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Qsymia/Qnexa Archived News 2006 - 2009
Dec 29th, 2009
Vivus Inc today submitted Qnexa to the FDA for the treatment of obesity. It is expected that sometime in mid 2010 that the FDA will hold an advisory committee and discuss its trials and provide a recommendation vote for the FDA to later decide on its outcome.
Sept 9th, 2009
Results on a phase 3 test commencing over a 56 week period of time showed that Qnexa had an average weight reduction in its patients of 14.7%. Cardiovascular factors also showed an improvement. Overall the tolerability was considered decent and the benefits vs risks showed to be favorable. Some of the side effects reported where a tingling sensation on the skin, altered taste, dry mouth and constipation.
Jan 13th, 2009
The European Patent Office has officially issued Vivus Inc a patent for Qnexa.
Dec 11th, 2008
The first phase 3 testing results where made public. Encouraging weight loss effects where shown. The trial lasted 28 weeks and consisted of 756 overweight people. Three different dosages where used. The group who was taking the highest dose of Qnexa lost on average 9.2% of their weight, the mid-dose group lost an average of 8.5% The placebo group lost a mere 1.7%.
June 10th, 2008
Vivus Inc release news today part way through the phase 3 trial that Qnexa was shown to reduce blood sugar levels in type 2 diabetic patients in addition to weight loss. This part of the testing consisted of 206 patients with type 2 diabetes. Testing showed that Qnexa was responsible for a 1.2% decrease in hemoglobin A1c. The placebo group had a 0.6% reduction.
November 9th, 2007
Phase 3 testing of Qnexa commenced today. There are approximately 1250 clinically obese patients who have a body mass index (BMI) of at least 35. People who have a BMI of 30 are considered obese. At least 20% of these patience are men. Upwards of 120 different testing centers will be used. The testing will take place for a 56 week period and will be a placebo controlled, double blind and randomized.
The following doses of Qnexa are being used in a once a day formula.
Full strength: 15mg Phentermine IR + 92mg of Topiramate CR
Mid strength: 7.5mg Phentermine IR + 46mg of Topiramate CR
Low strength: 3.75mg Phentermine IR + 23mg of Topiramate CR
June 13th, 2006
The U.S. Patent and Trademark Office has issued Vivus Inc the patent for Qnexa as an investigational oral treatment for obesity. This patent expires in 2019.
May 10th 2006
Positive results where announced today from Vivus, Inc regarding their clinical trial with Qnexa.
There were 159 women and 41 men who where categorized as clinically obese who took place in the study lasting 24 weeks. The testing took place at Duke University's Medical Center in North Carolina. In these tests more than half of the patients lost at least 10% body weight. This percentage equaled to an approximate 25 pound loss. The placebo group lost approximately 5 pounds on average. Interestingly, there was no plateau in the weight loss progress towards the end of the study. Of the 200 that had enrolled, 4 patients taking the drug dropped out where as there where actually 19 that dropped out who where on the placebo.