Ongentys Approved in Japan to Help Treat Parkinson’s ‘Off’ Periods – Parkinson’s News Today

Ongentys(opicapone) has been approved in Japan as an oral, add-on daily treatment forParkinsons diseasepatients experiencing off periods while on alevodopa/carbidoparegimen.

This decision adds Japan to the list of countries where Ongentys is available as an add-on treatment for Parkinsons motor symptoms, including the U.S. and theEuropean Union. The U.S. Food and Drug Administration(FDA) approved Ongentys in April 2020, and the therapy has been available inEurope since July 2016.

The approval, which also includes the manufacturing of Ongentys, is for 25 mg capsules taken once a day. The medicine should be taken at least one hour before or after administration of levodopa/carbidoparegimen, and at least one hour before or after a meal.

The announcement was made by Ono Pharmaceutical, which acquired the rights for Ongentys in Japan from Bial in April 2013.

Levodopa is considered the gold standard treatment for Parkinsons. However, patients often experience fluctuations in their motor symptoms as their disease progresses, due to a wearing of the therapys effectiveness over time.

Levodopa can be converted to dopamine, the neurotransmitter that is gradually lost in Parkinsons patients. However, dopamine cannot cross the blood-brain barrier, a highly selective membrane that shields the central nervous system (brain and spinal cord) from circulating blood. Levodopa needs to enter the brain before being converted.

Ongentys is designed to prolong the treatments effectiveness by increasing the amount of levodopa reaching the brain. It does so by blocking an enzyme, called catechol-o-methyltransferase (COMT), that breaks down levodopa in the blood.

Approval was based on the results of the Phase 2 ONO-2370-02 study, conducted in Japan, in which Ongentys was found to be superior to placebo in reducing off periods times when a medications effects wear off before a new dose can be taken.

Enrolled participants were given Ongentys once daily, at a dose of either 25 or 50 mg, for 14 to 15 weeks, while continuing their levodopa/carbidopa regimen.

Results showed that, compared to placebo, both doses of Ongentys reduced off time periods after 12 weeks. Ongentys was also well tolerated with no new side effects being reported.

Ongentys is marketed byNeurocrine Biosciencesacross North America; in Europe, it is marketed byBial.

Patricia holds a Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She has also served as a PhD student research assistant at the Department of Microbiology & Immunology, Columbia University, New York.

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Ana holds a PhD in Immunology from the University of Lisbon and worked as a postdoctoral researcher at Instituto de Medicina Molecular (iMM) in Lisbon, Portugal. She graduated with a BSc in Genetics from the University of Newcastle and received a Masters in Biomolecular Archaeology from the University of Manchester, England. After leaving the lab to pursue a career in Science Communication, she served as the Director of Science Communication at iMM.

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Ongentys Approved in Japan to Help Treat Parkinson's 'Off' Periods - Parkinson's News Today