First Horizon Pharmaceutical (NASDAQ:FHRX)
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First Horizon Pharmaceutical Corporation (NASDAQ:FHRX)
today announced that the U.S. Food and Drug Administration (FDA) has
granted orphan drug designation for the Company's glycopyrrolate,
which is used to treat chronic moderate to severe drooling in
pediatric patients. This condition often results from cerebral palsy
and other neurological disorders. The Company currently is conducting
clinical trials for this indication. Glycopyrrolate, an
anticholinergic agent, also is approved as an adjunctive therapy in
the treatment of peptic ulcers.
Larry M. Dillaha, M.D., Executive Vice President and Chief Medical
Officer of First Horizon, said, "We plan to work diligently to
complete our clinical trials for this much needed therapeutic
treatment option for children who suffer from chronic moderate to
severe drooling caused by cerebral palsy and certain other
neurological disorders."
The FDA orphan drug designation is intended to provide incentives
to encourage the development of drugs for diseases affecting fewer
than 200,000 people in the U.S. Following FDA approval, the Orphan
Drug Act provides drug market exclusivity for a period of seven years
for a product's orphan indication. Additional incentives include tax
credits related to clinical trial expenses, exemption from the FDA
user fee, and FDA assistance in clinical trial design.
Patrick Fourteau, President and CEO of First Horizon, stated, "The
development of this new formulation of glycopyrrolate by First
Horizon, together with this orphan drug designation - the first for
the Company - are the result of our recently expanded Medical Affairs
and Regulatory Group and our increased investment in new product
development."
About First Horizon Pharmaceutical Corporation
First Horizon Pharmaceutical Corp. is a pharmaceutical company
specializing in sales, marketing and the development of branded
prescription products focused on Cardiovascular/Metabolic and Women's
Health. The Company's Cardiovascular/Metabolic products treat patients
with high cholesterol, hypertension, high triglycerides, unstable
angina and type 2 diabetes, and its Women's Health products are
designed to improve the health and well-being of women and their
babies. Headquartered in Atlanta, Georgia, and founded in 1992, First
Horizon employs more than 700 people, including approximately 525
sales representatives. The Company's success is based on placing the
needs of patients first, improving health and quality of life, and
implementing its business platform - an Entrepreneurial Spirit,
Innovation, Speed of Execution, Simplicity and Teamwork. For more
information about the Company and its products, visit www.fhrx.com.