Adamas Pharmaceuticals’ Gocovri™ (amantadine) extended-release capsules (previously ADS-5102) won FDA approval as the first drug cleared for treating dyskinesia in Parkinson’s disease (PD) patients who are receiving levodopa-based therapy, with or without concomitant dopaminergic drugs. The once-daily high-dose amantadine is taken at bedtime and is designed to deliver consistently high levels of amantadine throughout the day.
“Gocovri’s approval is an important advancement for the treatment of PD, as it is the first FDA-approved medicine for the treatment of dyskinesia in PD patients,” said Rajesh Pahwa, M.D., Laverne & Joyce Rider Professor of Neurology at the Kansas Medical Center, and director of the Parkinson’s Disease Center of Excellence at the University of Kansas Health System. “Notably, Gocovri is the first PD medicine proven in controlled trials to reduce both dyskinesia and OFF time in PD patients receiving levodopa.”
Approval of Gocovri was based on two Phase III studies, which confirmed that patients receiving the drug demonstrated 37%, and 46% average reductions in the Unified Dyskinesia Rating Scale (UDysRS) total score, compared with 12%, and 16%, reductions in UDysRS, respectively, for placebo-treated patients. Gocovri-treated patients in the two trials also reported experiencing 3.6 hours and 4.0 hours, respectively, increased functional time daily, which is defined as ON time without troublesome dyskinesia. The average increase in functional time daily among placebo-treated patients in the first, and second trials, was 0.8, and 2.1 hours. The placebo-adjusted reduction in OFF time in both studies was approximately 1 hour per day.
Adamas projects that Gocovri will be available during Q4 2017, and full-scale launch will follow in January 2018. The firm has created the Gocovri Onboard patient services program to facilitate access and distribution to the drug.
Adamas is developing a pipeline of drugs for treating chronic neurological disorders, including multiple sclerosis and epilepsy. The firm is separately developing ADS-5102 for treating walking impairment in patients with multiple sclerosis and is considering other potential applications for the drug, including walking impairment in stroke patients, side effects induced by antipsychotic drugs, and additional PD indications.
Adamas is separately developing ADS-4101, a high-strength, once-daily formulation of the marketed antiepilepsy drug lacosamide therapy, for treating partial onset seizures in epilepsy patients. ADS-4101 is designed to be taken at bedtime and deliver high concentrations of lacosamide during the day when seizures primarily occur. Positive data from a Phase Ia study were reported at the 14th Antiepileptic Drug and Device Trials Conference in June. Phase Ib evaluation is ongoing.
Adamas is also developing its ADS-8800 platform, which comprises multiple fixed-dose combinations of ADS-5102, ADS-4101, and other single agents.
In March, FDA approved Newron Pharmaceuticals’ Xadago® (safinamide) as an add-on therapy to levodopa-carbidopa. At the time, the firm said the drug was the first new chemical entity approved for treating PD in the U.S. in more than a decade. Xadago was cleared by the European Commission back in 2015.
Just last month Mitsubishi Tanabe reported a deal to acquire PD drugs firm NeuroDerm for $1.1 billion.