FDA is evaluating three new diet pills

The US Food and Drug Administration (FDA) has set the deadline for its advisory committee to evaluate three new diet pills before the end of this year, and the decision on two of them will be given within the next two months.

Qnexa

Qnexa, developed by Canada's Vivus, is a fixed-dose combination of the appetite suppressant phentermine and the anti-epileptic drug topiramate for appetite control and satiety.

On July 15th, the FDA's Endocrine and Metabolic Drugs Advisory Committee held a meeting to assess the pros and cons of the drug. Finally, based on 106 votes, the potential side effects of the drug were greater than potential benefits.

This does not mean that the drug is not effective in clinical trials. In contrast, subjects who took the highest dose for one year lost an average of 10.6%, while those who took a placebo had a decrease of 1.7%; those who took a moderate dose lost 8.4%, while those who took a lower dose lost 5.1%.

The FDA advisory board focuses on the safety of hundreds of thousands of people taking long-term medication for weight loss. Concerns include psychiatric issues such as depression, anxiety, and suicidal thoughts; cognitive side effects, including memory Damage; adverse cardiovascular effects such as increased heart rate, palpitations, metabolic acidosis, and potential birth defects.

When evaluating whether to approve the drug, FDA faced tough choices. Although the side effects of the drug are worrying, the same is true for the health risks caused by obesity.

The FDA will decide whether to approve the drug by October 28 this year.

Chlorophylline

American Arena Pharmaceuticals is waiting for the approval of its appetite suppressant lorcaserin hydrochloride. The drug is a new compound, not a combination of existing approved drugs. This is different from the other two diet pills that are being evaluated.

Arena Pharmaceuticals listed the drug for the drug in July this year with Japan's Eisai Corporation. If the drug is approved, it will receive Eisai’s net sales of more than a third and a payment of up to US$1.37 billion.

The FDA advisory board will discuss the drug on September 16 this year, and October 22 is the deadline for deciding whether to approve it.

Contrave

Contrave, developed by Orexigen, USA, is a compound sustained-release preparation of antidepressant naltrexone and bupropion for the treatment of alcohol and drug addiction. The drug is designed to control metabolism and eating habits.

The FDA advisory board will evaluate the drug on December 7 this year and the deadline for approval is January 31, 2011.