Neurocrine Biosciences will ask the U.S. Food and Drug Administration in early 2019 to begin the regulatory review process that could lead to the approval of its Parkinson’s therapy Ongentys (opicapone).
It confirmed the timetable after meeting with FDA officials on its plan to file a New Drug Application for Ongentys, which European regulators approved in 2016. The application is a formal request that the FDA start reviewing a treatment for possible approval.
FDA officials’ decision not to ask for additional Phase 3 trials of Ongentys prompted Neurocrine to stick with its original timetable of submitting the application in the first half of 2019.
Neurocrine developed Ongentys as a once-a-day add-on therapy to levodopa for adults with Parkinson’s or movement problems. It inhibits an enzyme called catechol-o-methyltransferase, or COMT, that breaks down levodopa.
Ongentys prolongs levodopa’s effect by reducing the time when it wears off before the next dose. During these off-time periods, patients’ symptoms can flare up.
Scientists at BIAL in northern Portugal developed the compound. BIAL licensed the North American rights to Neurocrine in February 2017.
Ongentys does not generate the side effects associated with other COMT inhibitors, its developers say.
In addition to Ongentys, two other COMT inhibitors are available to Parkinson’s patients: Tasmar (tolcapone), which has been linked to liver toxicity, and Comtan (entacapone). While Comtan has not been linked to toxicity, meta-analyses have shown it to be only moderately effective.
The results of two Phase 3 trials of opicapone led to the European Union approving it in July 2016. BIPARK-I (NCT01568073) and BIPARK-II (NCT01227655) showed that a daily dose decreased Parkinson’s patients’ off-times.
The 600-patient BIPARK-I trial compared opicapone with entacapone. The two generated comparable results, the research team said.
Researchers randomized the 427 patients in the BIPARK-II trial to receive either 25 mg or 50 mg a day of Ongentys or a placebo. Patients who took the higher dose of Ongentys saw their off-time drop by 119 minutes — almost twice the 65 minutes seen in the placebo group.
Ongentys improved levodopa-treated patients’ movement fluctuations regardless of whether they were also taking a dopamine agonist or a monoamine oxidase type B inhibitor, researchers said.
Patients tolerated opicapone well in both trials, the team said.
One-year extension studies of the trials showed that opicapone maintained the reduced off-times and increased on-times long term, researchers said.
“We have a tremendous amount of work ahead of us as we compile the FDA-required datasets to prepare for the NDA [New Drug Application] filing,” Dr. Eiry W. Roberts, Neurocrine’s chief medical officer, said in a press release. “As part of our commitment to helping patients with movement disorders, we are eager to continue advancing this important medicine for the nearly one million patients suffering from Parkinson’s disease in the United States.”
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