NexMed to Discuss P2/3 Protocol for NexACT®-Based Alprostadil Treatment for Raynaud’s Syndrome with the FDA
May 17 2010 - 5:11PM
Business Wire
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 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.”
About NexMed
NexMed is the largest specialty CRO based in San Diego, CA and
is one of the industry's most experienced CROs for in vitro and in
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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