Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity Society 27th Annual Scientif...(than the similar event rates reported in...),Health

The label for Topamax for the prevention of migraine includes a discontinuation rate due to disturbance in attention of 3%. In addition, discontinuation rates for attention in a published study on topiramate monotherapy were 3% to 4% for doses from 96 to 192 mg (Wilding, et. al., International Journal of Obesity).

The clinical relevance of the effect of Qnexa on cognitive function is low, as demonstrated by the results from a prospective evaluation of cognitive function using RBANS (Repeatable Battery for the Assessment of Neuropsychological Status), a validated tool administered during previous clinical studies of Qnexa (OB-301 and DM-202/DM-230). Dr. Christopher Randolph, clinical professor at Loyola University Medical School in Maywood, Ill., the developer of the RBANS instrument and an expert in the assessment of cognitive function, reviewed the results of the RBANS studies. Dr. Randolph commented, "My overall impression from the RBANS data is that Qnexa at the doses tested does not appear to produce a clinically significant change in cognitive function in this patient population."

"Qnexa is a proprietary formulation of controlled release topiramate and phentermine. As evidenced by the high retention and low dropout rates in the pivotal trials, we believe the reduced Cmax of topiramate, in the presence of phentermine, has a beneficial net effect on centrally mediated adverse events such as attention, as compared to commercially available topiramate formulations," stated Wesley Day, vice president of clinical development of VIVUS.

"The integrated safety summary for the year-long studies showed that discontinuation rates due to cognitive side effects were minimal as no MedDRA preferred term associated with cognitive effects resulted in discontinuation in more than 1% of subjects. Previous studies of topiramate monotherapy have
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