FDA News

NexMed Receives FDA Response for ED Product

(July 22, 2008)-- NexMed announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.

Commenting on today's announcement, Vivian Liu, President and Chief Executive Officer of NexMed said, "The transgenic mouse concern raised by the FDA is product specific, and does not affect the dermatological products in our pipeline. While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency. We are encouraged that we do not need to redo this study, which would have taken up to 18 months to complete and at a substantial cost."

Hem Pandya, Vice President and Chief Operating Officer of NexMed added, "We remain committed to bringing our ED product to market, where there is a real demand from both patients and the urology community at large. As such, we plan to meet with the FDA and come to agreement on the necessary actions required in order to resubmit our NDA and resolve the deficiencies cited." Mr. Pandya further added, "We will also submit to the Agency final reports for two new, two-year carcinogenicity studies in both mice and rats, which were identified in the FDA's letter as part of the information package needed to resolve the major deficiencies cited."

For further information about NexMed, go to www.nexmed.com.

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