Qnexa – Weight Loss Drug FDA Approval?
All signs are that Qnexa weight loss drug receives FDA approval tomorrow.
According to a report released today by the U.S. Food and Drug Administration, a potential new obesity drug appears effective at helping patients lose weight.
There are concerns about side effects — which could include depression, anxiety, impact on heart rate and risks for pregnant women.
FDA advisory committee meeting scheduled for Thursday, could open the door toward FDA approval for the drug which would be marketed as Qnexa.
in trials participants taking Qnexa lost significantly more weight than those taking a placebo, and those taking the highest doses of the drug lost the most weight.
The FDA report can be read HERE (PDF file)
The potential market for drugmaker Vivus’ experimental Qnexa is huge. More than two-thirds of American adults are overweight or obese. Vivus wants to market Qnexa for adults to use along with diet and exercise. FDA staff reviewers said Qnexa clearly helped people shed pounds but pointed to possible side-effect issues, such as the impact on heart rate, depression and pregnancy.
In the report weight loss averaged 3.2%, 6.7% and 8.9% from body weight over the placedo group for the low, mid and high dose of the Qnexa drug.
We keep you updated on the outcome.
Tagged with: FDA approval • Obesity Drug • Qnexa • Weight Loss Drug
Filed under: Weight Loss Drugs
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