ONGENTYS, approved by the
"As Parkinson's disease progresses and treatment with levodopa/carbidopa begins to wear off between treatment doses, many patients begin to experience increased motor fluctuations," said Robert A. Hauser, M.D., Professor of Neurology and Director,
Data from a pooled post-hoc, sub-group analysis of Phase III studies demonstrated that ONGENTYS 50 mg significantly reduced "off" time by more than an hour compared to placebo when used as an add-on treatment in patients with Parkinson's disease treated with levodopa/carbidopa plus placebo at baseline (109.2 minutes for ONGENTYS 50 mg [n=67] vs. 40.3 minutes for placebo [n=59]; p=0.0161).
In a separate post-hoc analysis, ONGENTYS significantly increased absolute "on" time by approximately one additional hour compared with entacapone (124 minutes [n=50] vs. 60 minutes [n=47]; p=0.0344) when used as the first COMT inhibitor add-on therapy to levodopa/carbidopa in patients with Parkinson's disease recently diagnosed with motor fluctuations.
"These data analyses demonstrated the benefit of adding once-daily ONGENTYS to levodopa/carbidopa earlier in the treatment regimen of patients with Parkinson's disease. In addition to decreasing 'off' time the data also show that ONGENTYS significantly increased 'on' time compared to an older COMT inhibitor to help control motor fluctuations in patients with Parkinson's disease," said Eiry W. Roberts, MD, Chief Medical Officer,
About the BIPARK-1 Study
BIPARK-1 was a Phase III, randomized, double-blind placebo- and active-controlled study of ONGENTYS as an adjunct to levodopa therapy in which approximately 600 patients with Parkinson's disease and motor fluctuations received once-daily doses of opicapone (5 mg, 25 mg, or 50 mg), placebo, or 200 mg doses of the COMT inhibitor entacapone for 14 to 15 weeks. The primary endpoint was the change from baseline in absolute time in the "off" state, as assessed by patient diaries. The initial study period was followed by a one-year open-label phase during which all patients received treatment with opicapone.
About the BIPARK-2 Study
BIPARK-2 was a Phase III, randomized, double-blind placebo-controlled study of opicapone as an adjunct to levodopa therapy in which approximately 400 patients with Parkinson's disease and motor fluctuations received once-daily doses of opicapone (25 mg or 50 mg) or placebo for 14 to 15 weeks. The primary endpoint was the change from baseline in absolute time in the "off" state, as assessed by patient diaries. The initial study period was followed by a one-year open-label phase during which all patients received treatment with opicapone.
BIPARK-1 and BIPARK-2 were conducted by
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 associated with 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
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 of 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 is a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. For more information, visit neurocrine.com, and follow the company on LinkedIn. (*in collaboration with AbbVie)
Forward Looking Statement
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
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SOURCE
Neurocrine Biosciences: Navjot Rai (Media), 858-617-7623, media@neurocrine.com; or Todd Tushla (Investors), 858-617-7143, ir@neurocrine.com