Neurocrine Biosciences, Inc. announced it will present data analyses evaluating the efficacy and safety of ONGENTYS® (opicapone) capsules, recently approved by the U.S. Food and Drug Administration (FDA) as the first and only once-daily catechol-O-methyltransferase (COMT) inhibitor as an add-on to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. New data from a post-hoc, sub-group analysis of Phase III data showed that ONGENTYS led to greater reductions in overnight "off" time and time to morning "on" time compared to entacapone in patients with Parkinson's disease with motor fluctuations. In another Phase III post-hoc sub-group analysis, long-term use of ONGENTYS in patients with Parkinson's disease with motor fluctuations reduced "on" time with troublesome dyskinesia and increased good "on" time without troublesome dyskinesia. In this analysis, long-term use of ONGENTYS was associated with a reduction in the patient's average daily levodopa dosage requirement. These data will be presented in collaboration with BIAL at the American Neurological Association (ANA) 2020 Virtual Meeting on October 4–9, 2020. About Parkinson's Disease Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disorder that affects approximately one million people in the United States and six million people worldwide. Parkinson's disease is caused by low dopamine levels produced in the brain. Dopamine helps transmit signals between the areas of the brain that control all purposeful movements, including talking, walking and writing. As Parkinson's disease progresses, dopamine production steadily decreases, resulting in increased problems with motor symptoms including slowed movement (bradykinesia), tremor, rigidity, impaired posture and balance, and difficulty with speech and writing. 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: ONGENTYS is a unique, once-daily, oral, peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor approved by the U.S. Food and Drug Administration (FDA) as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. ONGENTYS inhibits the COMT enzyme, which breaks down levodopa, making more levodopa available to reach the brain. 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 U.S. and Canada. Important Information: Approved Use ONGENTYS® (opicapone) capsules is a prescription medicine used with levodopa and carbidopa in people with Parkinson's disease (PD) who are having "OFF" episodes. It is not known if ONGENTYS is safe and effective in children. Important Safety Information: Do not take ONGENTYS if you: take a type of medicine called a non-selective monoamine-oxidase (MAO) inhibitor. have a tumor that secretes hormones known as catecholamines. Before taking ONGENTYS, tell healthcare provider about all of the medical conditions, including if you: have daytime sleepiness from a sleep disorder, have unexpected periods of sleep or sleepiness, or take a medicine to help one sleep or that makes one feel sleepy. have had intense urges or unusual behaviors, including gambling, increased sex drive, binge eating, or compulsive shopping. have a history of uncontrolled sudden movements (dyskinesia). have had hallucinations or psychosis. have liver or kidney problems. are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell the healthcare provider about all the medicines one take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell the healthcare provider if one take nonselective MAO inhibitors (such as phenelzine, tranylcypromine, and isocarboxazid) or catecholamine medicines (such as isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of how one 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? Do not drive, operate machinery, or do other dangerous activities until one know how ONGENTYS affects you. What are the possible side effects of ONGENTYS? ONGENTYS may cause serious side effects, including: Falling asleep during normal activities such as driving a car, talking or eating while taking ONGENTYS or other medicines used to treat Parkinson's disease, without being drowsy or without warning. This may result in having accidents. The chances of falling asleep while taking ONGENTYS are higher if one take other medicines that cause drowsiness. Low blood pressure or dizziness, light headedness, or fainting. Uncontrolled sudden movements (dyskinesia). ONGENTYS may cause uncontrolled sudden movements or make such movements worse or happen more often. Seeing, hearing, or feeling things that are not real (hallucinations), believing things that are not real (delusions), or aggressive behavior. Unusual urges (impulse control and compulsive disorders) such as urges to gamble, increased sexual urges, strong urges to spend money, binge eating, and the inability to control these urges. Tell the healthcare provider if one experience any of these side effects or notice changes in the 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 of the possible side effects of ONGENTYS. Call the healthcare provider for medical advice about side effects.