June 28, 2022

FDA Rejects Another Weight Loss Pill

diet weight loss pills

The FDA is making it hard on weight loss pill applications. They've already denied three applications this month alone.

Last week the FDA rejected the weight loss pill lorcaserin. This week they have rejected Vivus Inc.’s drug, Qnexa. This represents quite a setback for those trying to get a handle on obesity in America. This is also the third weight loss pill to be rejected this month.

In July, a panel of experts had voted 10-6 against Qnexa, so the FDA wasn’t expected to approve the drug. This is despite it being shown to be effective in over weight and obese patients. The patients lost, on average, 6% to 10% of their body weight while in the clinical trial.

One panel member did say that the drug was far superior to anything else that was on the market, but there continues to be concerns over cardiovascular and psychiatric issues.

According to Dr. Ken Jujioka, the director of the center for weight management at the Scripps Clinic in San Diego, “It looks pretty bleak out there for anyone trying to get a drug approval for weight loss.”

The company remains confident with the safety and the efficacy of Qnexa, as was demonstrated in the clinical trial. They will continue to work with the FDA in hopes of an approval for the treatment of obesity. Leland Wilson, chief executive officer of Vivus said they will work on a response that they can present to the FDA in about six weeks.

There is still one more obesity treatment that is pending an FDA decision, Orexigen Therapeutics Inc.’s Contrave.