Crexont FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 12, 2024.
FDA Approved: Yes (First approved August 7, 2024)
Brand name: Crexont
Generic name: carbidopa and levodopa
Dosage form: Extended-Release Capsules
Previous Name: IPX203
Company: Amneal Pharmaceuticals LLC
Treatment for: Parkinson's Disease
Crexont (carbidopa/levodopa) is a novel formulation of immediate and extended-release carbidopa/levodopa (CD/LD) for the treatment of Parkinson’s disease.
- Crexont is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.
- Parkinson’s disease is a progressive disorder of the central nervous system affecting dopamine-producing neurons in the brain that affect movement. It is characterized by slowness of movement, stiffness, resting tremor and impaired balance.
- Crexont contains carbidopa (an aromatic amino acid decarboxylation inhibitor) and and levodopa (an aromatic amino acid), a well established combination for the treatment of Parkinson’s disease first approved in 1975 under the brand name Sinemet.
- Crexont is a novel formulation of CD/LD containing immediate-release (IR) granules for rapid onset of action and extended-release (ER) pellets for long-lasting efficacy. The IR granules consist of carbidopa and levodopa, with a disintegrant polymer to allow for rapid dissolution. The ER pellets consist of levodopa coated with a sustained release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the pellets from disintegrating prematurely in the stomach.
- Results from the pivotal Phase 3 RISE-PD clinical trial demonstrated therapeutic benefits with Crexont including more "Good On" time with less frequent dosing, and significantly less "Off" time when compared with IR CD/LD.
- Crexont extended-release capsules are administered orally two to four times a day depending on previous treatment, the patient's clinical response, and tolerability.
- Warnings and precautions associated with Crexont include falling asleep during activities of daily living, withdrawal-emergent hyperpyrexia and confusion with sudden discontinuation or rapid dose reduction, cardiovascular events in patients with a history of cardiovascular disease, hallucinations/psychosis, impulse control disorders, and dyskinesia.
- Common adverse reactions (incidence ≥ 3% and greater than IR CD/LD) include nausea and anxiety.
Development timeline for Crexont
Further information
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