Vivus, Inc. (NASDAQ:VVUS) is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigation product in clinical development for the treatment of obesity, Qnexa® is now called Qsymia - with the first of more than a reported dozen-odd names submitted to the FDA being rejected. Qnexa, now called Qsymia, was approved by US regulators yesterday.
The market for prescription weight loss pharmacotherapy is estimated to be $5 billion by 2015. The potential for new prescription drugs to treat obesity and maintain weight loss is enormous to say the least. In the US, about $60 billion is spent every year on weight loss products, including multiple diet programs, dietary foods and beverages, OTC supplements, appetite suppressants, gym memberships, videos, books, exercise equipment, and even bariatric surgery. There is currently one FDA approved drug for weight loss Xenical (orlistat), but unpleasant GI side effects has resulted in very low popularity.
Qsymia may have the potential, on this approval, to garner a substantial share of this market and even more upon EU approval down the road. Earlier, Vivus' weight-loss drug was rejected by the FDA and received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. Vivus is also in clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS received FDA approval in April 2012 for ED drug avanafil, a PDE5 inhibitor being used for the treatment of erectile dysfunction.
Qsymia was developed by Dr. Thomas Najarian, who is also the inventor of Qsymia. Dr. Najarian opened a weight-loss clinic in 2001 and has seen great success by engaging through a regulatory loophole of sorts, whereby many obesity doctors prescribe the two already approved separate drugs that make up Qsymia. When taken together, they are essentially the same medicine. So, the combination of these two existing drugs, phentermine, an appetite suppressor, and topiramate, a drug typically used for epilepsy and migraines is currently found to be working, and has done so for several years. Some doctors believe the component drugs are very effective at managing obesity, and the two drugs can be prescribed separately to patients under this loophole despite the dangers cited by the FDA.
However, the FDA initially had concerns about the documented side effects of Qsymia, and as a result, the FDA says that Vivus will be required to conduct 10 postmarketing requirements, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.
The most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth.
October 17, 2011: Vivus announced that the company has resubmitted the New Drug Application (NDA) for Qsymia® (diet drug) to the U.S. Food and Drug Administration (FDA). The resubmission follows an agreement reached in September 2011 with officials of the Endocrine and Metabolic Division of the FDA on the filing strategy for Qsymia. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI > 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qsymia includes a contraindication (Not to be used) for women of childbearing potential (WOCBP). The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
After further discussion with the agency, FDA has asked and Vivus agreed to remove the contraindication for WOCBP because a contraindication typically indicates that a drug should not be used in that population because of the risk of use clearly outweighs any possible therapeutic benefit. In addition, FDA asked that Vivus include less restrictive elements in its REMS program that focus on patient and physician educational measures because it was concerned that more restrictive measures may result in greater off-label use of currently marketed topiramate and phentermine products to treat obesity in WOCBP without the benefit of an appropriate risk mitigation program. In response to these concerns, Vivus removed the contraindication in WOCBP and modified its risk mitigation strategy.
February 22, 2012: The panel of doctors took a final vote on whether the drug appears safe and effective. The AdComm ruling came in at 20-2 for approval. The group's recommendation was not binding, but the FDA ultimately agreed upon their recommendation.
The results from the 2007-2008 National Health and Nutrition Examination Survey indicate that approximately 68% of adults in the United States are obese or overweight (Flegal 2010). Obesity is associated with numerous co-morbidities, including dyslipidemia, coronary artery disease, hypertension, stroke, cancer, and type 2 diabetes (Must 1999; Poirier 2006). Epidemiological data indicate obesity and excess weight as factors associated with an increased risk of premature death (Adams 2006; Katzmarzyk 2003). Recent data suggest that current increases in obesity rates could continue. At present, the only effective treatment for obesity is bariatric surgery; however, this approach has been reported to have significant complications.
Within five years, Qsymia could attain a significant share or the greatly enhances obesity market due to its efficacy and flexible dosing options that could suit a wide variety of patient profiles.
Qsymia is expected to replace current available agents and expand the weight management category to patients not currently receiving pharmacotherapy. The drug would be heavily marketed to primary care physicians, who currently account for about 90% of the current weight loss prescriptions. A global partner could also be sought.
1) Heart rate
2) Blood Pressure
3) Birth defects with WOCBP/teratogenicity
In conclusion, Qsymia new weight loss drug is one of the first new prescription diet pills in 13 years and follows the recent FDA approval for Arena Pharmaceuticals, Inc.'s (NASDAQ:ARNA) diet pill Belviq that received approval in June 2012.
Disclosure: I am long VVUS.