NexMed (NEXM) Gets IND for NexACT-Based Alprostadil
NexMed, Inc. (Nasdaq: NEXM) today announced that the U.S. Food & Drug Administration (FDA) has granted the Company an Investigational New Drug application number for its NexACT-based alprostadil treatment for Raynaud’s syndrome, ahead of a pre-IND meeting in mid-July 2010 to discuss its proposed Phase 2/3 protocol. The Company is in late stage development for Vitaros, its topically applied NexACT-based alprostadil treatment for erectile dysfunction.
Raynaud's syndrome refers to a disorder in which the fingers or toes (digits) suddenly experience decreased blood circulation, and is characterized by color changes of the skin of the digits upon exposure to cold or emotional stress. The prevalence of Reynaud's syndrome in the general U.S. population is estimated to vary from 4–15%. Females are seven times more likely to develop the condition than men. For most patients, Raynaud’s syndrome is an inconvenience. However, chronic recurrent cases of Raynaud’s syndrome can result in atrophy of the skin, subcutaneous tissues and muscle. In rare cases it can cause ulceration and ischemic gangrene.
Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, stated, “Given the disease characteristics, Raynaud’s syndrome is an appealing product opportunity for us and one that we believe can benefit strongly from the active ingredient in Vitaros, which is alprostadil, or prostaglandin E1 (PGE1), a potent vasodilator. With the safety and efficacy of the currently approved, injectable PGE1 already well demonstrated, together with NexMed’s existing safety and efficacy clinical database for Vitaros, our intention is to move our topical Raynaud’s product candidate directly into Phase 2/3 clinical testing as soon as possible. We look forward to our meeting with the FDA in mid-July to further discuss our clinical development plan for this potential new therapy.”
Raynaud's syndrome refers to a disorder in which the fingers or toes (digits) suddenly experience decreased blood circulation, and is characterized by color changes of the skin of the digits upon exposure to cold or emotional stress. The prevalence of Reynaud's syndrome in the general U.S. population is estimated to vary from 4–15%. Females are seven times more likely to develop the condition than men. For most patients, Raynaud’s syndrome is an inconvenience. However, chronic recurrent cases of Raynaud’s syndrome can result in atrophy of the skin, subcutaneous tissues and muscle. In rare cases it can cause ulceration and ischemic gangrene.
Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, stated, “Given the disease characteristics, Raynaud’s syndrome is an appealing product opportunity for us and one that we believe can benefit strongly from the active ingredient in Vitaros, which is alprostadil, or prostaglandin E1 (PGE1), a potent vasodilator. With the safety and efficacy of the currently approved, injectable PGE1 already well demonstrated, together with NexMed’s existing safety and efficacy clinical database for Vitaros, our intention is to move our topical Raynaud’s product candidate directly into Phase 2/3 clinical testing as soon as possible. We look forward to our meeting with the FDA in mid-July to further discuss our clinical development plan for this potential new therapy.”
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