Acorda Therapeutics Inc. recently announced results from a post-marketing commitment study evaluating a 5 mg dose of Ampyra (dalfampridine-ER) for improvement in walking in patients suffering from multiple sclerosis (MS). The study failed to meet the primary endpoint.
We note that Ampyra 10 mg is available in the US for improvement in walking in patients suffering from MS. The drug is marketed outside the US under the trade name of Fampyra by Biogen Idec Inc. (BIIB - Analyst Report) under a license agreement with Acorda.
The post-marketing commitment study was conducted with 430 patients who were randomized to receive placebo, 5 mg or the currently marketed dose of 10 mg of Ampyra, twice daily. The study was conducted to see whether a lower dose (5 mg) of Ampyra would be efficacious for treating MS-related walking impairment.
The study showed that Ampyra’s 10 mg dose is a safe and effective dosage, whereas the 5 mg dose failed to demonstrate efficacy over placebo on the primary and secondary measures.
The company intends to submit these results to the FDA. It remains to be seen whether Ampyra’s label will be updated to include the study data.
Apart from the post-approval commitment study on the usage of 5 mg dose of Ampyra, the company is conducting a proof-of-concept study in adults with cerebral palsy. Initial results from the study are expected to be out by the end of this year. Another proof-of-concept study of Ampyra in patients with post-stroke deficits was initiated in the second quarter of the year with initial results expected in early 2013.
Meanwhile, Acorda reported Ampyra sales of $66.3 million in the second quarter of 2012. The company expects Ampyra revenues in the range of $255 million–$275 million for 2012.
We currently have a Neutral recommendation on Acorda. Acorda carries a Zacks #3 Rank (short-term Hold rating).