NexMed, Inc., a developer of innovative treatments based on its proprietary topical drug delivery technology, has begun the Phase 3 open-label study of Alprox-TD, its proprietary cream treatment for male erectile dysfunction ("ED"). NexMed is conducting the open-label study of Alprox-TD at 80 clinical research centers across the U.S.
Dr. James L. Yeager, senior vice president for scientific affairs commented, "The new Phase 3 open-label study is intended to confirm the safety of Alprox-TD on a longer term basis. This study will include new patients as well as those who have completed testing in one of the two pivotal Phase 3 studies and elect to continue using Alprox-TD for an additional period." Dr. Yeager added, "Completion of the open-label study is not a prerequisite for our New Drug Application (NDA) submission."
NexMed's Phase 3 clinical development program will enroll a total of 2,500 patients with mild, moderate or severe ED. In addition to the open-label study, NexMed is also conducting two multi-center, double-blind, placebo-controlled, randomized Phase 3 studies which were initiated in November 2001. NexMed anticipates that at the current rate of patient enrollment and completion, these two pivotal Phase 3 studies should be completed by year-end 2002, and the NDA submitted to the FDA during first half of 2003.
Alprox-TD incorporates alprostadil, a drug well recognized for treating ED, with the NexACT transdermal delivery technology. The product is pre-filled and packaged in NexMed's patented Accudose dispenser, which is designed to provide an added convenience for patients. The disposable Accudose dispenser delivers a controlled dose of cream directly onto the tip (meatus) of the penis thereby reducing dosing errors and waste.