved weight loss medication in over 10 years? Vivus' stock price practically doubled in one day on the news of the FDA Advisory Committee Recommendation (see pretty blue line going up). April 17 is the designated FDA Decision Day for Qnexa.
Arena Pharmaceutical (ARNA) is next in line after Qnexa for FDA review. In its Phase III BLOOM-DM trial, Arena's Lorcaserin medication showed that more than 35% of participants lost 5% of their body weight and 10% of participants lost more than 10% of their body weight. HgbA1c (3 month average blood sugar level) decreased by 0.9. Arena's weight loss seems more modest than that of Qnexa although Lorcaserin apparently had more improved diabetes control than that of Qnexa based on HgbA1c comparison. Arena awaits the FDA's Advisory Committee decision on May 10th and an FDA approval decision on June 27th, 2012. Of note is that the FDA originally rejected lorcaserin in 2010 due to concerns that some animal studies indicated potential tumor growth in rats. Since then Arena has ran more studies to address these concerns which will be evaluated by the FDA Advisory Committee on May 10th.
In Conclusion, here are some important future dates to keep an eye on:
- April 17th: FDA Decision on approval (or rejection) of Qnexa
- May 10th: FDA Advisory Committee decision on Lorcaserin
- June 27th: FDA Decision on approval (or rejection) of Lorcaserin
Well ... after a 10+ years absence of new FDA approvals for weight loss medications, 2012 may bring new hope to a vast majority of Americans.