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Parkinson's disease is the second most common neurodegenerative disorder in
"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
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 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,
About Parkinson's Disease
Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disorder that affects approximately one million people in
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 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.
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 your healthcare provider about all of your 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 you sleep or that makes you 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 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?
- Do not drive, operate machinery, or do other dangerous activities until you 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. Your chances of falling asleep while taking ONGENTYS are higher if you 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 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
Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from ONGENTYS; the size of the potential market for ONGENTYS; the value ONGENTYS brings to patients; the timing of ONGENTYS's availability; the ability of
SOURCE
Navjot Rai (Media), 858-617-7623, media@neurocrine.com, Todd Tushla (Investors), 858-617-7143, ir@neurocrine.com