HAWTHORNE, N.Y.–(BUSINESS WIRE)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: ELN) in July 2004. Elan will manufacture ZANAFLEX(R) CAPSULES for Acorda at its Athlone, Ireland facility.
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 (SCI) and Multiple Sclerosis (MS). More than 500,000 people in the United States suffer from spasticity.
“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 products in our pipeline,” said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer.
About ZANAFLEX(R) CAPSULES
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.
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.
“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.
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.
Safety Information
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.
In three multiple dose, placebo controlled studies, the most frequently reported adverse events included dry mouth (49%), somnolence (48%), 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 (3%) were reported. In a single-dose study where patients were not titrated, 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 CYP450 enzyme system.
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, 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.
For full prescribing information, please go to www.zanaflexcapsules.com.
About Spasticity
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. 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.
About Acorda Therapeutics
Acorda Therapeutics, a privately-held Biotechnology company, is developing therapies for SCI, MS and related nervous system disorders. 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, 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.
About Elan’s Global Services and Operations
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.
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 is a primary site for the utilization of Elan’s proprietary NanoCrystal(R) technology, an innovative approach for delivering poorly water-soluble compounds.
Contacts
Acorda Therapeutics
Tierney Saccavino, 914-347-4300, ext. 104
