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COMT inhibitor to be used as an adjunctive treatment to levodopa/carbidopa.
The FDA has accepted a new drug application for opicapone (Ogentys, Bial and Neurocrine Biosciences) for adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease who are experiencing off episodes. The FDA has set a 12-month review process, expected to be completed by April 2020.
Opicapone is a once-daily oral selective catechol-O-methyltransferase (COMT) inhibitor. The drug gained European approval under Bial, which markets to Germany, the United Kingdom, Spain, Portugal, and Italy. Neurocrine Biosciences in-licensed the drug from Bial in 2017, gaining exclusive development and commercialization rights in the United States and Canada.
The FDA’s approval is based on data from 38 clinical trials, including two phase 3 studies (BIPARK-1 and BIPARK-2) that included 1,000 Parkinson’s disease patients with motor fluctuations. BIPARK-1 was a randomized double-blind placebo- and active-controlled study of 600 patients who received either once-daily opicapone (5 mg, 25 mg, or 50 mg) or COMT inhibitor entacapone (200 mg) for 14 to 15 weeks. BIPARK-2 examined 400 patients who received either once-daily opicapone (25 mg or 50 mg) or placebo for 14 to 15 weeks. The primary endpoint for both studies was the change from baseline in absolute time in the OFF state, as assessed by patient diaries.
The recommended starting dose for Opicapone is 50 mg, though prescribing information suggests that adjustments will likely be necessary within the first days and weeks after administration as levodopa effects are enhanced. If a dose is missed, the next should be taken as scheduled; doses should not be doubled to account for those missed.
Contraindications for opicapone include hypersensitivity to the active substance or any of its excipients; pheochromocytoma, paraganglioma, or other catecholamine-secreting neoplasms; patients with a history of neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis; and patients currently taking monoamine oxidase (MAO-A and MAO-B) inhibitors (eg, phenelzine, tranylcypromine, and moclobemide) other than those for the treatment of Parkinson’s disease.
Prescribing information warns of dyskinesia, hallucinations, nausea, vomiting, and orthostatic hypotension that may arise as a result of opicapone’s combination with levodopa.
Other adverse events reported with the use of opicapone include nervous system disorders, specifically dyskinesia.