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Date: 2018-02-14

Type of information: Submission of a Market Application in the US

Product name: Ongentys®

Compound: opicapone

Therapeutic area: Neurodegenerative diseases

Action mechanism:

  • enzyme inhibitor/COMT inhibitor. Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor that increases L-DOPA plasma levels when used concomitantly with L-DOPA/DOPA-decarboxylase inhibitors (DDCIs). Opicapone increases the bioavailability of levodopa by up to 55% vs placebo.
  • In February 2017, Neurocrine Biosciences and BIAL  have entered into an exclusive licensing agreement for the development and commercialization of opicapone in North America.

Company: Bial-Portela (Portugal) Neurocrine Biosciences (USA - CA)

Disease: adjunctive therapy in adult patients with Parkinson’s disease and motor fluctuations

Latest news:

  • • On February 14, 2018, Neurocrine Biosciences announced that the FDA has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone after receiving meeting minutes from the January 2018 meeting with the FDA. Most importantly, the Neurology Division of the FDA has not requested that Neurocrine conduct an additional Phase III study for opicapone prior to the NDA filing. As a result, Neurocrine will proceed with plans to file the NDA for opicapone during the first half of 2019.
  • • On July 5, 2016, Bial  announced that Ongentys® (opicapone) for the treatment of adult Parkinson´s disease patients with motor fluctuations was approved by the European Commission. Bial will make the drug available for Parkinson’s disease patients across Europe in 2016 and 2017. Ongentys® is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations. A large and comprehensive clinical development programme supports the European Commission approval, including 28 human pharmacology studies completed and more than 900 patients exposed to opicapone in 30 countries worldwide. The two pivotal phase III studies, BIPARK-I1 and BIPARK II2 demonstrated that ONGENTYS® once-daily achieved an absolute reduction in OFF-time of 2 hours without increasing ON-time with troublesome dyskinesia, statistically significant reductions in absolute OFF-time compared to placebo (P=0.0015) and statistically significant increases in ON-time without troublesome dyskinesia compared to placebo (P=0.002). Ongentys® (opicapone) once-daily was also associated with significant improvements in both patient and clinician global assessments of change. BIPARK-I was an active-controlled trial and included an entacapone arm: opicapone once-daily was successfully demonstrated to be at least as effective as entacapone dosed multiple times per day (non-inferiority test). The data from the phase III trials demonstrated that opicapone improves motor fluctuations in levodopa-treated patients regardless of concomitant dopamine agonist or monoamine oxidase type B inhibitors use. It has also been demonstrated to be well-tolerated in the whole trial population and in the subset of patients over 70 years, and is not associated with relevant electrocardiographic or hepatic adverse events. Both phase III trials included a 1-year open-label extension and opicapone demonstrated an OFF-time reduction from the double-blind phase baseline that was sustained over the open-label phase and was noted to have slightly improved compared to the end of the double-blind phase. In BIPARK-I, during the 1-year open-label follow-up period, patients switching from entacapone to ONGENTYS® once-daily achieved significant reductions in OFF-time (additional 39.3 min reduction) and significant increases in ON-time (additional 46 min increase). • On 28 April 2016, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Ongentys®, indicated as adjunctive therapy in adult patients with Parkinson’s disease and motor fluctuations. Ongentys® will be available as hard capsules (25 mg and 50 mg). The benefits with Ongentys® are its ability to decrease off-time (time when patients are severely restricted by their symptoms) and to increase on-time without troublesome dyskinesia. The most common side effects are dyskinesia, constipation, insomnia, dry mouth and dizziness.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2016-07-05

Favourable opinion UE: 2016-04-28

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes