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Acorda Therapeutics Launches ZANAFLEX CAPSULES for the Management of Spasticity in People with MS and Spinal Cord Injury.


HAWTHORNE, N.Y. -- Acorda Therapeutics(R) announced today that it has launched ZANAFLEX(R) CAPSULES (tizanidine hydrochloride), a new, capsule formulation of tizanidine, a leading treatment for spasticity in the United States. Acorda acquired ZANAFLEX(R) CAPSULES and ZANAFLEX(R) (tizanidine hydrochloride) tablets from Elan Corporation, plc (NYSE NYSE

See: New York Stock Exchange
: ELN Noun 1. ELN - a Marxist terrorist group formed in 1963 by Colombian intellectuals who were inspired by the Cuban Revolution; responsible for a campaign of mass kidnappings and resistance to the government's efforts to stop the drug trade; "ELN kidnappers target ) in July 2004. Elan will manufacture ZANAFLEX(R) CAPSULES for Acorda at its Athlone, Ireland facility. E[acute accent]ZANAFLEX(R) CAPSULES are a short-acting drug for the management of spasticity. Spasticity refers to the often painful involuntary tension, stiffening or contractions of muscles that results from neurological conditions such as spinal cord injury Spinal Cord Injury Definition

Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control.
Description

Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States.
 (SCI (Scalable Coherent Interface) An IEEE standard for a high-speed bus that uses wire or fiber-optic cable. It can transfer data up to 1GBytes/sec.

(hardware) SCI - 1. Scalable Coherent Interface.

2. UART.
) and multiple sclerosis (MS). More than 500,000 people in the United States suffer from spasticity. E[acute accent]"ZANAFLEX(R) CAPSULES represent an ideal strategic fit with Acorda's existing expertise in, and commitment to, the MS and SCI communities. In addition, the commercial capabilities Acorda is developing with the launch of ZANAFLEX(R) CAPSULES will be invaluable as we move towards the launch of other CNS See Continuous net settlement.

CNS

See continuous net settlement (CNS).
 products in our pipeline," said Ron Cohen cohen
 or kohen

(Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male.
, M.D., Acorda's President and Chief Executive Officer.

E[acute accent]About ZANAFLEX(R) CAPSULES

E[acute accent]ZANAFLEX(R) CAPSULES are available in 2 mg, 4 mg and a new, 6 mg strength. The 6 mg dose is only available in the capsule formulation. This formulation can provide physicians and patients new dosing options and added convenience, while retaining the efficacy and safety of ZANAFLEX(R) tablets. E[acute accent]In clinical studies, ZANAFLEX(R) was shown to significantly reduce excessive muscle tone and spasms without reducing the function of healthy muscles. It is thought to reduce spasticity by blocking nerve impulses through pre-synaptic inhibition of motor neurons, resulting in decreased spasticity without a reduction in muscle strength. E[acute accent]"Spasticity is one of the most common disabilities associated with multiple sclerosis. ZANAFLEX(R) is a proven, effective treatment option for this serious medical condition and ZANALFEX(R) CAPSULES may offer additional flexibility and convenience for both doctors and patients," said Randall T. Schapiro, M.D, Founder and Director of the Schapiro Center for Multiple Sclerosis at the Minneapolis Clinic of Neurology, and Clinical Professor of Neurology at the University of Minnesota (body, education) University of Minnesota - The home of Gopher.

http://umn.edu/.

Address: Minneapolis, Minnesota, USA.
. E[acute accent]It is important to note that ZANAFLEX(R) CAPSULES are not therapeutically equivalent to tizanidine tablets. The new formulation has a different pharmacokinetic profile than the currently available tablets, and patients may experience the effects of the formulations differently, particularly when taken with food. Some patients may find capsules easier to take than tablets and, for patients who have an impaired ability to swallow, ZANAFLEX(R) CAPSULES offer the opportunity to sprinkle the particles in liquids or soft foods. In addition, the 6 mg dose, which is not available in the tablet form, may provide the opportunity for patients to take fewer pills per day.

E[acute accent]Safety Information

E[acute accent]ZANAFLEX(R) CAPSULES do not reduce muscle strength and are non-narcotic. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important. E[acute accent]In three multiple dose, placebo controlled studies, the most frequently reported adverse events included dry mouth (49%), somnolence somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess.

som·no·lence
n.
1. A state of drowsiness; sleepiness.

2.
 (48%), asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness.

neurocirculatory asthenia
 (weakness, fatigue, and/or tiredness) (41%), and dizziness (16%). Other adverse events reported across studies included elevated liver enzymes (5%). In two studies, hallucinations Hallucinations Definition

Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even
 (3%) were reported. In a single-dose study where patients were not titrated ti·trate  
tr. & intr.v. ti·trat·ed, ti·trat·ing, ti·trates
To determine the concentration of (a solution) by titration or perform the operation of titration.
, two-thirds of patients given 8 mg of Zanaflex experienced hypotension, which may be minimized by titration of dose. Zanaflex is not likely to affect the metabolism of other drugs metabolized by the CYP CYP

In currencies, this is the abbreviation for the Cyprus Pound.

Notes:
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion.
450 enzyme system. E[acute accent]Clearance of Zanaflex may be significantly reduced under the following conditions: in the elderly, in presence of renal or hepatic impairment, with concomitant use of fluvoxamine fluvoxamine /flu·vox·amine/ (floo-vok´sah-men) a selective serotonin reuptake inhibitor, used as the maleate salt to relieve the symptoms of obsessive-compulsive disorder. , ciprofloxacin, or oral contraceptives. Pharmacokinetic differences may result in clinically significant differences when switching formulations or changing administration during a fed or fasted state, and may be most prevalent when changing formulations from the capsule to the tablet in the fed state. E[acute accent]For full prescribing information, please go to www.zanaflexcapsules.com.

E[acute accent]About Spasticity

E[acute accent]Spasticity refers to the often painful involuntary tension, stiffening or contractions of muscles. This condition occurs when the nerve cells in the spinal cord become disconnected from controlling centers in the brain, and therefore transmit unregulated impulses to the muscles. Spasticity is common in neurological disorders where portions of the nervous system that control voluntary movement have been damaged, such as spinal cord injury (SCI), multiple sclerosis (MS), stroke and traumatic brain injury Traumatic brain injury (TBI), traumatic injuries to the brain, also called intracranial injury, or simply head injury, occurs when a sudden trauma causes brain damage. TBI can result from a closed head injury or a penetrating head injury and is one of two subsets of acquired brain . Up to 75% of people with chronic SCI, and the majority of people with MS, experience some form of spasticity. We Move (www.wemove.org) estimates that spasticity affects over half a million people in the United States alone, and over 12 million worldwide.

E[acute accent]About Acorda Therapeutics

E[acute accent]Acorda Therapeutics, a privately-held biotechnology company, is developing therapies for SCI, MS and related nervous system disorders Nervous system disorders

A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency
. Acorda's lead clinical-stage product is Fampridine-SR, which is being developed for both MS and SCI. The Company's pipeline includes valrocemide, which it is developing with Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in , Ltd., as well as a number of preclinical products for regeneration and repair of the spinal cord and brain. For more information about Acorda, please go to www.acorda.com.

E[acute accent]About Elan's Global Services and Operations

E[acute accent]Elan's Global Services & Operations (GS&O) business has principal manufacturing and development facilities located in Athlone, Ireland, where in 2004 the company completed a $178.0 million investment and commenced building a $42.0 million sterile fill finish facility. The Athlone campus-an FDA/European Medicines Agency-approved site-now comprises 421,400 square feet in total, of which 138,000 square feet has dedicated, fully-equipped current good manufacturing practices ("cGMP") compliant manufacturing capacity to manufacture two billion units annually. E[acute accent]The company also has a manufacturing, scale-up and development facility approved for the manufacture of controlled substances (through Schedule II), in Gainesville, Georgia. Elan's development and scale-up facility in King of Prussia, Pennsylvania For Kings of Prussia, see List of rulers of Prussia

King of Prussia is an unincorporated community in Upper Merion Township, Montgomery County, Pennsylvania, United States. As of the 2000 census, its population was 18,511.
 is a primary site for the utilization of Elan's proprietary NanoCrystal(R) technology, an innovative approach for delivering poorly water-soluble compounds.
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Publication:Business Wire
Geographic Code:4EUIR
Date:Apr 4, 2005
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