when will qnexa be available?

2 ANSWERS

1. amomipais82
   

   Hi,
   The new drug Qnexa for the treatment of obesity and weight loss shows promise. Qnexa is a proprietary therapeutic formulation and dosing regime that incorporates the active ingredients from two previously approved products with demonstrated weight loss properties. By combining the activity of each of these compounds, Qnexa simultaneously addresses appetite and satiety, the two main mechanisms that impact eating behavior. As such, Qnexa appears to induce significantly greater weight loss than either individual compound. Further, clinical trials conducted with Qnexa have demonstrated superior efficacy and a significantly improved adverse effect profile as compared to other therapeutic options.
   
   VIVUS and Duke University conducted a 200-patient, double-blind, placebo controlled Phase 2 trial designed to examine the safety and efficacy of Qnexa. Findings from this study demonstrated:
   
   * Qnexa achieved significantly greater weight loss as compared to placebo and each of the product's active ingredients alone
   * Qnexa achieved a placebo-adjusted weight loss of 20.1 pounds at week 24
   o This is nearly twice the weight loss achieved with a high dose of Sanofi-Aventis' Acomplia (rimonabant) at week 52 (10.6 pounds) in a similar group of patients
   * Weight loss with Qnexa had not plateaued at 24 weeks as has been observed with other obesity therapeutics in development
   * Only one patient dropped out of the Qnexa study arm due to side effects (2%) wih only 8% total non-completers for any reason. Dropouts for topiramate alone were 14%, phentermine alone 24%, and placebo 38%, indicating how well Qnexa was tolerated in this population.
   
   VIVUS is currently undertaking additional formulation development for Qnexa to increase the convenience of patient dosing. Ultimately, the final Qnexa formulation will offer once-a-day, oral dosing utilizing advanced sustained and controlled release technology which will provide precision release of each active ingredient in order to maximize efficacy and tolerability.

   Report (0) (2)  |   12 years, 8 month(s) ago  

2. Guest2756
   

   According to http://www.tesofensine-information.com/qnexa.html it will be sometime in mid to late 2010. Lorcaserin which was submitted just days before Christmas is said to take 10 months for the FDA to make their final decision. I am assuming that it will be probably similar for Qnexa. However it is possible that the FDA will not pass it.

   Report (1) (1)  |   12 years, 8 month(s) ago