Diet Drug Study Crashes And Burns In The Wake Of Leaked Results Reply

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early interim analysis of the study.

The news about the trial was announced in a press release from the companies and a press release from the Cleveland Clinic, the home institution of Steve Nissen, the trial’s chairman.

Click here to read the full post on Forbes.

 

Previous Coverage:

Steven Nissen (AP Photo/Judi Bottoni)

Advertisements

FDA Approves Another New Weight Loss Drug 1

The US FDA today approved a new weight loss drug that will be called Qsymia,the brand name for the combination of two previously approved drugs, phentermine and extended-release topiramate. The drug is manufactured by Vivus, Inc.

In a press release, the FDA said Qsymia had been approved for use in obese adults (BMI of 30 or above) or in overweight adults (BMI of 27 or above) with at least one other weight-related condition such as hypertension, diabetes, or dyslipidemia.

The label recommends a daily dose of Qsymia containing 7.5 mg of phentermine and 46 mg of extended-release topiramate. The drug will also be available at the higher dose of  15 mg of phentermine and 92 mg of extended-release topiramate.

According to the FDA, in clinical trials, at one year, patients taking the recommended dose had an average weight loss of 6.7%, while patients taking the higher dose had an average weight loss of 8.9%, when compared to patients taking placebo. People taking the lower dose of Qsymia who do not lose 3% of their body weight after 12 weeks are unlikely to achieve a sustained weight loss on the same dose. These patients should either discontinue the drug or move to the higher dose. After 12 weeks on the higher dose, people  who do not achieve a 5% weight loss should discontinue the drug.

The combination drug is contraindicated during pregnancy. Because of the high risk of oral clefts in fetuses exposed to topiramate, women should have a negative pregnancy test before starting Qsymia and every month while taking the drug, in addition to using contraception. The drug is also contraindicated in people with glaucoma or hyperthyroidism. Because the drug may increase heart rate, its use in people with recent unstable heart disease or stroke is not recommended. In addition, the FDA recommends that all patients taking Qsymia have their heart rate monitored regularly, in particular when starting the drug or increasing the dose.

FDA is requiring Vivus to implement a Risk Evaluation and Mitigation Strategy (REMS), consisting of a Medication Guide for patients and a plan to educate prescribers and patients to avoid the increased risk of birth defects associated with the drug. Pharmacies will need to obtain a special certification before dispensing Qsymia. The FDA is requiring the company to perform a long-term cardiovascular outcomes trial.

The drug had previously been known as Qnexa, but was forced to change the name by the FDA “because too many other drugs ended in the same letters and it would have caused confusion,” Vivus President Peter Tam told Bloomberg News.

The approval of Qsymia, along with the approval a few weeks ago of Arena’s lorcaserin (Belviq), are the first new weight loss drugs approved by the FDA since 1999.
Click here to read the FDA press release…

FDA Advisory Panel Gives Green Light to Qnexa Diet Pill 2

Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of  phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this would have to be completed prior to approval.

Birth defects associated with Qnexa were another source of concern. The panel expressed strong support for a risk evaluation and mitigation strategy (REMS) to accompany any approval. But the panel ultimately was impressed by data showing a 10% weight loss at two years for people taking the drug.

“Of all the obesity drugs, this one has the highest efficacy in terms of weight loss, so that shifts the balance in terms of requiring a post-approval study rather than a pre- approval study,” panel member Sanjay Kaul told Bloomberg News.

Kaul told CardioBrief that the 20-2 vote appears more enthusiastic than the actual sentiment of the panel. Panel members remain concerned about the uncertainty regarding cardiovascular risk of the drug, including the possible adverse effects on blood pressure and heart rate. Kaul said the panel was impressed by the company’s proposed REMS, but that there is little evidence demonstrating that even a strong REMS can significantly reduce adverse outcomes like birth defects.

Two other diet drugs, Contrave, the combination of naltrexone and bupropion, from Orexigen, and locaserin, from Arena, have been struggling to gain FDA approval in recent years. No new diet drug has been approved for marketing in the United States since 1999.