Experimental drug firm Vivus have announced that they have now applied to the FDA for approval of their slimming drug Qnexa.They said that the phase 3 program for the drug has now been completed, showing that patients treated with three different doses of the medication all showed significant reducation in their total body fat when compared to the placebo. Vivus' chief executive Leland F Wilson said, ""The weight loss of up to 14.7% (37 pounds) combined with significant improvements in weight-related medical conditions, such as hypertension, diabetes, and dyslipidemia, demonstrates the importance of treating obesity, which has become a major epidemic in the United States and many developed countries."The pill is designed to be taken once a day and contains low doses of phentermine, previously discontinued as a weight-loss drug, and topiramate. Together the drugs are believed to reduce appetite and make patients feel fuller, both of which should improve patient's eating habits. The drug has generated a lot of interest in the press, as it is one of a number of new-generation slimming pills seeking approval from the FDA. The others include Orexigen Pharmaceutical's Contrave and Empatic, and Tesofensine.There is now keen interest as to which drug will be approved and hits the shelves first. The slimming pill market is worth billions of dollars and for the pharmaceutical companies, getting their drug on the market as early as possible would allow them time to generate brand recognition, crucial to high sales, before they were faced with further competition. Tesofensine is still in the clinical trial stage, though results from the stage II trials were extremely promised. Orexigen are closer to the holy grail, FDA approval, with completed and successful phase 3 trials for Contrave and Empatic and a rising share price, reflecting market enthusiasm for the product.Leland Wilson said that filing the New Drug application for Qnexa with the FDA was significant event for the pharmaceutical company. He commented, "This NDA filing is a major milestone for VIVUS and the Qnexa program. I wish to thank all of the VIVUS employees, contractors and advisors who contributed to the program and made this on-time filing possible."
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