Acorda Therapeutics Inc (fka ACORQ)

[surf1944]

6:05AM Acorda Therapeutics announces positive AMPYRA (dalfampridine) Phase 2 data in people with post-stroke deficits (ACOR) 31.52 : Co announced that a proof-of-concept trial found dalfampridine extended release tablets, marketed as AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, improved walking in people with post-stroke deficits. Post-stroke deficits refer to chronic neurological deficits, such as impaired walking, motor and sensory function and manual dexterity that persist in people who have had a stroke. The safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in multiple sclerosis. The most common adverse events reported in the study were dizziness (10.4% dalfampridine-ER, 2.5% placebo), nausea (3.9% dalfampridine-ER, 6.2% placebo), fatigue (5.2% dalfampridine-ER, 3.7% placebo), insomnia (5.2% dalfampridine-ER, 2.5% placebo) and arthralgia (2.6% dalfampridine-ER, 3.7% placebo). Improvement in walking was measured by the Timed 25-Foot Walk. Using the full crossover design, walking speed increased while participants were taking dalfampridine-ER compared to placebo (p < 0.05). Participants also showed a positive change on the Functional Independence Measurement (FIM) scale while taking dalfampridine-ER compared to placebo. The FIM scale assesses an individual's ability to perform daily tasks such as bathing, grooming, eating, and walking independently.

A separate proof-of-concept trial including 24 participants explored the use of dalfampridine-ER 10 mg dosed twice daily in adults with cerebral palsy (CP). The safety findings in this study were consistent with previous clinical trials and post-marketing experience of AMPYRA in MS. The most commonly reported adverse events were headache (12.5% dalfampridine-ER, 4.2% placebo), fatigue (12.5% dalfampridine-ER, 0% placebo), insomnia (8.3% dalfampridine-ER, 4.2% placebo), diarrhea (4.2% dalfampridine-ER, 4.2% placebo) and nausea (4.2% dalfampridine-ER, 4.2% placebo). There were no serious adverse events reported. Efficacy data from this study suggested potential treatment activity on measures of walking and hand strength; however, these data are still being analyzed to determine if they are sufficiently robust to warrant further clinical studies. The co plans to present data from the post-stroke deficits and CP trials in appropriate medical forums following additional analysis of the data.