Acorda's Ampyra in Phase III for Post-Stroke Walking Deficit - Analyst Blog

Acorda Therapeutics, Inc. (ACOR) enrolled the first patient in a phase III study on Ampyra (dalfampridine). Acorda is developing a twice-daily formulation of Ampyra for the treatment of post-stroke walking deficits (PSWD).

The multi-center, double-blind, randomized phase III study will evaluate the safety and tolerability of Ampyra in approximately 540 patients who have experienced an ischemic stroke at least six months before enrollment. Patients will be administered either Ampyra (10 mg/7.5 mg) or placebo twice daily for a period of 12 weeks. The primary endpoint of the phase III study is an improvement of at least 20% in the 2 minute walk test (2MinWT) compared to placebo.

We are encouraged by Acorda's efforts to expand Ampyra's label. According to the press release issued by Acorda, around 800,000 new cases of stroke occur in the U.S. annually, of which 3.5 million stroke survivors suffer from mobility issues. Once approved, the new medication will provide significant benefit to patients suffering from PSWD considering the lack of approved treatments.

We note that Ampyra (10 mg) is currently approved in the U.S. for the improvement of walking in multiple sclerosis patients. Ampyra is available outside the U.S. under the trade name Fampyra. Acorda has a licensing agreement with Biogen (BIIB) for Fampyra in markets outside the U.S.

Meanwhile, Acorda continues to progress with its pipeline. Last week, Acorda commenced a phase III study on CVT-301, which is being evaluated for the treatment of OFF episodes in Parkinson's disease patients. We remind investors that CVT-301 became a part of Acorda's pipeline following its Oct 2014 acquisition of Civitas Therapeutics.

We expect investor focus to remain on pipeline updates from the company.

Acorda currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen Inc. (AMGN), ANI Pharmaceuticals, Inc. (ANIP) and Biogen. All three carry a Zacks Rank #1 (Strong Buy).