| Acorda Therapeutics®
was established in March 1995 to develop therapies
that restore neurological function to people with
spinal cord injury (SCI), multiple sclerosis (MS)
and related conditions of the nervous system.
Product Pipeline: Marketed Products
Acorda’s products, Zanaflex Capsules®
and Zanaflex® tablets, are FDA-approved for
the management of spasticity, a symptom of conditions
such as MS and SCI that is commonly characterized
by stiffness or rigidity, restriction of movement
and painful muscle spasms. Zanaflex Capsules and
Zanaflex tablets contain tizanidine hydrochloride,
or tizanidine, one of the two leading treatments
currently used for the management of spasticity.
Zanaflex Capsules are available in 2mg, 4mg and
6mg doses, while tablet formulations are only available
in 2mg and 4mg doses. The most frequent adverse
events associated with the use of tizanidine are
dry mouth, drowsiness, fatigue, and dizziness. These
events are generally mild to moderate and are believed
to be dose-related.For
full prescribing information, please click here.
Product Pipeline: Clinical Stage
In June 2008, Acorda announced positive results from its second positive Phase 3 clinical trial of Fampridine-SR on walking ability in people with MS.
Fampridine has also been studied in SCI. On May 6, 2009 Acorda announced that the U.S. Food and Drug Administration (FDA) accepted the Fampridine-SR New Drug Application (NDA) for filing, assigning Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009. The PDUFA date is the target date for the FDA to complete its review of the Fampridine-SR NDA.
Acorda has three preclinical programs focused on
novel approaches to repair damaged components of
the CNS.
- Chondriotinase – This program is based
on the concept of breaking down the matrix of
scar tissue that develops as a result of an injury
to the CNS. Published research has demonstrated
that this scar matrix is partly responsible for
limiting the regeneration of nerve fibers in the
CNS and restricting their ability to modify existing
neural connections. Independent academic laboratories
have also published animal studies showing that
application of chondroitinase results in recovery
of function following injuries to various areas
of the brain and spinal cord.
- Neuregulins – This program is based on
using GGF-2, a neuregulin growth factor to stimulate
remyelination, or repair of the myelin sheath.
In published studies, GGF-2 has been shown to
stimulate remyelination in animal models of MS
and to have other effects in neural protection
and repair.
- Remyelinating antibodies – This program
is based on more than 15 years of research performed
at the Mayo Clinic. Studies have demonstrated
the ability of this family of antibodies to stimulate
remyelination in three different animal models
of MS.
Core technologies developed by Acorda for SCI and
MS have potentially broad applicability for other
neurologic conditions. Focusing on these conditions
provides insight into chronic and acute CNS conditions
– for example, MS represents a chronic degeneration
of the CNS, whereas SCI represents an acute CNS
injury followed by a relatively stable chronic condition.
In addition, many of the mechanisms of secondary
tissue damage and potential repair in MS and SCI
are shared with other conditions, including stroke
and traumatic brain injury. The functional deficits
and symptoms suffered by MS and SCI patients, such
as walking impairments, spasticity and loss of bladder
and bowel function, are also shared by other CNS
disorders.
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