Dalfampridine ER Tablets, Generic Version of Ampyra, Now Available in US, Mylan Announces

Mylan announced its U.S. launch of dalfampridine extended-release (ER) tablets, the authorized generic version of Acorda‘s Ampyra, that work to improve walking abilities in adults with multiple sclerosis (MS). Both versions of this medication come in a 10 mg tablet form.

Approved generic medicines are those that have been proven to be “bioequivalent” to their brand-name counterparts in terms of strength, dosage, quality, safety, and efficacy. Generics have the same active ingredients as brand-name medicines, and work in the same way. A major advantage is their cost-effectiveness: they are less expensive because their makers don’t face the same development costs as manufacturers of brand-name drugs.

Dalfampridine was approved in 2010 by the U.S. Food and Drug Administration (FDA) to improve walking abilities in patients with MS.

Data from clinical trials, including longer-term data, has shown that dalfampridine can significantly improve walking speed and distance, as well as gait and balance.

In particular, results of the Phase 3 clinical trial (NCT01328379) reported that the use of dalfampridine 10 mg “was associated with statistically significant and clinically meaningful improvements in walking relative to placebo” and that “the 10-mg BID [twice a day] dose is effective for improving walking speed, as observed on short timed-walk tests, and for increasing distance walked over longer timed-walk periods,” researchers wrote in a study reporting the findings.

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Both Ampyra and Mylan’s generic formulation block potassium channels on the surface of nerve fibers; this is thought to improve the conduction of signals along nerve fibers whose insulating myelin coating has been damaged by MS.

Side effects of the drug include shortness of breath or trouble breathing, swelling of throat or tongue, or hives.

The medication can cause seizures and should not be taken by people who have ever had a seizure, have certain types of kidney problems, or are allergic to dalfampridine, the active ingredient in Ampyra extended-release tablets and the dalfampridine ER tablets.

“The launch of Dalfampridine Extended-Release Tablets is yet another example of Mylan’s continued commitment to providing access for patients living with multiple sclerosis, and adds to our portfolio of products indicated for the disease or its related conditions,” Heather Breschs, Mylan CEO, said in a press release.

Dalfampridine generic launch in the U.S. was possible after the Court of Appeals for the Federal Circuit in September supported the decision of the U.S. District Court for the District of Delaware to invalidate four Ampyra patents held by Acorda.