Adamas Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Gocovri (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Gocovri , previously granted orphan drug status by the FDA, is the first and only medicine approved by the FDA for this indication.
“Gocovri’s approval is an important advancement for the treatment of Parkinson’s disease, as it is the first FDA-approved medicine for the treatment of dyskinesia in Parkinson’s disease patients,” said Rajesh Pahwa, M.D., Laverne & Joyce Rider Professor of Neurology at the Kansas Medical Center and Director, Parkinson’s Disease Center of Excellence at the University of Kansas Health System. “Notably, Gocovri is the first Parkinson’s disease medicine proven in controlled trials to reduce both dyskinesia and OFF time in Parkinson’s disease patients receiving levodopa. Treatment of dyskinesia and OFF time continues to be an unmet need in the medical management of Parkinson’s disease and the approval of Gocovri is a major step in that direction.”
Gocovri is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs. Dyskinesia is a consequence of levodopa-based Parkinson’s disease treatment and is characterized by involuntary and non-rhythmic movements that are purposeless and unpredictable, which impact the activities of daily living.
“Dyskinesia can significantly compromise quality of life for people with Parkinson’s disease,” said Dr. Todd Sherer, Chief Executive Officer of The Michael J. Fox Foundation for Parkinson’s Research. “We are pleased that patients have another option to manage this aspect of the disease and glad the Unified Dyskinesia Rating Scale – a tool our support helped develop and validate – could show clinical efficacy of Gocovri for the treatment of dyskinesia.”
Gocovri’s positive benefit/safety profile was established in two Phase 3 controlled clinical trials in Parkinson’s disease patients with dyskinesia. In Study 1, patients treated with Gocovri demonstrated statistically significant and clinically relevant reductions in dyskinesia, with a 37 percent reduction in Unified Dyskinesia Rating Scale (UDysRS) total score vs. 12 percent for placebo at Week 12. These results were confirmed in Study 2 in which Gocovri achieved a 46 percent reduction in UDysRS vs. 16 percent for placebo. Additionally, key secondary data from Parkinson’s disease patient reported diaries in Study 1 and Study 2 respectively, showed that Gocovri -treated patients experienced a 3.6 and 4.0 hour increase in functional time daily (defined as ON time without troublesome dyskinesia) vs. a 0.8 and 2.1 hour increase for placebo-treated patients at Week 12. The increases in functional time were achieved by decreases in both ON time with troublesome dyskinesia and OFF time. The placebo-adjusted reduction in OFF time in both studies was approximately 1 hour per day. The most commonly observed adverse reactions ( > 10 percent and greater than placebo) with Gocovri were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For additional Important Safety Information, see below.
“Today’s approval is a tremendous milestone for Adamas and for the Parkinson’s disease community,” said Gregory T. Went, Ph.D., Founder, Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “Gocovri has the potential to help people with Parkinson’s disease suffering from dyskinesia by finally providing physicians with an effective tool to address this long-standing unmet medical need. We thank the physicians, clinical staff, patients and their families who participated in the clinical trials for making this advancement possible for the community.”
Gocovri is expected to be available in the fourth quarter, and formally launched with the full deployment of Adamas’s sales force in January 2018. Adamas developed Gocovri for people with Parkinson’s disease and the company is committed to helping them gain access. Adamas has created “Gocovri Onboard,” a patient services program, which will facilitate access and distribution. “Gocovri Onboard” will work with patients, their families and physicians to obtain access to Gocovri via reimbursement support, prescription fulfillment and financial assistance. “Gocovri Onboard” is designed to deliver dedicated assistance and financial support to patients in need.
Filed Under: Drug Discovery