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Carbidopa-Levodopa Orally Disintegrating Tablets Gain Approval
MILWAUKEE, Aug. 30 /PRNewswire/ -- SCHWARZ PHARMA, INC., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Parcopa™ (carbidopa-levodopa orally disintegrating tablets), a unique formulation of carbidopa-levodopa that dissolves rapidly on the tongue. Parcopa, which will be available in pharmacies September 27, 2004, is designed to provide patients suffering from Parkinson's disease improved access to their medication.
Parkinson's disease patients experience symptoms such as morning rigidity or "off periods" -- episodes of decreased movement or complete immobility during the day -- that can make dosing problematic. Unlike conventional carbidopa-levodopa tablets, Parcopa dissolves on the tongue using RapiTab™ technology to deliver medicine without the need for water, providing patients with a convenient means to take their medication.
"Parkinson's disease presents patients with a host of challenges that affect almost every aspect of their daily lives, including their ability to take medications that are necessary," said Ron Stratton, Ph.D., president and COO of SCHWARZ PHARMA, INC. "Parcopa was developed to offer a simpler and more convenient way for patients to access critical levodopa replacement therapy. For instance, because Parcopa does not require water, patients can easily take it upon waking to help get morning routines moving, resulting in an easier start to the day. They may also attain a greater sense of control over daily activities and reduce concern about dosing to treat 'off periods' by having Parcopa readily accessible at all times."
Parcopa is available in the same strengths and has the same dosage schedule as conventional Sinemet® (carbidopa-levodopa) Tablets. The most common side effects include involuntary movements and nausea. Each 10 mg/100 mg tablet and each 25 mg/100 mg tablet contain phenylalanine 3.4 mg. Each 25 mg/250 mg tablet contains phenylalanine 8.4 mg. For more information about Parcopa, talk to your healthcare provider or visit http://www.parcopa.com/.
About RapiTab™ Technology
SCHWARZ PHARMA's RapiTab™ Technology formulates medicines into orally disintegrating tablets that dissolve rapidly on the tongue. They can be swallowed with or without water and have pleasant tasting flavors such as citrus or mint. RapiTab tablets are convenient and easy for patients to administer, especially when water is not readily available or patients face certain obstacles to dosing. SCHWARZ PHARMA's RapiTab Technology is based on the proprietary DuraSolv technology developed by and licensed from CIMA LABS INC.®
RapiTab Technology has distinct advantages over freeze-dry technology. RapiTab Tablets are pleasant tasting, have good mouth feel and are easily soluble both in water and saliva. It can be used with a wide range of active ingredients and strengths. Unlike many other forms of fast-dissolve tablets, RapiTab tablets are durable and can be packaged in both blister packs and conventional bottles.
SCHWARZ PHARMA will use patented RapiTab Technology to develop a family of prescription pharmaceutical products for use in primary care, gastroenterology and neurology.
For more information on RapiTab Technology, please visit our web site at http://www.rapitabtech.com/.
The SCHWARZ PHARMA CNS Pipeline
SCHWARZ PHARMA is highly committed to the treatment of neurological disorders and has a robust pipeline including rotigotine CDS, a new dopamine agonist for transdermal treatment of Parkinson's disease. The Company recently reported successful completion of Phase III trials and plans to file for regulatory approval in Q3 2004. The Company is also investigating the use of rotigotine CDS for treatment of Restless Legs Syndrome (RLS), an unpleasant hyperkinesia of the legs that occurs primarily at night.
Harkoseride, a novel agent being investigated for both the treatment of epilepsy and neuropathic pain, is currently in Phase III trials.
Source: Schwarz Pharma, Inc.