Vivus Inc. (VVUS) recently announced positive data from a two-year trial of its weight loss, once-daily pill Qnexa. The data, reported from the extended 52-week SEQUEL study, covered 675 overweight or obese patients. The SEQUEL trial followed the 56-week CONQUER trial.
The patients who took the highest dose of Qnexa during the total 108 weeks of the study experienced and maintained an average weight loss of 11.4% or 26 pounds. The candidate was well tolerated in the SEQUEL study, with the most common adverse events being constipation, tingling, dry mouth, altered taste and insomnia.
Back in July, the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) had voted against the approval of Qnexa, stating that the risks of taking the drug outweighed its benefits.
The FDA panel’s recommendation was based on the results of the 56-week CONQUER trial, in which Qnexa though found efficacious for weight loss, triggered several side effects like memory loss, depression/suicidal thoughts, birth defects, higher heart rates and other cognitive problems associated with the use of the drug.
The SEQUEL study, however, did not report any suicidal attempts. The frequency of sleep disorders, depression, anxiety, cardiac disorders and cognitive disorders were also lower in this follow-on trial as compared with the preceding CONQUER study.
Qnexa is a combination of two drugs: amphetamine phentermine, which suppresses appetite, and topiramate, an anti-seizure drug sold by Johnson & Johnson (JNJ) as Topamax.
The obesity market holds immense commercial potential and the approval of Qnexa would be a major boost for Vivus. The Centers for Disease Control and Prevention estimates that over 112,000 deaths each year are attributable to obesity. Moreover, Americans spend more than $30 billion annually on weight-loss products and services.
We currently have a Neutral recommendation on Vivus, which is supported by a Zacks #3 Rank (short-term Hold rating). Though we view the SEQUEL data as positive for Vivus, we expect investor focus to remain on the FDA’s decision of Qnexa’s approvability, which is expected by October 28.
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