Yesterday I reported on Arena Pharmaceutical's Belviq, but hinted that two potentially "better" obesity pills were yet to come. Well, no soon after posting that blog, the Food and Drug Administration approved Vivus' Qsymia (pronounced cue-SIM-ee-uh, formerly Qnexa). Studies showed that an average loss of 14.7% (37 pounds) was achieved by obese patients, which is about three times that of Belviq.
The stock for Vivus (VVUS) increased about 10% today:
That latest jump on February 22 occurred because FDA advisors recommended on a 20:2 vote to approve this treatment.
What is Qsymia and what does it do? Well, it is a combination of phentermine (a stimulant) and topiramate (an anticonvulsant--something that prevents seizures). The combo lowers blood pressure and cholesterol, while suppressing your appetite.
Frankly, I'm a bit concerned. For one, in 2010 the FDA said no due to worries abut suicidal thoughts, heart palpitations, memory lapses and birth defects. So Vivus at the request of the FDA (because it sounded too close to another drug name) changed the name from Qnexa to Qsymia and the pill was approved. I'm joking, but not much. If you read my blog yesterday, you also would have noticed that the FDA banned fen-phen in 1997. To quote:
The diet pills were Pondimin and Redux, while the stimulant, Phentermine, put patients in a better mood to stick to this mix.
Well, this that same phentermine with a different diet pill. Remember, fen-phen has 50,000 pending lawsuits.
Anyway, Qsymia will be available this fall in varying strengths. The requirements are the same as Belviq. You need to have a BMI of 30 unless you have a weight related condition, where a 27 will gain you approval from a doctor. Oh, by the way, as I hinted that Belviq looks like Viagra, you can't take the former if you use any erectile dysfunction medication, and, it seems that you should not drive on immediate swallow for it slows your thinking. Carrying this discussion even further, Vivus also received approval for Stendra in April, the first new erectile dysfunction drug in a decade. I can see the ads: IT WORKS IN 15 MINUTES. I read that Viagra takes an hour. Stendra had zero effect on the stock value of Vivus, except to strengthen its position over time.
There will be early restrictions in that doctors cannot provide Qsymia and only specialized pharmacies will be allowed to sell them. Mail orders will be possible. Cosmetic use just to drop a few pounds will be discouraged.
It is said that Belviq is a less risky treatment, but not as effective, if you don't mind that olfactory factor. However, somebody must know something, as Vivus increased 10% today while Arena dropped almost 10%. That third competitor, Orexigen Therapeutics (OREX, their pill is called Contrave, and although not yet approved, will not be sold until 2014) lost 3%.
All these pills will probably cost in the range of $6, but two questions remain. Do you need more than one per day, and the key one, will medical plans pay for them? The general answer is NO! HMSA (if you live in Hawaii) does not cover ANY obesity pill.
It is said that Belviq is a less risky treatment, but not as effective, if you don't mind that olfactory factor. However, somebody must know something, as Vivus increased 10% today while Arena dropped almost 10%. That third competitor, Orexigen Therapeutics (OREX, their pill is called Contrave, and although not yet approved, will not be sold until 2014) lost 3%.
All these pills will probably cost in the range of $6, but two questions remain. Do you need more than one per day, and the key one, will medical plans pay for them? The general answer is NO! HMSA (if you live in Hawaii) does not cover ANY obesity pill.
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