New drug for Parkinson's disease Gocovri approved by the FDA

Recently, the US FDA approved the new drug Gocovri (amantadine, amantadine, formerly known as ADS-5102) sustained release capsule from Adamas Pharmaceuticals for the treatment of dyskinesia in patients with Parkinson's disease treated with levodopa. This is the first and only FDA approved drug for this indication.

帕金森病新药Gocovri获FDA批准

Parkinson's disease is a chronic neurodegenerative disease caused by the loss of dopamine in the brain. Patients usually need to be treated with levodopa to replace the lost dopamine. Prolonged use of this drug can cause severely debilitating exercise capacity fluctuations. This volatility is divided into two phases—the patient's athletic ability is normal during the “on” period, and the patient's athletic ability is significantly reduced during the “closed” period, usually characterized by slow movement, stiffness, walking obstacles, tremors, and posture. Unstable. According to statistics, about 90% of patients who use levodopa have dyskinesia, which is involuntary, rhythmic, and unpredictable, which greatly affects patients' daily life. In the United States alone, approximately 150,000 to 200,000 Parkinson's patients are plagued by movement disorders.

Gocovri is a drug that has the potential to improve this condition. It contains a high dose (274 mg) of amantadine, which is administered once a day to provide a high level of amantadine for one day to treat dyskinesias that occur throughout the day.

帕金森病新药Gocovri获FDA批准

Adamas Pharmaceuticals' R&D pipeline for the treatment of chronic neurological diseases (Source: Adamas Pharmaceuticals)

The approval of Gocovri is based on data from two Phase 3 clinical trials. In the first trial, patients showed a significant reduction in dyskinesia during the 12-week course of treatment, with a 37% reduction in the Unipolar Dysfunction Rating Scale (UDysRS) score and a decrease of only 12% in the placebo group. This result was confirmed in the second trial. Patients receiving Goocovri had a 46% reduction in the UDysRS score, compared with a 16% decrease in the placebo group. In addition, in both trials, patients receiving Goocovri had a daily increase in functional time (meaning no dyskinesia) by 3.6-4 hours, while the placebo group only increased by 0.8-2.1 hours to reach a critical secondary endpoint. Common adverse reactions with Goocvri include hallucinations, dizziness, dry mouth, peripheral edema, and constipation.

"Gocovri's approval is a major advancement in the field of Parkinson's disease treatment. It is the first FDA-approved drug for the treatment of dyskinesia in patients with Parkinson's disease," Professor of Neurology at the University of Kansas Medical Center and University of Kansas Medical Dr. Rajesh Pahwa, Director of the Center for Excellence in Systemin Parkinson's Disease, said: "It is worth noting that Gocovri is the first in clinical trials to demonstrate a reduction in dyskinesia and 'shutdown' in patients with Parkinson's disease taking levodopa. Drugs. The treatment of dyskinesia and OFF time is still an unmet need in the medical management of Parkinson's disease. Gocovri's approval is an important step in this direction."

帕金森病新药Gocovri获FDA批准

Dr. Gregory Went, Founder, Chairman and CEO of Adamas Pharmaceuticals (Source: Cantor Fitzgerald)

“Today's approval is a huge milestone for the Adamas and Parkinson's disease groups,” said Dr. Gregory Went, founder, chairman and CEO of Adamas Pharmaceuticals. “Gocovri has the potential to help patients with Parkinson's disease suffering from movement disorders, and ultimately To provide doctors with an effective tool to address this long-standing unmet medical need. We thank doctors, clinical staff, patients and their families involved in clinical trials to make progress for this group possible."

Adamas Pharmaceuticals expects the drug to be available in the fourth quarter of this year and will begin full sales in January next year.

We congratulate the approval of this new drug and look forward to its listing to bring treatment options to people with Parkinson's disease afflicted with movement disorders and improve their quality of life.

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