NexMed To Discuss P2/3 Protocol For NexACT®-Based Alprostadil Treatment For Raynaud’s Syndrome With The FDA
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO with a pipeline of products based on the NexACT ® technology, 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 E 1 (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.”
About NexMedNexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and i n vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT ® drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT ®-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com. Forward-Looking Statement Safe Harbor for NexMed Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including but not limited to, its ability to have the resources necessary to complete clinical testing and obtain regulatory approval for its products under development.
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