Bial is pleased to announce that OngentysÂ® (opicapone) is now available as of January 1, 2022 for adult patients with Parkinsonâ€™s Disease as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) with end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Parkinsonâ€™s Disease is a chronic and slowly progressive neurodegenerative disorder that affects an estimated 12,000 people in Ireland.
OngentysÂ® offers a low frequency dosing treatment in patients that have failed in their current oral regimen. Prior to this approval, some of these patients would have required more invasive therapies such as injection, infusion or pump to manage their condition if other treatments failed.
â€œOngentys is a new treatment option that decreases â€˜offâ€™ time â€“ the period of time during the day when Parkinsonâ€™s disease symptoms are troublesome â€“ and increases â€˜onâ€™ time without troublesome dyskinesia, the period of time during the day when Parkinsonâ€™s disease symptoms are better controlled,â€ said Professor Tim Lynch, Consultant Neurologist and Clinical Director of the Dublin Neurological Institute at the Mater University Hospital.
â€œThe approval of Ongentys is welcome news to people in Ireland with Parkinsonâ€™s Disease who are looking for additional pharmacological possibilities to help control the often-difficult symptoms of the disease that negatively impact their lives.â€
OngentysÂ® is a once-a-day oral COMT (Catechol-O-methyltransferase) inhibitor which can block COMT, an enzyme that breaks down levodopa, which is the gold standard therapy for controlling motor symptoms in patients with Parkinsonâ€™s Disease. OngentysÂ® can reduce the symptoms of Parkinsonâ€™s Disease by helping to protect levodopa against this enzyme by reducing its breakdown in the bloodstream, making more levodopa available to reach the brain.
The approval of OngentysÂ® is supported by data from two multinational Phase III clinical studies (BIPARK I and BIPARK II). In BIPARK I, approximately 600 patients with Parkinsonâ€™s Disease and motor fluctuations received one of three doses of OngentysÂ® (5mg, 25mg or 50mg), placebo or 200mg doses of the COMT inhibitor entacapone for 14 or 15 weeks. In the BIPARK II trial, approximately 400 patients received one of two doses of OngentysÂ® (25mg or 50mg) or placebo for 14 or 15 weeks. The data from both trials showed that OngentysÂ® 50mg significantly reduced OFF time from baseline to week 14 or 15 compared to placebo.
For more see: www.bial.com.