BioSante plans an NDA submission for its transdermal estradiol gel Bio-E-Gel "as soon as possible" following positive results from a Phase III trial in menopausal women. The 12-week, 484-patient study looked at three dose levels. Beginning at week five, highly significant decreases in the number (p<0.001) and severity (p<0.01) of hot flashes compared to placebo were observed with the lowest study dose. "We believe the low dose…will be an attractive alternative to currently marketed estrogen therapies," BioSante says. The company is aiming at the market created largely by Solvay's EstroGel. BioSante also hopes to tap into the female sexual dysfunction market with its testosterone gel LibiGel. A Phase III study in FSD is slated to begin by year-end (1Pharmaceutical Approvals Monthly April 2005, p. 5)...

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...

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011