The decision came after the company reviewed findings from a comprehensive analysis of its Phase 3 INROADS trial (NCT03436199), which assessed the safety and efficacy of ADS-5102 in 594 MS patients with walking impairments.
According to the company, this analysis was in agreement with top-line study data announced last year, showing an improvement in walking speeds of about 20% in those randomized to daily ADS-5102, an extended release capsule treatment, compared with placebo. But these gains were of low magnitude, rather than the degree anticipated.
These findings, in turn, necessitated a reconsideration of the treatment’s likely profile if approved, which — based on feedback from patients and physicians — “projected a limited commercial opportunity,” Adamas stated in a press release.
Discussions with the U.S. Food and Drug Administration (FDA) also confirmed that an additional Phase 3 trial would be required to support an application requesting ADS-5102’s approval in MS.
Despite choosing not to pursue further studies, Adamas said it will complete INROADS’ open-label extension trial (NCT03567057), due to end in January 2021. Here, all who finished the original study are being treated with ADS-5102 capsules for up to one year.
“As a patient focused company this was a difficult decision, and I want to thank the patients, healthcare professionals, and employees who contributed to this development program. There remains a significant unmet need for this population and we are committed to completing the open-label study and publishing our data to benefit the MS community,” Neil F. McFarlane, the company’s CEO, said in the release.
An extended-release capsule taken before bedtime, Gocovri is the only medication to date shown to reduce both dyskinesia and the duration of “off periods” — times during which levodopa-based treatments cease to be effective at keeping the motor symptoms of Parkinson’s at bay — rather than requiring a trade-off between these two treatment goals.
In June, Adamas submitted a supplemental new drug application to the FDA, asking that Gocovri also be approved as an off episodes treatment for Parkinson’s patients using levodopa.
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