A “diet pill” called Qnexa, which was previously rejected on safety grounds, has been granted safe passage through to the next review stage.
During this week the Digital Journal ran a news item about a controversial “diet pill” called Qnexa. The article outlined that the pill, which contains an amphetamine, had been rejected by the FDA on medical grounds in 2010. The article went on to state that the manufacturer, Vivus, was resubmitting an application for review by an FDA advisory committee consisting of medics.
In a follow up to this story, the panel of advisers to the Food and Drug Administration met on February 22. This time the panel have overwhelmingly backed approval of the anti-obesity pill.
The first time around the panel rejected the pill by 10 votes to 6. This time, the panel was expanded to 22 physicians and this included 12 of the original 16 panel members. This was to provide a wider perspective on the issue.
The Slatest notes that although the pills produced impressive results in clinical tests involving over 4,000 people (leading to an average 10% weight loss for each person), there are risks for those with weak hearts and for expectant mothers. The main side-effects are that the pills increase the heart rate and cause heart palpitations.
According to CBS News, at the end of a debate on the pros, cons and risks associated with the diet pill, the physicians voted 20-2 in favor of the pills being granted a license for sale as an over-the-counter medicine. One of the medics, Dr. Elaine Morrato, of the University of Colorado, is quoted by the New York Times as saying: "There is an urgent need for better pharmacologic options for individual patients with obesity. I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."
The medics did offer a stipulation, which was that Vivus need to conduct a further study of the pill's effects on the heart.
This will represent good news to those concerned about rising obesity in the USA (like the Center for Disease Control) and for the company, which could potentially make multi-million dollar profits (the LA Times notes that Qnexa is the first diet pill to be approved at this stage for more than a decade and Bloomberg estimates that the drug could generate around $450 million in sales by 2015 if it is approved.). For those concerned about the health risks, the news will be less welcome.
The advisory panel do not make the final decision as the FDA itself will need to decide whether to allow the product to be sold to US consumers. That said, it is customary for the FDA to follow medical advice. So, the pills could be available as a prescription only medicine within the year.