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Ed. Note: The following
story is a press release from Acorda Therapeutics. April
4, 2005 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
http://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 (http://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
http://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.
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