FDA approves the launch of Parkinson ’s new drug Opicapone

Recently, Neurocrine Biosciences announced that the US FDA has approved Opicapone (trade name Ongentys®) as an adjuvant therapy for levodopa / carbidopa to treat patients with Parkinson's disease who have experienced an "off" period. As the disease progresses, patients taking levodopa / carbidopa may experience an “off” period between treatments, during which the incidence of motor symptoms such as tremor, slow movement, and difficulty walking in Parkinson ’s patients may increase. Opicapone can also increase the patient's "on" period (on time), that is, the period of time when the drug takes effect and the patient's symptoms are controlled, without causing dyskinesia, which can better control the movement symptoms of patients with Parkinson's disease .


Ongentys® is a new, once-daily, oral, selective, reversible catechol oxygen methyltransferase (COMT) inhibitor. The capsule is available in two sizes, 25mg and 50mg. This variety can be used as an adjuvant therapy for levodopa / carbidopa in patients with Parkinson's disease who have undergone an "off" period. Ongentys® inhibits the COMT enzyme, which breaks down levodopa, allowing more levodopa to reach the brain.


The breed was originally launched in the European Union in June 2016. In 2017, Neurocrine Biosciences obtained the exclusive development and commercialization rights of Opicapone in the United States and Canada from the Portuguese pharmaceutical company BIAL. In January 2018, Fosun Pharma obtained the exclusive rights of Opicapone in the Chinese market with a license of US $ 18 million from BIAL. In March 2019, Fosun Pharma submitted a clinical application for opicapone's new drug in China and was accepted by CDE.


Parkinson's disease is the second most common neurodegenerative disease in the United States after Alzheimer's disease. There are more than 6 million Parkinson's patients worldwide and more than 1 million in the United States. Parkinson's is caused by low levels of dopamine in the patient's brain. As Parkinson's disease progresses, the production of dopamine decreases steadily, leading to increased motor symptoms, including slow movement, tremor, and impaired balance. There is currently no cure for Parkinson's disease. The disease management mainly uses dopamine mechanisms to control motor symptoms. The current gold standard therapy for sports symptoms is levodopa / carbidopa. Levodopa / carbidopa can improve the patient's motor symptoms, but as the disease progresses, the beneficial effects of levodopa begin to disappear more quickly, then, the patient will "open" time (the drug is effective) and "close" "Movement fluctuations are experienced throughout the day between time (drug ineffective).


The approval of Ongentys® is supported by data from 38 clinical studies, including two cross-border Phase III clinical studies (BIPARK-1 and BIPARK-2), involving more than 1,000 patients with Parkinson's disease receiving Ongentys®. Both studies include a one-year open label expansion period. The trial data showed that 50 mg of Ongentys® significantly shortened the "off" period of time compared to the placebo compared with placebo, and the "on" period of normal exercise capacity also increased significantly from the baseline.


"The US FDA approved the listing of Ongentys®, which provides an important new treatment option for patients with Parkinson's disease. Ongentys® can reduce the onset of the" closed "period and increase the time of the" opened "period to help control unpredictable movement fluctuations. "Dr. Kevin C. Gorman, CEO of Neurocrine Biosciences, said," At Neurocrine Biosciences, our mission is to alleviate the suffering of patients. We look forward to working with Parkinson's disease organization to provide this new therapy to patients later this year . "