Another weight loss drug set for FDA approval - wave3.com-Louisville News, Weather & Sports

Another weight loss drug set for FDA approval

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Sandy Wilson Sandy Wilson

LOUISVILLE, KY (WAVE) - The Food and Drug Administration could approve a second weight loss drug called Qnexa on Tuesday. This comes on the heels of the approval of Belviq just two weeks ago, the first diet pill approved by the FDA in 13 years.

This will be second time the FDA has voted on whether or not to approve the drug.  It said 'no' two years ago, but mounting research regarding the drug's benefits is giving it a second look.

Dr. David Winslow at Kentucky Medical Research followed patients in one of the initial studies on Qnexa and saw dramatic results in his patients.

Sandy Wilson lost 20 pounds in the 28 week study that helped determine dosage.

"The idea was to give it in lower doses, to be safer and easier to tolerate without side effects," said Dr. Winslow.

Qnexa is a combination drug containing two well know appetite suppressants.  Phentermine has been used for decades.  "That's the good Fen Phen, the one that doesn't cause problems with the heart,"  Dr. Winslow explained, "It's been on the market a long time even after the Fen Phen debacle."

Still early studies show that phentermine does raise heart rate in some patients given high doses, though Winslow says it's minimal.

The other part of Qnexa is a well know seizure and migraine headache drug called Topiramate or better known as Topamax. It too comes with a risk. Women taking the drug while pregnant show an increase risk of delivering a baby with cleft lip.  

"Is there some risk? Yes," said Dr. Winslow, "Are they going to continue to look at it? Yes, but is the benefit quite significant? I think the data points to yes."

As more studies showed significant weight loss in obese patients, on average a 10 percent weight reduction, the FDA decided to give the drug a second look.  

The studies also show that those taking the drug had a three times lower risk of developing diabetes than the study patient taking placebo.  High blood pressure decreased in patients taking the drug as well.

"Pills aren't totally the answer, but for certain groups that certainly have disorders like diabetes, hypertension, so forth, It's at least sort of a start," said Winslow.

Winslow also enrolled patients in another study on Qnexa that look at its impact on sleep apnea. That study will soon be published in the journal 'Sleep.' 

He said along with the pill doctors prescribing will need to work with patients on behavioral modifications including portion control, exercise and nutrition.

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