Adamas Pharma bails on amantadine in MS patients with walking impairment

Citing “limited” commercial opportunity and the need to conduct another late-stage clinical trial, Adamas Pharmaceuticals (NASDAQ:ADMS) has decided to terminate development of ADS-5102 (amantadine) extended-release capsules for the treatment multiple sclerosis (MS) patients with walking impairment.

The company made the decision after a comprehensive analysis of results from the Phase 3 INROADS study that, it says, validated topline results reported in December 2019 and informed a revised target product profile reflecting the scale of clinical benefit observed in the trial. Additional research projected unattractive commercial prospects, however. Further engagement with the FDA confirmed the need for a new Phase 3 study.

The company markets amantadine extended-release capsules under the brand name Gocovri, approved in the U.S. in August 2017 for the treatment of dyskinesia in Parkinson’s disease (PD) patients. Its supplemental application seeking approval to treat OFF episodes in PD patients is currently under FDA review with an action date of February 1, 2021.

https://seekingalpha.com/news/3583962-adamas-pharma-bails-on-amantadine-in-ms-patients-walking-impairment