Opicapone (Ongentys) is an oral capsule preparation, which was first approved for marketing in the United States in 2020. As a selective and reversible peripheral catechol-O-methyltransferase (COMT) inhibitor, it is mainly indicated as an adjunctive therapy for Parkinson’s disease.

What are the indications for Opicapone (Ongentys)?

Indications

Opicapone is indicated as an adjunct to levodopa/carbidopa for the treatment of patients with Parkinson’s disease (PD) who are experiencing motor fluctuations (OFF episodes).

Pharmacological Action

By inhibiting the COMT enzyme, opicapone reduces the metabolism of levodopa in the body (conversion to 3-O-methyldopa, 3-OMD), thereby increasing the bioavailability and duration of action of levodopa. This helps stabilize plasma drug concentrations, prolong ON time and reduce motor symptom fluctuations.

Dosage Form, Strength and Description of Opicapone (Ongentys)

50 mg Capsule

Appearance: Deep blue opaque cap and deep pink opaque body.

Marking: Axially printed with white "OPC" over "50" on both the cap and the body.

Packaging: Typically supplied as 30 capsules per bottle, fitted with a child-resistant closure.

25 mg Capsule

Appearance: Light blue opaque cap and light pink opaque body.

Marking: Axially printed with blue "OPC" over "25" on both the cap and the body.

Packaging: Typically supplied as 30 capsules per bottle, fitted with a child-resistant closure.

Composition

Active Ingredient: Opicapone.

Inactive Ingredients: Lactose, magnesium stearate, pregelatinized starch, sodium starch glycolate.

Capsule Shell Ingredients: FD&C Blue No. 2, FD&C Red No. 3, gelatin, titanium dioxide.

Pharmacokinetic Properties

Following oral administration, opicapone reaches peak plasma concentration at approximately 2 hours, has a high protein binding rate (>99%), and an elimination half-life of approximately 1–2 hours.

It is mainly metabolized via sulfonation and excreted through feces (major route), exhaled air and urine.

Storage and Handling of Opicapone (Ongentys)

Storage Temperature

Store below 30°C (86°F).

Protect from excessive heat, moisture and direct sunlight.

Safe Storage

Keep the medication out of the reach and sight of children to prevent accidental ingestion.

Storage in Original Container

It is recommended to always store the drug in its original child-resistant bottle to maintain stability and facilitate identification.

Additional Precautions

Do not store the medication in humid areas such as bathrooms or beside kitchen sinks.

Expired or unused medications should be disposed of properly in accordance with local regulations, and should not be discarded arbitrarily.