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Qnexa improves quality of life in the obese

Additional data from the phase III trial of Vivus’s obesity therapy candidate Qnexa has demonstrated significantly increased quality of life compared with placebo
Vivus has presented additional data that demonstrates that its anti-obesity treatment candidate Qnexa (phentermine and topiramate) significantly improves quality of life in obese patients, during the American Association of Diabetes Educators (AADE) meeting in Las Vegas, Nevada. 

The quality of life improvements, assessed during the 56-week phase III EQUIP and CONQUER studies, were measured using two validated surveys: the Impact of Weight on Quality of Life-Lite (IWQOL-Lite), which assessed patients in both EQUIP and CONQUER, and the Medical Outcomes Short Study Form-36 (SF-36), which was used to assess patients specifically in the CONQUER trial. The analysis also demonstrated that, regardless of treatment group, greater weight loss was associated with greater improvements in quality of life.

The positive results of the phase III trials are in contrast to other recent announcements from Vivus regarding the drug, despite positive phase II and III clinical data, in which patients have demonstrated statistically significant weight loss, glycaemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification programme.

However, in a closed vote at a US Food and Drug Administration (FDA) advisory committee meeting in July 2010, panel members recommended against approval of Qnexa as an obesity treatment, citing the increased risk of psychiatric and cognitive issues linked to the drug in the company's trials.

In January 2011 the FDA asked Vivus for more safety information on Qnexa: at an end-of-review meeting with the company, the FDA asked Vivus to consider whether it was feasible to analyse existing data to determine the historical incidence of oral cleft in the children of women who have taken topiramate as a prophylaxis for migraine. However, the FDA did not request that the company conduct additional clinical trials. Vivus emphasised that in its own clinical trials of Qnexa, which included 15 births from women who took the drug, there were no reports of birth defects.

Qnexa is also under investigation for the treatment of associated conditions type 2 diabetes and obstructive sleep apnoea. 

9th August 2011

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