The FDA has handed NexMed a non-approvable letter for its experimental topical therapy for ED. NexMed says that the results of the transgenic mouse carcinogenicity study back in 2002 was related to the rejection, but noted that the study was product specific and not relevant to its other development programs.
"While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected," said CEO Vivian Liu. "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."
NexMed says that it will evaluate the FDA letter and then address the issues in a response.
- check out NexMed's release