Opicapone

FDA approves ONGENTYS® ▼ (opicapone)

Retrieved on: 
Wednesday, April 29, 2020
FDA, Pharmaceutical, Health, Mental health, Health, Drugs, Catecholamines, Neurocrine Biosciences, Catechols, Opicapone, Bial, Carbidopa, L-DOPA, Parkinson's disease, Food and Drug Administration, Clinical trial, Opicapone 6, BIAL

BIAL announced today that the U.S Food and Drug Administration (FDA) has approved ONGENTYS (opicapone) as an add-on treatment to levodopa/carbidopa in patients with Parkinsons disease experiencing off episodes.

Key Points: 
  • BIAL announced today that the U.S Food and Drug Administration (FDA) has approved ONGENTYS (opicapone) as an add-on treatment to levodopa/carbidopa in patients with Parkinsons disease experiencing off episodes.
  • This approval is a landmark in BIALs ongoing commitment to the quality of life of Parkinsons patients and their caregivers.
  • We look forward to working with our partner in the U.S., Neurocrine Biosciences, to make this therapy available to patients.
  • The FDA approval of opicapone is supported by data from 38 clinical studies, including two multinational Phase III clinical studies (BIPARK-1 and BIPARK-2).

Neurocrine Biosciences Reports Second Quarter 2019 Financial Results

Retrieved on: 
Monday, July 29, 2019
Neurocrine Biosciences, Organic compounds, Opicapone, Neurocrine, Endocrine system

Sales, general and administrative (SG&A) expenses increased to $80.8 million for the second quarter of 2019, from $60.9 million for the same period in 2018.

Key Points: 
  • Sales, general and administrative (SG&A) expenses increased to $80.8 million for the second quarter of 2019, from $60.9 million for the same period in 2018.
  • The NDA for opicapone was submitted to the FDA during the second quarter of 2019.
  • Neurocrine Biosciences will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).
  • Headquartered in San Diego, Neurocrine Biosciences specializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems.

Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease

Retrieved on: 
Wednesday, July 10, 2019
Phenols, Aromatic compounds, Chemical compounds, Catechols, Nitrophenols, Neurocrine Biosciences, Opicapone, Catecholamines, Catechol-O-methyltransferase, Bial, Parkinson's disease, Neurocrine

With opicapone, we aim to prolong the benefits of levodopa by providing a new treatment option to patients with Parkinson's disease in the U.S.," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences.

Key Points: 
  • With opicapone, we aim to prolong the benefits of levodopa by providing a new treatment option to patients with Parkinson's disease in the U.S.," said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences.
  • We look forward to working with the FDA to bring this new treatment option to patients coping with this debilitating disorder."
  • Neurocrine Biosciences in-licensed opicapone from BIAL in 2017 and has exclusive development and commercialization rights in the U.S. and Canada.
  • Opicapone, an investigational treatment for Parkinson's disease in the U.S., is a novel, once-daily, selective catechol-O-methyltransferase (COMT) inhibitor.

Neurocrine Biosciences to Present Data on INGREZZA® (valbenazine) and Opicapone at the 2019 World Congress on Parkinson's Disease and Related Disorders

Retrieved on: 
Tuesday, June 11, 2019
Chemical compounds, Geriatrics, Parkinson's disease, Psychiatric diagnosis, RTT, Opicapone, Medicine, Medical specialties

The data will be presented at the 2019 World Congress on Parkinson's Disease and Related Disorders (IAPRD) in Montreal, June 16-19, 2019.

Key Points: 
  • The data will be presented at the 2019 World Congress on Parkinson's Disease and Related Disorders (IAPRD) in Montreal, June 16-19, 2019.
  • ET
    Poster Number: P 203, Topic: Movement Disorders, Tuesday, June 18, 2019 from 12:15 p.m.-1:15 p.m.
  • ET
    Poster Number: P 064, Topic: Parkinson's disease: Clinical science, therapeutics, surgical management, Monday, June 17, 2019 from 12:45 p.m.-1:45 p.m.
  • ET
    Once-Daily Opicapone Increases ON-Time in Patients with Parkinson's Disease: Results from Two Phase 3 Studies
    Poster Number: P 092, Topic: Parkinson's disease: Clinical science, therapeutics, surgical management, Monday, June 17, 2019 from 12:45 p.m.-1:45 p.m.

Neurocrine Biosciences Presents Phase III Data Analysis Demonstrating that Opicapone Added to Levodopa Resulted in a Significant and Sustained Increase in ON Time without Troublesome Dyskinesia in Parkinson's Disease Patients with Motor Fluctuations

Retrieved on: 
Sunday, May 5, 2019
Parkinson's disease, Neurological disorders, Chemical compounds, Organ systems, Opicapone, Management of Parkinson's disease, Dyskinesia, L-DOPA, Catechol-O-methyltransferase inhibitor, Carbidopa/levodopa/entacapone

The analysis found that treatment with opicapone 50 mg, added to levodopa, resulted in a significant and sustained increase in ON time without troublesome dyskinesia1, in Parkinson's disease patients with motor fluctuations.

Key Points: 
  • The analysis found that treatment with opicapone 50 mg, added to levodopa, resulted in a significant and sustained increase in ON time without troublesome dyskinesia1, in Parkinson's disease patients with motor fluctuations.
  • "Webelieve this data will translate intoreal-world benefits for Parkinson's disease patients on levodopa therapy who experience motor fluctuations, which can be disruptive and impact the patient's quality of life."
  • Opicapone is in development in the U.S. for adjunctive use with levodopa for the treatment of Parkinson's disease.
  • "Based on the Phase III data analysis, we believe once-daily opicapone has the potential to prolong the clinical effects of levodopa and help patients achieve symptom control so they can better cope with this debilitating disease."

Neurocrine Biosciences to Present Data on INGREZZA® (valbenazine) and Opicapone at the 2018 World Congress on Parkinson's Disease and Related Disorders

Retrieved on: 
Wednesday, August 15, 2018
Chemistry, Catechols, Nitrobenzenes, Neurocrine Biosciences, Organic chemistry, Opicapone, Neurocrine, Entacapone, Endocrine system

These results will be presented at the 2018 World Congress on Parkinson's Disease and Related Disorders (IAPRD) in Lyon, France, Aug. 19-22, 2018.

Key Points: 
  • These results will be presented at the 2018 World Congress on Parkinson's Disease and Related Disorders (IAPRD) in Lyon, France, Aug. 19-22, 2018.
  • "Neurocrine Biosciences is committed to bringing innovative and effective treatments to patients living with movement disorders," said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences.
  • Neurocrine will also present three analyses on opicapone from the Phase III BIPARK-I study highlighting the efficacy and safety of once-daily opicapone treatment in patients with Parkinson's disease, compared to placebo and entacapone.
  • Neurocrine Biosciences, a San Diego based biopharmaceutical company, is focused on developing treatments for neurological and endocrine related disorders.