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NexMed Alprox NDA prep

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

NexMed anticipates submitting an NDA for Alprox-TD (topical alprostadil) first-half 2005 for erectile dysfunction, "assuming we begin patient enrollment for the long-term open-label study in March 2004," company says March 4. Completion of the 12-month study is not a prerequisite for submission provided FDA receives a 12-month safety update on 100 patients within four months of NDA submission. NexMed discussed several other planned studies at a presubmission review meeting with FDA, including a study in men who have failed oral ED medication. Although such a study is typically done as Phase IV, "based on the positive response from the FDA to this proposal, we are considering initiation of this study now, so that the study results can be incorporated into the NDA." A tolerance study in female patients will be done concurrently; the firm is "about to submit a study plan to the FDA." NexMed will also conduct two bridging studies to support use of a new Alprox-TD formulation that increases shelf-life...

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