Saturday, November 17, 2012

A Look at Qsymia

The FDA has approved several obesity drugs over the past sixty years. Some of the drugs were approved for short term use, and some were approved for use long term. Some of these drugs were found to have serious side effects, and taken off the market. Two new drugs, Belviq and Qsymia, were approved by the FDA in 2012. While Belviq is expected to be available in 2013, Qsymia is currently on the market. Although Qsymia received a good deal of attention leading up to its FDA approval, market results, so far, have been disappointing.

Qsymia is a combination of two existing FDA approved drugs. Those drugs are Topiramate and Phentermine. Topiramate, originally produced by Johnson and Johnson, was approved by the FDA in 1996. Topiramate is mostly used to treat seizures. Topiramate is sold under the brand name, Topamax, by New Jersey based Ortho McNeil Neurologics.

Phentermine  was approved in 1959 as a short term (a few weeks or a few months) treatment for obesity. Phentermine is sold by Medeva Pharmaceuticals under the brand name Ionamin®, and by Gates Pharmaceuticals, under the brand name Adipex-P®. Both Topiramate and Phentermine are also sold in generic forms.

Phentermine has an interesting history. It was part of the infamous obesity combination drug Fen-Phen. The “Fen” in the combination is Fenfluramine. Fenfluramine was approved by the FDA for short term use as an obesity drug in 1973. It was manufactured by American Home Products, now known as Wyeth. While Fen-Phen led to  average weight loss as high as ten percent, the drug also had associated side effects. Fenfluramine was found to cause hypertension and heart valve problems. Fenfluramine was taken off the market in 1997 at the urging of the FDA. Phentermine remained on the market.

As stated above, Qsymia is also a combination obesity drug. And while Qysmia has led to respectable weight loss of “at least five percent … body weight” the FDA has placed restrictions on the drug’s use. Qysmia is not recommended for persons with glaucoma, hyperthyroidism, recent heart disease or stroke.

Even though there are restrictions placed on Qysmia, in the opinion of some, the drug was off to a good start when first released. “Vivus Inc. (VVUS)’s obesity drug Qsymia was covered by health insurers more often than anticipated in its first week on the market, which may help drive sales.”

However, it is felt now that the drug is losing its momentum.  VIVUS recently indicated that "it was concerned by the lack of coverage of Qsymia by insurers, as just 20% of patients are getting reimbursed for the medicine." This may mean that most insurers are not sure that Qsymia's benefits outweigh its risks.

While both Qsymia and Belviq received a lot of attention from those interested in weight loss drugs, Qsymia arguably received the most attention. And while the drug probably won't go the way of Fen-Phen, market results to date are somewhat disappointing. However, these results will likely improve, if the weight loss benefits of the drug are found to outweigh its risks.

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