Neurocrine Biosciences revealed plans to begin U.S. Food and Drug Administration regulatory reviews in 2019 for its Parkinson’s therapy Ongentys (opicapone).
The company confirmed its schedule post FDA meeting to file a New Drug Application for Ongentys, which European regulators approved in 2016. The application is a formal request to the FDA to begin with reviewing a treatment for possible approval.
The FDA officials decided to not include additional Phase 3 trials of Ongentys, which prompted Neurocrine to adhere to its original timetable of submitting its application in the first half of 2019.
The company developed Ongentys as a once-a-day add-on therapy to levodopa for adults suffering from Parkinson’s disease or movement disorders. The therapy inhibits an enzyme called catechol-o-methyltransferase, or COMT, that works to break down levodopa.
Ongentys prolongs the effect of levodopa by reducing the wearing off time prior to the following dose. Symptoms of patients can flare up during such off-time periods.
Scientists from BIAL, north Portuguese, developed this compound, which licensed Neurocrine with the North American rights in February 2017.
Ongentys is not associated with the generation of side effects as associated with other COMT inhibitors. EU approved the drug on successful passing of the Phase 3 trial, in July 2016. Intake of BIPARK-I (NCT01568073) and BIPARK-II (NCT01227655) revealed that a daily dose of these has the potential to decreased off-times for Parkinson’s patients.