Yesterday, Adamas Pharmaceuticals, Inc. announced the full commercial launch of Gocovri (amantadine) extended release capsules, its flagship product for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
The drug was approved by the U.S. Food and Drug Administration (FDA) in August
, and has been available for patient and physician use since October. With the approval came7 years of orphan drug exclusivity. Though amantadine is a weak N-Methyl-D-aspartate (NMDA) antagonist, it has exhibited the ability to increase the release of dopamine, and block dopamine reuptake in this patient population.
Parkinson’s disease is a neurodegenerative disorder resulting from a loss of dopaminergic neurons in the brain. While the condition itself is not rare, the dyskinesia that develops in patients receiving the current standard-of-care, levodopa, is qualified as a rare disease in the United States, as it affects less than 200,000 people.
“The full commercial launch of Gocovri represents an important milestone for Adamas and will significantly expand awareness of Gocovri for both physicians and patients,” said Gregory T. Went, Ph.D., Founder, Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. in a press release
. “We are pleased with the early interest in Gocovri, as at least 100 distinct physicians and other healthcare professionals have already prescribed Gocovri to their patients, with access support provided to eligible patients through Gocovri Onboard, our patient services support program.”
Gocovri is a high-dose 274 mg amantadine (340 mg amantadine hydrochloride) to be taken once-daily at bedtime, which will deliver consistently high levels of amantadine in the morning and throughout the day. The approval was based on data from 2 Phase 3 clinical trials showing the drug to significantly reduce Unified Dyskinesia Rating Scal (UDysRS) total scores. Further, the drug was proven to reduce “off time,” or periods of the day when levodopa is not effective, by approximately 60 minutes.
“The launch of Gocovri, which was demonstrated in clinical studies to reduce both dyskinesia and off time, gives physicians a new tool for the treatment of Parkinson’s disease patients with dyskinesia,” said Dr. Rajesh Pahwa, Professor of Neurology and Chief, Parkinson’s Disease Center, University of Kansas Medical Center, Kansas City. “I believe Gocovri also represents a broad, comprehensive scientific approach to treating Parkinson’s disease based on Adamas’ focus and understanding of the time-dependent aspects of Parkinson’s disease symptoms and the intrinsic role of the glutamate pathway in Parkinson’s disease versus the more commonly addressed dopaminergic pathway.”
In addition to the official launch of the product, Adamas has also announced the start of Gocovri Onboard, a patient assistance program that intends to facilitate access to, and distribution of the medicine. The program will work with patients, their families and physicians to obtain access to Gocovri, via reimbursement support, prescription fulfillment and financial assistance to patients in need.
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