Message #30 From:
NewsBot Date: December 5, 2006 04:30:00 AM
ISPH News Inspire Initiates Phase 2 14-Day Clinical Trial of Epinastine for Seasonal Allergic Rhinitis
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the
initiation of a Phase 2 clinical trial to evaluate epinastine nasal
spray for the treatment of seasonal allergic rhinitis.
This Phase 2 clinical trial is a 14-day randomized, double-blind
comparison of two doses of epinastine nasal spray (0.05% and 0.1%) to
placebo in approximately 580 subjects who have a documented history of
seasonal allergic rhinitis to mountain cedar pollen. The trial will be
conducted at seven clinical sites during the mountain cedar pollen
season, which typically begins in early December, primarily in central
Texas. There are multiple objectives of this dose-ranging trial,
including the measurement of nasal and non-nasal symptoms, quality of
life scores and standard safety assessments. The doses being studied in
this trial were selected based on a small Phase 2 trial completed in
October 2006, combined with the pre-clinical pharmacology data compiled
to date.
“Given my positive experience with the ocular
form of epinastine (Elestat®),
I am pleased to have the opportunity to evaluate the nasal form of
epinastine,” stated Paul H. Ratner, M.D.,
medical director of Sylvana Research Associates. Dr. Ratner is a
specialist in allergy, asthma and immunology, and a principal
investigator in the upcoming mountain cedar allergic rhinitis trial. “An
antihistamine that is delivered directly to the nose as a nasal spray
has the potential to be effective in providing rapid relief for allergy
patients with minimal side effects.”
“With the initiation of this trial, we are
making excellent progress in our epinastine nasal spray development
program,” stated Christy L. Shaffer, Ph.D.,
President and CEO of Inspire. “We expect to
report the trial results by mid-year 2007.”
Inspire previously acquired certain exclusive rights from Boehringer
Ingelheim to develop and market an intranasal dosage form of epinastine
in the United States and Canada for the treatment or prevention of
rhinitis.
About Inspire
Inspire is a biopharmaceutical company dedicated to discovering,
developing and commercializing prescription pharmaceutical products in
disease areas with significant commercial potential and unmet medical
needs. The research and development programs of Inspire are driven by
extensive scientific experience in the therapeutic areas of
ophthalmology and respiratory/allergy, and supported by expertise in the
field of P2 receptors. Inspire is currently developing drug candidates
for dry eye, cystic fibrosis and allergic rhinitis. Inspire’s
U.S. specialty sales force promotes Elestat®
(epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitis
and Restasis®
(cyclosporine ophthalmic emulsion) 0.05% for dry eye, ophthalmology
products developed by Allergan, Inc. Elestat and Restasis
are trademarks owned by Allergan. For more information, visit www.inspirepharm.com.
Forward-Looking Statements
The forward-looking statements in this news release relating to
management's expectations and beliefs are based on preliminary
information and management assumptions. Such forward-looking statements
are subject to a wide range of risks and uncertainties that could cause
results to differ in material respects, including those relating to
product development, revenue, expense and earnings expectations, the
seasonality of Elestat, intellectual property rights, adverse
litigation developments, adverse developments in the U.S. Securities and
Exchange Commission (SEC) investigation, competitive products, results
and timing of clinical trials, success of marketing efforts, the need
for additional research and testing, delays in manufacturing, funding,
and the timing and content of decisions made by regulatory authorities,
including the U.S. Food and Drug Administration. Inspire cannot
guarantee the outcome or timing of the clinical or toxicology studies
for epinastine for allergic rhinitis. The timing of this Phase 2
clinical trial may be dependant upon the FDA’s
review of additional information provided in November 2006, including
the clinical trial protocol. A significant amount of work will be
required to advance epinastine nasal spray through clinical testing,
including satisfactory completion of additional clinical trials
(including Phase 3 clinical trials) and additional toxicology studies.
Even if the future development program for epinastine nasal spray is
successful, Inspire cannot predict when, or if, the FDA or other
regulatory authorities will approve epinastine nasal spray for allergic
rhinitis. Further information regarding factors that could affect
Inspire's results is included in Inspire's filings with the SEC. Inspire
undertakes no obligation to publicly release the results of any
revisions to these forward-looking statements that may be made to
reflect events or circumstances after the date hereof.
