Vivus Inc. has released a diet pill called Qsymia – one of only two diet pills (the other being Belviq) to be released in the last 13 years. Vivus applied intense pressure on the FDA earlier this year to approve the obesity-targeted drug for for the two-thirds of Americans who have a body fat percentage high enough make them obese.
The problem? Qsymia shares were down 24 percent on Tuesday. Since their launch mid-September, they’ve only seen $41,000 in sales. Analysts were expecting around $310,000 by this point.
Vivus Inc. Chief Commercial Officer Mike Miller stated his concern over the pill’s insurance coverage.
“About 30 percent of patients chose not to fill after receiving a [Qsymia] prescription due to cash outlay,” he said. “The average retail price for the patient for 30 days or the recommended dose is approximately $160. Currently, we’re seeing one out of five [patients] being covered by third-party insurance with an average co-pay of $62.” (more…)
An advisory committee to the Food and Drug Administration decided that obesity drugs must undergo clinical trials to ensure they do not cause heart attacks. The 17 to 6 vote now requires studies for all obesity drugs even if no apparent cardiovascular risk exist.
The track record of weight loss drugs has not been stellar. Though the new testing requirement will require much more time and money and ultimately impede drug production, the majority felt strongly about their decision.
“Given the checkered history of weight loss drugs, I think it is better to be prudent and err on the side of caution,” Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles.
Those who oppose the vote feel a much needed treatment will now be difficult to administer.
“If the F.D.A. follows through with this vote, you’ve just added another big disincentive for the drug companies to come up with obesity drugs, and we desperately need new drugs,” said Dr. Ed J. Hendricks, an obesity specialist in Sacramento.
With the obesity epidemic on a collision course with no stop in sight, the FDA and drug developers are feeling the pressure to approve and develop weight loss drugs at a fast clip. Qnexa could be approved by the FDA by April but some people are wondering how this could happen when it was initially rejected by the FDA advisory committee a couple years ago.
Qnexa, which is a combination drug of phentermine and topiramate, was initially brought to the FDA advisory committee’s attention in 2010. The committee basically told the drug maker Vivus to go back to the drawing board and give them more concrete data about the phentermine portion of Qnexa would not lead to cardiac events like heart attacks even with its side effect of increased blood pressure. The committee also wanted a plan in place to prevent women of childbearing age from being exposed to topiramate’s birth defect potential if they became pregnant while on Qnexa.
If, at first, you don’t succeed try, try again. That’s what Vivus, the makers of a diet drug called Qnexa did by resubmitting their drug approval application to the FDA advisory committee and it is now one step closer to being approved. The initial application was rejected because of two main concerns: risk of cardiac events like heart attacks and risk to women of child bearing age and women who may be pregnant.
Qnexa is a combination drug of phentermine and topiramate. Both these drugs are currently available by prescription which makes the approval process a little bit easier for Qnexa because there already are a lot of clinical trials and data available about these drugs. Phetermine increases metabolism while topiramate is used for seizures, migraine prevention and as an adjunct therapy for conditions like bipolar disorder. Weight loss for topiramate is really more of a glorified side effect that is believed to be caused by an increase in energy for the patient and increased feeling of fullness after eating because the digestive tract is slowed down.
Qnexa is a capsule made up of immediate release phentermine and extended release topiramate which would have a longer duration of action and is taken once daily. Vivus is currently studying the use of a low, moderate and high dose combination. Qnexa is indicated for people who have a BMI of 30 or higher or overweight patients with a BMI greater than 27 who have other conditions like hypertension, type 2 diabetes, high cholesterol, and fat that is most prominent on the abdomen also known as belly fat. The most common side effects of this combination drug include a prickling or tingling sensation, dry mouth, constipation, and headache.
The small pharmaceutical company Vivus is preparing to resubmit its diet pill Qnexa for approval from the FDA, however federal officials still have concerns. The FDA initially rejected the weight loss medication in October of 2010, due to concerns that taking the drug could increase the risk possible birth defects and heart problems.
Qnexa is a drug that combines two existing the appetite suppressant Phentermine and the anti-convulsant Topiramate. Vivus has gone through several rounds of research in the process of resubmitting its request to the FDA, and succeed in lifting the contraindication for women of child-bearing age, although the FDA is still worried about a possible link between Qnexa and cleft lip defects. The drug has also been shown to increase blood pressure and cause higher heart rates in some patients.
The FDA will hold a public meeting on Wednesday with experts to try to resolve these concerns. The panel of doctors will also decided if any additional research is required, and will take a vote on Qnexa’s safety, and the FDA is expected to make its final ruling in April. Vivus will offer to conduct a long-term follow-up study to monitor patients for heart events.