Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced that 50 mg capsules of ONGENTYS® (opicapone), the first and only FDA-approved once-daily catechol-O-methyltransferase (COMT) inhibitor, are now available by prescription in the United States. ONGENTYS was approved by the U.S. Food and Drug Administration (FDA) on April 24, 2020, as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes.
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Parkinson's disease is the second most common neurodegenerative disorder in the United States after Alzheimer's disease. About one million Americans have Parkinson's disease and each year, an estimated 50,000 people in the United States are newly diagnosed with this chronic, progressive and debilitating neurodegenerative disorder.
"ONGENTYS is a new treatment option that decreases 'off' time, the period of time during the day when Parkinson's disease symptoms are bothersome, and increases 'on' time without troublesome dyskinesia, the period of time during the day when Parkinson's disease symptoms are better controlled," said Rebecca Gilbert, M.D., Ph.D., Vice President and Chief Scientific Officer of the American Parkinson Disease Association. "The approval of ONGENTYS is welcome news to people with Parkinson's disease who are looking for additional medication possibilities to help control the often difficult symptoms of the disease that negatively impact their lives."
ONGENTYS is an oral, selective COMT inhibitor that helps block the COMT enzyme that breaks down levodopa, the gold standard therapy for controlling motor symptoms in patients with Parkinson's disease. ONGENTYS helps protect levodopa by reducing its breakdown in the bloodstream, making more levodopa available to reach the brain.
"Parkinson's disease is a progressive, debilitating condition where people often struggle to control motor fluctuations, impacting many aspects of their daily life," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. "The availability of ONGENTYS offers hope to patients by significantly reducing daily 'off' time, when symptoms return between regular doses of levodopa/carbidopa. The availability of ONGENTYS underscores our commitment to delivering innovative therapies that address unmet medical needs in patients living with movement disorders."
Neurocrine Biosciences INBRACE® Support Program supports patients who are prescribed ONGENTYS along their treatment journey including information on prescription fulfillment, navigating health insurance coverage requirements and financial assistance. For more information, patients may visit www.INBRACEsupportprogram.com.
The FDA approval of ONGENTYS is supported by data from 38 clinical studies, including two multinational Phase III clinical studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson's disease patients treated with ONGENTYS. In the BIPARK-1 trial, approximately 600 patients with Parkinson's disease and motor fluctuations received one of three doses of ONGENTYS (5 mg, 25 mg or 50 mg), placebo, or 200 mg doses of the COMT inhibitor entacapone for 14 or 15 weeks. In the BIPARK-2 trial, approximately 400 patients received one of two doses of ONGENTYS (25 mg or 50 mg) or placebo for 14 or 15 weeks. Both studies included a one-year open-label extension. Data from both trials showed that ONGENTYS 50 mg significantly reduced "off" time from baseline to week 14 or 15 compared to placebo. "On" time without troublesome dyskinesia also increased from baseline to week 14 or 15 compared to placebo.
Pooled safety data from the BIPARK-1 and BIPARK-2 studies indicated that the most common adverse reactions across all patients treated with ONGENTYS (incidence at least 4% and greater than placebo) were dyskinesia, constipation, blood creatine kinase increase, hypotension/syncope, and weight decrease.
In June 2016, BIAL – Portela & CA, S.A. (BIAL) received approval from the European Commission for ONGENTYS as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. BIAL currently markets ONGENTYS in Germany, United Kingdom, Spain, Portugal and Italy. Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the United States and Canada.