First Horizon Receives FDA Orphan Drug Designation for Its Glycopyrrolate to Treat Chronic Drooling in Pediatric Patients
Posted on: Wednesday, 14 June 2006, 09:00 CDT
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.
Source: Business Wire
Related Articles
- Progenics Selects Hepatitis Drug Candidate for Clinical Development
- Progenics Selects Small-Molecule Hepatitis C Drug Candidate for Clinical Development
- Algeta Receives IND Approval for Alpharadin(TM) to Commence Clinical Development in the USA
- RegeneRx Names Drug Products Under Clinical Development
- Sequella Lead Drug Compound SQ109 Receives Orphan Drug Status From the US FDA and Orphan Medicinal Product Designation From the European Medicines Agency for the Treatment of Tuberculosis
- Expression Genetics, Inc. Receives Orphan Drug Grant From FDA for Clinical Development of EGEN-001 for Treatment of Ovarian Cancer
- Innocoll Receives FDA Approval to Commence Phase 2 Clinical Development With Its CollaRx(R) BUPIVACAINE IMPLANT for the Management of Post-Operative Pain
- DNAPrint Pharmaceutical Completes Sterility Testing on Anemia Drug Cell Lines for Clinical Development
- Webcast Alert: Isis Pharmaceuticals' Clinical Development Guidance Conference Call
 |
 |
User Comments (0)
RSS Feeds