|AMPYRA® Two-Year Safety Data Presented at 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)|
- Two-year data from more than 62,400 people with multiple sclerosis highlight AMPYRA safety profile
This analysis was presented at the 28th
The analysis examined all post-marketing adverse events (AEs) that were
reported to Acorda and the
“AMPYRA has been available for over two years in
This poster presentation was sponsored by
Important Safety Information
Do not take AMPYRA if you have ever had a seizure or have certain types of kidney problems.
Take AMPYRA exactly as prescribed by your doctor.
You could have a seizure even if you never had a seizure before. Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50.
Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking AMPYRA.
AMPYRA may cause serious allergic reactions, including rare occurrence of anaphylaxis.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.
The most common adverse events for AMPYRA in MS patients were urinary tract infection, trouble sleeping, dizziness, headache, nausea, weakness, back pain, and problems with balance.
Before taking AMPYRA tell your doctor if you are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You and your doctor should decide if you will take AMPYRA or breast-feed. You should not do both.
You are encouraged to report negative side effects of prescription drugs
Acorda markets AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in
The Company also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity. Acorda
also receives sales royalties on tizanidine hydrochloride capsules, an
authorized generic version of ZANAFLEX CAPSULES distributed by
Acorda is developing an industry-leading pipeline of novel neurological therapies. The Company is studying AMPYRA to improve a range of functional impairments caused by MS, as well as its use in other neurological conditions, including cerebral palsy and post-stroke deficits. In addition, Acorda is developing clinical stage compounds AC105 for acute treatment of spinal cord injury and GGF2 for treatment of heart failure. GGF2 is also being investigated in preclinical studies as a treatment for neurological conditions such as stroke and spinal cord injury. Additional preclinical programs include rHIgM22, a remyelinating monoclonal antibody for the treatment of MS, and chondroitinase, an enzyme that encourages nerve plasticity in spinal cord injury.
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 our ability to successfully market and sell Ampyra in the
U.S.; third party payers (including governmental agencies) may not
reimburse for the use of Ampyra at acceptable rates or at all and may
impose restrictive prior authorization requirements that limit or block
prescriptions; the risk of unfavorable results from future studies of
Ampyra or from our other research and development programs, including
any acquired or in-licensed programs; the occurrence of adverse safety
events with our products; delays in obtaining or failure to obtain
regulatory approval of or to successfully market Fampyra outside of the
U.S. and our dependence on our collaboration partner Biogen Idec in
connection therewith; competition, including the impact of generic
competition on Zanaflex Capsules revenues; failure to protect our
intellectual property, to defend against the intellectual property
claims of others or to obtain third party intellectual property licenses
needed for the commercialization of our products; failure to comply with
regulatory requirements could result in adverse action by regulatory
agencies; and the ability to obtain additional financing to support our
operations. These and other risks are described in greater detail
in Acorda Therapeutics' filings with the
Acorda Therapeutics, Inc.