- Acorda Received FDA Approval in January 2010 for AMPYRA™, A New Treatment for People with Multiple Sclerosis
HAWTHORNE, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the National Organization for Rare Disorders (NORD) is recognizing the Company for its efforts to develop therapies for rare diseases. Earlier this year, Acorda received approval from the U.S. Food and Drug Administration (FDA) for AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, the first therapy to improve walking in people with multiple sclerosis (MS). This was demonstrated by an improvement in walking speed. The award will be presented tonight at the 2010 NORD Partners in Progress Gala in Washington, D.C.
“NORD plays a critical role in advocating for public policies that encourage public and private investment in development of therapies for rare diseases. This effort helps to ensure that patients with rare diseases have hope for future treatments,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. ”NORD is also an invaluable resource for people affected by rare diseases, providing information, education and support services to patients, families, medical professionals, and the public. We are honored to be recognized by an organization that has made such important contributions to medicine and society.”
“Multiple sclerosis is a progressive disease with devastating health consequences, and new treatment options are needed to improve the lives of people with MS,” said Peter L. Saltonstall, President and CEO of NORD. “We commend Acorda for its commitment to bringing novel therapies to market for people with MS and other neurological diseases.”
In the United States, a disease is considered rare if it affects fewer than 200,000 Americans. According to the National Institutes of Health (NIH), there are nearly 7,000 such diseases. Although MS is now estimated to affect between 400,000-500,000 Americans, it was classified as a rare disease at the time that Acorda began developing AMPRYA.
About AMPYRA™ (dalfampridine) Extended Release Tablets, 10 mg
AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA, which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine. In laboratory studies, dalfampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA is being developed and commercialized in the United States by Acorda Therapeutics, and by Biogen Idec in markets outside the U.S. based on a licensing agreement with Acorda. AMPYRA is manufactured globally by Elan based on a supply agreement with Acorda.
AMPYRA is now available by prescription in the United States. For more information about AMPYRA, including patient assistance and co-pay programs, healthcare professionals and people with MS can contact AMPYRA Patient Support Services at 888-881-1918.
AMPYRA Patient Support Services is available Monday through Friday, from 8:00 a.m. to 8:00 p.m. Eastern Time at 888-881-1918. For full U.S. Prescribing Information and Medication Guide, please visit: www.AMPYRA.com.
Important Safety Information
AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses. AMPYRA is contraindicated in patients with a prior history of seizure. Discontinue AMPYRA use if seizure occurs.
AMPYRA is contraindicated in patients with moderate or severe renal impairment (CrCl≤50 mL/min); the risk of seizures in patients with mild renal impairment (CrCl 51–80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating treatment with AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.
Urinary tract infections were reported more frequently as adverse reactions in patients receiving AMPYRA 10 mg twice daily compared to placebo.
The most common adverse events (incidence ≥2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.
For full U.S. Prescribing Information and Medication Guide for AMPYRA, please visit: www.AMPYRA.com.
About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and other nervous system disorders. The Company's marketed products include AMPYRA™ (dalfampridine), a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS); this was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.
About NORD
The National Organization for Rare Disorders (NORD) was established in 1983. It is a nonprofit organization representing all Americans affected by rare diseases. NORD's services include advocacy on public policy issues; education and information for patients, families, medical professionals, and the public; patient assistance programs to help patients obtain certain medications they could not otherwise afford; mentoring for other patient organizations; and research grants and fellowships. NORD's website is at www.rarediseases.org.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Ampyra in the United States and to successfully market Zanaflex Capsules, the risk of unfavorable results from future studies of Ampyra, the occurrence of adverse safety events with our products, delays in obtaining or failure to obtain regulatory approval of Ampyra outside of the United States and our dependence on our collaboration partner Biogen Idec in connection therewith, competition, failure to protect Acorda Therapeutics’ intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from our preclinical programs. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
CONTACT:
Acorda Therapeutics
Jeff Macdonald, 914-347-4300 ext. 232
[email protected]
KEYWORDS: United States North America New York
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical FDA
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