DALLAS, Jan. 24, 2011 (GLOBE NEWSWIRE) -- MicroStockProfit.com announces an investment report featuring VIVUS Inc. (Nasdaq:VVUS). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.
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VIVUS Inc. (VVUS) is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes, obstructive sleep apnea and sexual health. Its lead product in clinical development, Qnexa, completed phase 3 clinical trials for the treatment of obesity and a New Drug Application (NDA) was filed and accepted by the Food and Drug Association (FDA). The Company received a Complete Response Letter (CRL) from the FDA and is preparing a written response to address the FDA's requests for information included in the CRL. Qnexa is also in phase 2 clinical trials for type 2 diabetes and obstructive sleep apnea. VVUS is also developing an erectile dysfunction drug, Avanafil, that is in phase 3 clinical trials.
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In the report, the analyst notes:
"VVUS last week said U.S. health regulators asked the Company to explore the feasibility of running an analysis of data from existing health-care databases to see if there is a link between women taking the drug topiramate and the incidence of cleft lip or palate in their children. VVUS shares dropped on the news, dropping 16.20%.
" VVUS has previously expressed confidence in its data analyses to address safety concerns. It said the timing of the planned resubmission of Qnexa will be determined after agreement with the FDA is reached on the feasibility assessment."
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