Neurocrine Biosciences Announces Once-Daily ONGENTYS® (opicapone) Now Available in the U.S. as an Add-On Treatment for Patients with Parkinson's Disease Experiencing "Off" Episodes
SAN DIEGO, Sept. 14, 2020 /PRNewswire/ -- 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.
About Parkinson's Disease
There is presently no cure for Parkinson's disease and management of the disease consists of the use of treatments that attempt to control motor symptoms primarily through dopaminergic mechanisms. The current gold standard for treatment of motor symptoms is levodopa/carbidopa. While levodopa/carbidopa improves patients' motor symptoms, as the disease progresses, the beneficial effects of levodopa begin to wear off more quickly. Patients then experience motor fluctuations throughout the day between "on" time, periods when the medication is working and Parkinson's disease symptoms are controlled, and "off" time, when the medication is not working and motor symptoms return.
About ONGENTYS® (opicapone) Capsules
Important Safety Information
Do not take ONGENTYS if you:
Before taking ONGENTYS, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how you take the medicine (by mouth, inhaled, or by injection).
ONGENTYS and other medicines may affect each other causing side effects. ONGENTYS may affect the way other medicines work, and other medicines may affect how ONGENTYS works.
What should I avoid while taking ONGENTYS?
What are the possible side effects of ONGENTYS?
Tell your healthcare provider if you experience any of these side effects or notice changes in your behavior.
The most common side effects of ONGENTYS include uncontrolled sudden movements (dyskinesia), constipation, increase in an enzyme called blood creatine kinase, low blood pressure, and weight loss.
These are not all the possible side effects of ONGENTYS. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see ONGENTYS full Product Information.
About Neurocrine Biosciences
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SOURCE Neurocrine Biosciences, Inc.
Company Codes: NASDAQ-NMS:NBIX