Opicapone (Ongentys) is a novel, peripherally selective and reversible catechol-O-methyltransferase (COMT) inhibitor. It was approved for marketing by the U.S. Food and Drug Administration (FDA) in 2020. By optimizing the metabolic process of levodopa in patients with Parkinson's disease, this drug provides an innovative treatment option for controlling motor symptom fluctuations.

What Are the Indications for Opicapone (Ongentys)?

Core Therapeutic Positioning

Opicapone is explicitly indicated as an adjunctive therapy to levodopa/carbidopa, specifically targeting the occurrence of "off" episodes in patients with Parkinson's disease (PD).

Its mechanism of action is based on inhibiting COMT activity. When the decarboxylation of levodopa is blocked by carbidopa, COMT becomes the main metabolic pathway of levodopa, catalyzing its conversion to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).

Dosage Forms, Specifications and Properties of Opicapone (Ongentys)

Specification Parameters

50mg capsules: Size 1, designed with a dark blue opaque cap and a dark pink opaque body. The white "OPC" logo overlaid with "50" is printed axially on both the cap and the body.

25mg capsules: Also size 1, featuring a light blue opaque cap and a light pink opaque body, with the blue "OPC" logo overlaid with "25" printed on it.

Physicochemical Properties

The chemical name of opicapone is 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide.

Its molecular formula is C₁₅H₁₀Cl₂N₄O₆, with a molecular weight of 413.17.

The active ingredient exists as a yellow powder/crystalline solid with limited solubility in water.

Formulation Composition

In addition to the active ingredient, the capsules contain the following excipients: lactose, magnesium stearate, pregelatinized starch, and sodium carboxymethyl starch.

The capsule shell is composed of FD&C Blue No.2, FD&C Red No.3, gelatin, and titanium dioxide.

Storage Methods for Opicapone (Ongentys)

Storage Conditions

The drug must be stored at a temperature below 30°C (86°F).

Ensure the original packaging is intact and avoid exposure to moisture, direct sunlight, and high temperatures.

The packaging specifications include child-resistant bottles of 30 capsules, with corresponding National Drug Code (NDC) numbers 64896-403-01 (for 50mg strength) and 64896-402-01 (for 25mg strength).

Stability Assurance

Appropriate storage conditions can ensure the chemical stability and therapeutic effect of the drug throughout its validity period.

The drug should be placed in a safe location out of the reach of children to strictly prevent accidental ingestion.