MILWAUKEE, Feb. 14 /PRNewswire-FirstCall/ -- A clinical study published in the January 2005 issue of “Clinical Therapeutics” showed that more than twice as many Parkinson’s disease patients prefer Parcopa(TM) (carbidopa-levodopa orally disintegrating tablets) to conventional carbidopa-levodopa tablets. The primary factors influencing their preference were greater access to medication to treat “off” times, ease of performing daily activities, use for nighttime dosing and feeling less self-conscious about others noticing medication use. Parcopa is a unique formulation of carbidopa-levodopa that dissolves on the tongue without the need for water.
“Since Parkinson’s disease patients experience symptoms such as tremors, rigidity and episodes of decreased movement or complete immobility, especially in the morning, compliance and access to medication can be a problem,” said Michele Tagliati, MD, Director of the Parkinson’s Disease Center at the Mount Sinai Medical Center in New York. “This study showed that Parcopa offers important benefits for many patients. Those who expressed a preference, preferred an orally dissolving tablet because they felt it was more convenient and easier to access -- which is particularly important for patients suffering from parkinsonian symptoms.”
Study Design and Results
The multicenter, open-label, sequential study compared preferences for carbidopa-levodopa orally disintegrating tablets versus conventional tablets in 60 Parkinson’s disease patients who had taken a stable dose of conventional carbidopa-levodopa for at least 30 days prior to the trial. Patients received conventional tablets for 7 +/- 3 days, followed by Parcopa for 14 +/- 3 days. During the last 3 days of each treatment period, they recorded their “on” and “off” times and medication use in a diary. On the last day of each treatment period, the Unified Parkinson’s Disease Rating Scale (UPDRS) was administered. At the end of the study, patients completed a Global Preference Questionnaire (GPQ).
Nearly half (45%) of the study subjects preferred orally dissolving tablets, 35% had no preference and 20% preferred the conventional tablets. Factors cited as contributing to their preference for the orally dissolving formulation included:
Reasons Cited for Preference Percentage of Patients Greater access to medication to treat “off” times 50% Easier to perform daily activities 47% Reduced concern about swallowing medication 45% Use for nighttime dosing 42% Less self-conscious about use in public 42% About Parcopa
Recently approved by the FDA, Parcopa (carbidopa-levodopa orally disintegrating tablets) is a combination of carbidopa and levodopa in tablets that dissolve rapidly on the tongue, without the need for water. Parcopa’s orally dissolving formulation is designed to provide Parkinson’s disease patients with improved access to their medication. Parcopa is used to treat symptoms of Parkinson’s disease, including tremors, stiffness and slowness of movement, and may permit the patient better mobility.
Parcopa is available in the same strengths and has the same dosage schedule as conventional Sinemet(R) (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(TM) Technology
SCHWARZ PHARMA’s RapiTab(TM) 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(R) technology developed by and licensed from CIMA LABS INC.(R) 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 filed for regulatory approval in 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.
Lacosamide, a novel agent being investigated for both the treatment of epilepsy and neuropathic pain, is currently in Phase III trials.
About SCHWARZ PHARMA
SCHWARZ PHARMA, INC., based in Milwaukee, WI, is a pharmaceutical company with proven expertise in the areas of cardiology, gastroenterology, urology and neurology. SCHWARZ PHARMA, INC., is an affiliate of SCHWARZ PHARMA AG (headquartered in Monheim, Germany). The SCHWARZ PHARMA Group develops and markets innovative drugs for unmet medical needs with a focus on the therapeutic areas of neurology, urology as well as cardiovascular and gastrointestinal diseases. The Company is investing in research and development projects targeting diseases such as Parkinson’s disease, Restless Legs Syndrome, epilepsy, neuropathic pain, overactive bladder syndrome/ incontinence and benign prostatic hyperplasia. SCHWARZ PHARMA has a strong multinational presence that includes affiliates in Europe, the U.S. and Asia. Shares of SCHWARZ PHARMA AG are traded on the Frankfurt and Dusseldorf stock exchanges.
Contact at SCHWARZ PHARMA AG / Investor Relations: Antje Witte; Phone: +49 2173 48 1866; email: antje.witte@schwarzpharma.com.
For more information about Schwarz Pharma, visit http://www.schwarzusa.com/ or http://www.schwarzpharma.com/.
Sinemet(R) is a registered trademark of Merck & Co., Inc. DuraSolv(R) is a registered trademark of CIMA LABS, INC.(R) References:
Nausieda PA, et al. A Multicenter, Open-Label, Sequential Study Comparing Preferences for Carbidopa-Levodopa Orally Disintegrating Tablets and Conventional Tablets in Subjects with Parkinson’s Disease. Clin Ther 2005; 27(1): 58-63.
This press release contains forward-looking statements based on current plans, estimates and beliefs of the management of SCHWARZ PHARMA AG. These forward-looking statements are subject to various risks and uncertainties that may cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks and uncertainties that could cause a material difference in future results include changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing. The Company does not undertake any responsibility to update the forward-looking statements contained in this press release.
SCHWARZ PHARMA Inc.
CONTACT: Amanda Taylor, Kovak-Likly Communications, +1-203-762-8833 orataylor@klcpr.com, for SCHWARZ PHARMA
