Sanction comes with REMS program to educate patients on the risks of using higher than recommended doses.
Acorda Therapeutics received approval to market Ampyra™ in the U.S. to improve walking in patients with multiple sclerosis (MS). In clinical trials this oral treatment reportedly demonstrated efficacy in people with all four major types of MS.
The approval, reported late Friday, sent Acorda’s stock up to $28.12 by the end of trading last week. This marked a six-month high for the firm.
The FDA sanctioned Ampyra with a risk evaluation and mitigation strategy (REMS) program comprising a medication guide and communication plan. The goals of the communication plan are to inform patients about the serious risks associated with use of higher than recommended doses, including seizures.
Acorda expects the drug to be commercially available in the U.S. in March. It has seven years of market exclusivity under FDA’s orphan drug status. The company plans to double its field-based sales professionals to approximately 100 in time for the drug launch.
Under Acorda’s license and supply agreement with Elan Pharma, Ampyra will be manufactured by Elan Drug Technologies using one of its oral, controlled-release technologies, the MXDAS™ (matriX drug absorption system). Biogen Idec owns ex-U.S. marketing rights.
Ampyra, which was previously referred to as Fampridine-SR, is an extended-release formulation of dalfampridine (4-aminopyridine, 4-AP). It is administered as a 10 mg tablet twice daily, approximately 12 hours apart, alone or with existing MS therapies including immunomodulators.
“The approval of Ampyra marks an important milestone for the many people with MS who suffer walking impairment,” remarks Ron Cohen, M.D., president and CEO of Acorda Therapeutics. “Difficulty walking is often cited by those with MS as one of the most pervasive and challenging aspects of their disease.”
The primary measure of efficacy in two Phase III MS trials evaluating Ampyra was walking speed (in feet per second). 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 nondoubleblind, no-treatment visits.
Among patients taking Ampyra, 34.8% in trial 1 and 42.9% in trial 2 responded compared to 8.3% and 9.3% of patients taking placebo in trial 1 and 2, respectively. The increased response rate was observed across all four major types of MS. A significantly greater proportion of patients taking the drug increased their walking speed by at least 10%, 20%, or 30% from baseline compared to placebo.