The FDA stated inside an announcement Monday night which Vivus Inc.'s Qsymia qualifies with regard t...

1. Obesity pill Qsymia gains FDA approval
The FDA stated inside an announcement Monday night which Vivus Inc.'s Qsymia qualifies with
regard to chubby as well as obese those that have no much less than one weight-related well being
problem like substantial blood pressure, type two diabetes or perhaps substantial cholesterol. The
Actual drug is being prescribed inside mixture with a reduced-calorie diet along with exercise.
Weight Problems can be defined as having an appearance mass index (BMI) associated with 30 or
even more, although chubby people are thought as having a BMI - a new ratio of height more than
excess weight - of 27 or perhaps higher.
Phentermine ended up being one-half regarding the favorite Wyeth drug fenfluramine, or fen-phen,
which usually ended up being tied in order to heart valve damage and taken off industry within
1997, resulting inside a $13 billion settlement more than tens involving 1000s of lawsuits.
The FDA mentioned individuals who took Qsymia as well as didn't shed a minimum of 3 % associated
with their own body weight from the twelfth week of treatment are not more most likely to achieve
weight-loss with continued treatment, and could need a higher dose. When those patients don't shed
at least 5 % regarding their weight right after 12 weeks about the higher dose, these people should
stop getting the drug.
The associated Press reviews in which Vivus hopes to end up being able to carry your drug to market
through the fourth quarter involving this year, and also hasn't determined just how much pills will
cost.
"Today's choice from the FDA marks the next time the agency offers approved a brand name new
obesity treatment drug inside the last 30 days," Laurie Traetow, executive director of the American
Society regarding Bariatric Physicians stated in a statement. "Obesity medicine specialists tend to be
excited about the FDA adding yet another device for the weight problems remedy toolbox, that
regarding therefore many many years ended up virtually barren inside the pharmacotherapy area."
Qsymia's approval follows the particular FDA's approval of another obesity pill, Arena

2. Pharmaceuticals' Belviq, throughout late June. that drug has been the really first weight-loss pill
approved from the FDA inside greater than a decade, since Xenical (sold non-prescription as alli)
was approved. Anti-obesity pills face an uphill battle for approval because the drugs usually bring
aspect effects.
"Obesity threatens the general well being involving patients and is actually a main public health
concern," Dr. Janet Woodcock, director with the FDA's Middle regarding Drug Evaluation and also
Research, stated in a statement. "Qsymia, utilized responsibly in mixture using a wholesome lifestyle
that features a new reduced-calorie diet program and also exercise, provides another treatment
method choice for chronic weight management."
(CBS News) Following weeks of anticipation and also deliberation, the particular obesity pill
formerly called Qnexa continues to always be able to be approved through the food and Drug
Administration. the product will be offered beneath a manufacturer new name, Qsymia.
Qsymia is surely an extended-release mixture of a couple of older drugs, phentermine along with
topiramate. Phentermine is definitely an amphetamine approved regarding short-term weight
reduction and topiramate is prescribed to become able to avoid seizures and also migraines, and is
supposed to make pill-takers feel a lot more full.
The drug's safety along with efficacy has been reviewed throughout a pair of studies. That They
showed that after a year of taking the drug, patients lost in between 7 and 9 % of his or her physique
weight, and also between 62 as well as 69 % involving study members lost 5 percent associated with
his or her physique weight, in contrast together with 20 percent associated with patients taking a
placebo.
Different doses regarding Qsymia are generally observed in this image. Vivus Inc.
Vivus Inc.
Back inside February, a new panel regarding advisors for the FDA voted 20-2 in assistance of
approving your drug, however the group stresses that the drugmaker ought to perform follow-up
studies to appear at the pill's results about the heart. Qsymia ended up being formerly rejected by

3. the FDA inside 2010, below the particular name Qnexa, as the drug ended up being tied to elevated
heart rate, psychiatric problems as well as birth defects. Vivus then resubmitted your drug
application together with additional safety data.
Qnexa and the FDA: The explanation why safe diet plan prescription medication is hard to come by
FDA approves weight problems pill Belviq with regard to obese, chubby people that have weight-
related health problems
The most common aspect outcomes of Qsymia were tingling in the hands as well as feet, dizziness,
insomnia, constipation, a alteration of taste sensation and dry mouth. Pregnant women shouldn't
take Qsymia because it could harm your fetus, your FDA said. Your FDA in addition doesn't
recommend the particular drug with regard to patients together with glaucoma as well as
hyperthryoidism, nor patients together with current heart disease as well as stroke, since the actual
drug might also elevate coronary heart rate.
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According in order to government estimates, greater than one-third regarding U.S. adults tend to be
obese.
Vivus had proposed the actual identify Qnexa within the drug's application, nevertheless an FDA
spokesperson told HealthPop inside an e-mail that the drug's title had been subject to review for you
to determine whether there is prospective for confusion together with some other approved drugs,
and the business eventually went together with Qsymia to cut back any potential with regard to
medication errors.