Ongentys Approved in Japan as Levodopa Add-on Therapy for ‘Off’ Periods

Ongentys (opicapone) has been approved in Japan as an oral, add-on daily treatment for Parkinson’s disease patients experiencing off periods while on a levodopa/carbidopa regimen.

This decision adds Japan to the list of countries where Ongentys is available as an add-on treatment for Parkinson’s motor symptoms, including the U.S. and the European Union. The U.S. Food and Drug Administration (FDA) approved Ongentys in April 2020, and the therapy has been available in Europe 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/carbidopa regimen, 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 Parkinson’s. However, patients often experience fluctuations in their motor symptoms as their disease progresses, due to a wearing of the therapy’s effectiveness over time.

Levodopa can be converted to dopamine, the neurotransmitter that is gradually lost in Parkinson’s 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 treatment’s 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 medication’s 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 by Neurocrine Biosciences across North America; in Europe, it is marketed by Bial.