NexMed Denied FDA Approval for ED Drug

NexMed has received a not-approvable letter from the FDA for its topical treatment for erectile dysfunction (ED).

The major regulatory issue the FDA raised focused on a transgenic mouse carcinogenicity study that NexMed completed in 2002, according to the company. President and CEO Vivian Liu said the problem “is product specific and does not affect the dermatological products in our pipeline.”

The company is still interested in getting the drug approved and plans to meet with the FDA to determine what it has to do to resubmit the NDA, Hem Pandya, vice president and chief operating officer, said. It will submit final reports for two new two-year carcinogenicity studies in both mice and rats, which the agency has identified as part of the information it needs, he added.

The company sold worldwide rights to the topical onychomycosis treatment in its pipeline for $51 million and certain milestone payments to Novartis International, which assumed all development, manufacturing and marketing responsibilities, according to NexMed.

Onychomycosis is a fungal infection affecting toenails or fingernails and is one of the most common dermatological diseases, affecting an estimated 35 million Americans, according to the company.