Ampyra (dalfampridine) can help multiple sclerosis patients walk: Acorda

Ampyra (dalfampridine), a new oral drug to help patients with multiple sclerosis walk has been approve in US.

Acorda Therapeutics, Inc, which developed Ampyra (dalfampridine) has received marketing approval from the U.S. Food and Drug Administration for the drug as an oral treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.

Ampyra (dalfampridine) can help all four major types of MS (relapsing remitting, secondary progressive, progressive relapsing and primary progressive).

Ampyra (dalfampridine) can be used alone or with existing MS therapies, including immunomodulator drugs.

“Walking impairment affects a large majority of people with MS, and we are very pleased that the FDA has approved a new treatment that addresses this aspect of the disease,” said John Richert, M.D., Executive Vice President for Research & Clinical Programs at the National Multiple Sclerosis Society.

Ampyra (dalfampridine) which was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which was previously called fampridine.

Ampyra (dalfampridine) was granted orphan drug status, which will provide seven years of market exclusivity for the drug.

Ampyra (dalfampridine) is administered as a 10 mg tablet twice daily, approximately 12 hours apart. The primary measure of efficacy in its two Phase 3 MS trials was walking speed (in feet per second) as measured by the Timed 25-foot Walk (T25FW), using a responder analysis. A responder was defined as a patient who showed faster walking speed for at least three visits out of a possible four during the double-blind period than the maximum speed achieved in the five non-double-blind, no treatment visits (four before the double-blind period and one after).

A significantly greater proportion of patients taking Ampyra (dalfampridine) 10 mg twice daily were responders compared to patients taking placebo, as measured by the T25FW.

During the double-blind treatment period, a significantly greater proportion of patients taking Ampyra (dalfampridine) 10 mg twice daily had increases in walking speed of at least 10%, 20%, or 30% from baseline, compared to placebo.

In both trials, the consistent improvements in walking speed were shown to be associated with improvements on a patient self-assessment of ambulatory disability, the 12-item Multiple Sclerosis Walking Scale (MSWS-12).

Acorda expects Ampyra (dalfampridine)  to be commercially available in the United States in March 2010.

Ampyra (dalfampridine) will be distributed exclusively through a network of specialty pharmacies and coordinated by Patient Support Services.

US FDA approved Ampyra with a risk evaluation and mitigation strategy (REMS) program comprising a medication guide and communication plan.

Ampyra (dalfampridine) will be marketed in the United States by Acorda’s established commercial organization, which successfully launched Zanaflex Capsules (tizanidine hydrochloride).

Under Acorda’s existing license and supply agreement with Elan Pharma International Limited, a subsidiary of Elan Corporation, plc , Ampyra will be manufactured by Elan Drug Technologies using one of their Oral Controlled Release Technologies, the Mxdas) (MatriX Drug Absorption System) technology.