Second new weight loss drug is given an FDA seal of approval
18th July 2012
Vivus, Inc. has been given to go ahead to sell a new weight loss medication named ‘Qsymia’ by the US regulators The Food and Drug Administration (FDA). The approval from the FDA comes less than a month after delivering the same decision on another product for weight loss; Arena Pharmaceutical’s Belviq, which was given the go-ahead on June 27. The dual approval by the FDA marks the first time a weight loss product has been certified fit for public use since 1999 when Roche were approved to sell ‘Xenical’. Some financial analysts now predict that Qsymia could generate an impressive $1.2 billion in sales by 2016. The name Qsymia may be unfamiliar to most people as it was first manufactured under the name ‘Qnexa’, and declined by the FDA back in July of 2010 after they decided there were too many risks involved and that these were outweighing the benefits of the drug. Qsymia is an amalgamation of the appetite suppressant phentermine and the antiseizure drug topiramate. The turnaround by the FDA on Qsymia may be partly due to Arena’s efforts to get their drug approved. In October 2010 the FDA declined Belviq and Arena set out to prove that the medication wasn’t as dangerous as the FDA believed it to be. Echocardiograms were carried out on almost 8,000 people to analyse heart-valve function. It was shown that there was no heart abnormalities present in the patient’s taking the medication and Arena have vowed to do six post-marketing studies which will include a long-term cardiovascular trial. To demonstrate the safety of Qsymia, Vivus orchestrated two placebo-controlled trials spanning over a twelve month time period. The studies involved roughly 3,700 overweight and obese patients, some of whom had various health conditions that were linked to their weight. Subjects were instructed to make positive changes to their lifestyle and diet. After the year had passed it was found that on average patients had experienced a weight loss of between 6.7% to 8.9%, depending on the dosage. It is expected that the recommended daily dose of Qsymia will 7.5 mg of phentermine and 46 mg of topiramate extended-release, with a higher dose of 15 mg phentermine and 92 mg of topiramate extended-release for certain patients. However like all medications, some warnings will be issued in regards to who can and cannot take the drug. For starters, the FDA have made it clear that use of the medication will strictly be restricted to those with a body mass index (BMI) of 30 and above, or those with a BMI of 27 or more who also have a health condition that is linked to their weight. This could include high cholesterol, high blood pressure, or diabetes. In addition, pregnant women will not be allowed to take the drug as there has been shown to be a huge risk to harm being caused to the foetus, such as a cleft lip forming or other problems. Patients with glaucoma or hyperthyroidism are also forbidden from taking the drug. As Qsymia can increase heart-rate, it is not advised for people to take it if they have heart disease or a stroke in the previous six months. The next stage for Vivus will be to perform further studies to thoroughly analyse what impact the drug has on cardiac health. With the future releases of Belvic and Qsymia, these are clearly interesting times for the weight loss community. Furthermore, Californian biopharmaceutical company Orexigen Therapeutics, Inc., are currently undergoing clinical trials of its product, Contrave, targeting a 2014 FDA approval date. Keep checking the Medical Specialists Pharmacy website for all the latest news and information about the release dates of all three medications.