Ongentys® (opicapone) has been made available by Neurocrine Biosciences as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease (PD) experiencing off episodes.
Opicapone is an oral, selective and reversible inhibitor of catechol-O-methyltransferase (COMT). By blocking the COMT enzyme, opicapone prevents the breakdown of levodopa, increasing its exposure and clinical effects in PD patients. The treatment is administered once daily at bedtime.
In April 2020, the Food and Drug Administration approved Ongentys based on data from 2 clinical trials, BIPARK-1 and BIPARK-2. Results from both studies showed that treatment with opicapone 50mg significantly reduced mean absolute off time and increased on time without troublesome dyskinesia compared with placebo.
With regard to safety, the most common adverse reactions reported with Ongentys include dyskinesia, constipation, increased blood creatine kinase, hypotension/syncope, and decreased weight. Other clinically significant adverse reactions may include cardiovascular effects with concomitant use of drugs metabolized by COMT, falling asleep during activities of daily living and somnolence, hallucinations and psychosis, impulse control/compulsive disorders, and withdrawal-emergent hyperpyrexia and confusion. The treatment is contraindicated with concomitant use of nonselective monoamine oxidase inhibitors and also in patients with pheochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
Ongentys is supplied in capsules containing 25mg and 50mg of opicapone in 30-count bottles. Treatment is administered at bedtime and patients should not eat food for 1 hour before and for at least 1 hour after taking Ongentys. Dosage reduction is recommended for patients with moderate hepatic impairment; treatment should be avoided in those with severe hepatic impairment.
The Company is also offering the INBRACE® Support Program to assist eligible patients.
For more information visit ongentys.com.
- Neurocrine Biosciences announces once-daily Ongentys® (opicapone) now available in the US as an add-on treatment for patients with Parkinson’s disease experiencing “off” episodes. https://www.prnewswire.com/news-releases/neurocrine-biosciences-announces-once-daily-ongentys-opicapone-now-available-in-the-us-as-an-add-on-treatment-for-patients-with-parkinsons-disease-experiencing-off-episodes-301130083.html. Accessed September 14, 2020.
- Ongentys [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2020.