In July 2010, Vivus’s experimental diet drug Qnexa was rejected by the advisory committee.

That was followed in September 2010 with the FDA advisory committee recommending against the approval of an experimental weight-loss drug Lorcaserin. On the question of whether the benefits of the drug outweigh the risks when used long-term for a population of overweight and obese individuals, 5 committee members voted yes and 9 voted no.

This month, October 2011, drug developer Vivus Inc. has resubmitted an application for its potential weight-loss drug Qnexa to the FDA (Food and Drug Administration).

The resubmission follows an agreement on filing strategy that it reached last month with representatives of the FDA’s Endocrine and Metabolic Division.

Qnexa has been touted by many experts as the most promising weight-loss drug in more than a decade. But the FDA declined to approve it last year and had asked Vivus Inc. to look into the risk of birth defects in women who use Qnexa ingredient topiramate as a migraine treatment.

The company met with the FDA earlier this year to discuss studying existing electronic health care databases to assess birth defects in the children of women who were exposed to topiramate during pregnancy. Vivus has said it agreed with the FDA on the study’s design, goals and eligibility criteria.

The resubmission seeks approval for the treatment of obesity for obese or overweight patients with conditions like hypertension or type 2 diabetes. Proposed labeling for the drug includes a contraindication for women who could potentially become pregnant.

The FDA panel Voted against the Obesity Drug Qnexa yesterday.

The advisory committee voted 10 to 6 against endorsing the weight loss drug Qnexa, signaling heightened concerns for possible health risks associated with a new generation of diet pills.

The F.D.A. is scheduled to decide by late October whether to approve Qnexa. It usually abides by the advice of its advisory committees.

The outcome of the advisory committee meeting on Qnexa could also mean a more difficult time for two other new weight loss drugs that will face advisory committee hearings this year. These are Lorcaserin from Arena Pharmaceuticals and Contrave from Orexigen Therapeutics.

We keep you posted here.

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.

Federal health advisers will scrutinize Vivus’s highly anticipated weight loss drug. Vivus has asked the Food and Drug Administration to approve its experimental drug Qnexa for patients with obesity. A panel of FDA advisers will vote on the safety and effectiveness of Vivus’ drug coming Thursday.

The potential market for an anti-obesity drug estimates into billions. But most prior therapies have been plagued by lackluster results and serious side effects.

Avianda, a previous obesity drug marketed by GlaxoSmithKline, is also under discussion since studies suggested ties to heart attacks.

Qnexa showed weight loss results in clinical trials, with patients losing between 13 percent and 15 percent of their body weight. But the drug also had an high rate of patient dropouts due to side effects, which include memory and concentration problems.

We keep you up-to-date.