ONGENTYS

Opicapone demonstrates dose-proportional pharmacokinetics over a 25 mg (0.5 times the recommended dosage) to 50 mg dose range. The pharmacokinetics of opicapone are similar in both PD patients and healthy subjects.

AbsorptionAfter single-dose administration of ONGENTYS 50 mg, the median (range) plasma T max value was 2.0 (1.0-4.0) hours. Effect of Food Following a moderate fat/moderate calorie meal, the mean peak plasma concentration (C max ) for opicapone decreased 62%, the mean overall plasma...

The efficacy of ONGENTYS for the adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes was evaluated in two double-blind, randomized, parallel-group, placebo- and active-controlled (

Study 1NCT01568073), or placebo-controlled (

Study 2NCT01227655) studies of 14-15 week duration. All patients were treated with levodopa/ DOPA decarboxylase inhibitor (DDCI) (alone or in combination with other PD medications). The double-blind period for each study began with a period for levodopa/DDCI dose adjustment (up to 3 weeks), followed by a stabl...

The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT) [see Warnings and Precautions ( 5.1 )] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.2 )] Hypotension/Syncope [see Warnings and Precautions ( 5.3 )] Dyskinesia [see Warnings and Precautions ( 5.4 )] Hallucinations and Psychos...

ONGENTYS is contraindicated in patients with: Concomitant use of non-selective monoamine oxidase (MAO) inhibitors [see Drug Interactions ( 7.1 ) ] . Pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. Concomitant use of non-selective monoamine oxidase (MAO) inhibitors. ( 4 ) History of pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms. ( 4 )

Cardiovascular Effects with Concomitant Use of Drugs Metabolized by Catechol-O-Methyltransferase (COMT): May cause arrhythmias, increased heart rate, and excessive changes in blood pressure. Monitor patients when treated concomitantly with products metabolized by COMT. ( 4 , 5.1 ) Falling Asleep During Activities of Daily Living: Advise patients prior to treatment. ( 5.2 ) Hypotension/Syncope: If occurs, consider discontinuing ONGENTYS or adjusting dosage of other medications that can lower bloo...

7 DRUG INTERACTIONS 7.1 Non-Selective Monoamine Oxidase (MAO) Inhibitors Both ONGENTYS and non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) inhibit catecholamine metabolism, leading to increased levels of catecholamines. Concomitant use may increase the risk of possible arrhythmias, increased heart rate, and excessive changes in blood pressure. Concomitant use of...