Winston Pharmaceuticals, Inc. Receives Orphan Drug Designation for Novel Patch to Treat Post-Herpetic Neuralgia
25 2월 2009 - 12:54AM
Business Wire
Winston Pharmaceuticals, Inc. (OTC BB: WPHM) today announced
that it has received orphan drug designation from the U.S. Food and
Drug Administration (FDA) for its lead compound, Civamide, a novel
TRPV-1 receptor modulator, being developed as a dermal patch for
the treatment of post-herpetic neuralgia. Winston recently released
results of a Phase I study demonstrating the patch�s ease of use
with repeated 24-hour applications. The lack of systemic absorption
of Civamide from the patch should permit its use as either a
monotherapy or as adjunctive therapy in combination with systemic
medications used to treat post-herpetic neuralgia such as Cymbalta�
(Duloxetine) and Lyrica� (Pregabalin), without a risk of drug-drug
interactions. Winston is currently conducting a Phase II study of
the Civamide Patch in patients with chronic post-herpetic
neuralgia.
"FDA orphan drug designation provides multiple incentives for
the development of Winston�s Civamide Patch. Such designation will
permit the accelerated development and availability of the Civamide
Patch to patients suffering from this extremely painful condition,"
stated Joel E. Bernstein, MD, President and Chief Executive Officer
of Winston Pharmaceuticals, Inc. "The Civamide Patch represents a
quantum advance over current topical therapies for neuropathic
pain."
About Post-Herpetic Neuralgia
Post-herpetic neuralgia (PHN), is the pain persisting for at
least 3 months after a herpes zoster eruption (commonly referred to
as �shingles�) heals and is the most feared complication of the
disorder. The pain is often severe and can persist for as long as
10 or more years, leading to serious compromises in quality of
life, including depression and suicide. No treatments, oral or
topical, have proven universally beneficial or practical, given
their side effect profiles and the limitations of their
efficacy.
About Orphan Drug Designation
FDA orphan drug designation is designed to encourage
biotechnology and pharmaceutical companies to develop drugs for
rare diseases which affect fewer than 200,000 people in the United
States.�Administered by the Office of Orphan Drug Products,
potential incentives such as funding for clinical studies, study
design assistance, waiver of FDA user fees, tax credit, and
importantly, up to seven years of marketing exclusivity upon
approval of the NDA are provided.
About Winston Pharmaceuticals
Winston Pharmaceuticals is a development stage pharmaceutical
company focused on pain control. Winston is developing products for
large pain control markets, as well as for niche markets, where
there are still significant unmet needs for pain management options
with improved efficacy, safety, and tolerability profiles.
Winston's product candidates span a range of pain indications,
including arthritis, neuropathic pain, cancer pain, post-operative
pain, cluster headache and chronic daily headache.
This press release contains �forward-looking statements,� as
that term is defined under the Private Securities Litigation Reform
Act of 1995 (PSLRA), regarding product development efforts and
other non-historical facts about expectations, beliefs or
intentions regarding the business, technologies and products,
financial condition, strategies or prospects. Many factors could
cause actual activities or results to differ materially from the
activities and results anticipated in forward-looking statements.
These factors include those described in our filings with the
Securities and Exchange Commission, as well as risks inherent in
funding, developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments,
including the risks that any products under development may fail,
may not achieve the expected results or effectiveness and may not
generate data that would support the approval or marketing of
products for the ailments being studied or for other ailments. In
addition, forward-looking statements also may be adversely affected
by general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. We do not undertake any obligation to update
forward-looking statements. We intend that all forward-looking
statements be subject to the safe-harbor provisions of the
PSLRA.
Winston Pharmaceuticals (CE) (USOTC:WPHM)
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Winston Pharmaceuticals (CE) (USOTC:WPHM)
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