FDA Approves Tri-Nasal , Muro Pharmaceutical, Inc.'s New Allergy Relief Medication.Business & Health Editors TEWKSBURY, Mass.--(BW HealthWire)--May 2, 2000 Tri-Nasal (triamcinolone acetonide, USP USP - unique sales point ) Nasal Spray 50 mcg Provides a New Treatment Option for Patients Ages 12 and Over with Seasonal and Perennial Allergic Rhinitis Muro Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved its intranasal steroid medication, Tri-Nasal (triamcinolone acetonide, USP) Nasal Spray, 50 mcg for the treatment of seasonal and perennial allergic rhinitis in adults and children twelve years of age and older. Tri-Nasal provides once-a- day dosing and a recommended starting dose regimen of two sprays per nostril nostril /nos·tril/ (nos´tril) either of the nares. nos·tril n. A naris. nostril either of the two apertures (nares) of the nose that lead into the nasal cavity. (200 mcg total daily dose). "Tri-Nasal offers allergic rhinitis patients a new safe, effective and economical option to their current treatment therapy," commented Colin Stewart, President and Chief Executive Officer of Muro Pharmaceutical, Inc. The marketing of Tri-Nasal will begin with a launch by Muro's over 200 member sales force targeted to the allergy specialist, primary care physicians and retail pharmacies. Tri-Nasal(R), the only once-daily nasal steroid solution approved in the U.S., was proven safe and efficacious during extensive clinical investigations in 1187 patients. The clinical development program included evaluations of efficacy, safety, pharmacodynamics pharmacodynamics /phar·ma·co·dy·nam·ics/ (-di-nam´iks) the study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical , and pharmacokinetics. Tri-Nasal (R) was significantly more effective than vehicle placebo in relieving nasal congestion, sneezing, rhinorrhea, and itching symptoms associated with allergic rhinitis. The most commonly reported adverse events were headache, pharyngitis pharyngitis Inflammation and infection (usually bacterial or viral) of the pharynx. Symptoms include pain (sore throat, worse on swallowing), redness, swollen lymph nodes, and fever. , back pain and taste perversion. Muro Pharmaceutical, Inc., located in Tewksbury, MA, is a United States subsidiary of ASTA Medica medica (māˑ·dē·k AG, a research based, international pharmaceutical company headquartered in Germany. ASTA Medica AG is a 900 million dollar a year company with leading products in the fields of anticancer drugs, central nervous system agents, and respiratory therapies. The ASTA Medica group is represented with its own subsidiaries and agents in 47 countries on every continent. The replacement of a systemic corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. See attached product insert for additional information. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion