Extended-release Parkinson’s therapy Crexont available in US
Levodopa-carbidopa formulation designed to extend on-time periods
Crexont, an extended-release formulation of levodopa and carbidopa, is now available in pharmacies across the U.S. for people with Parkinson’s disease. The Parkinson’s therapy, marketed by Amneal Pharmaceuticals is designed to maintain steady levels of levodopa and carbidopa in the body, extending periods of optimal symptom management, known as good on time, with fewer daily doses.
“We are pleased to launch Crexont and make it broadly available to healthcare providers and patients,” Joe Renda, Amneal’s senior vice president and specialty chief commercial officer, said in a company press release. The treatment was approved by the U.S. Food and Drug Administration in August.
Crexont is available through medical prescriptions. Eligible patients may apply to the company’s patient assistance program to receive free medication for up to one year, and commercially insured patients may qualify for a $25 copay on their prescriptions, applied automatically at pharmacies through the Crexont Savings Program.
Amneal has also arranged a program through CoverMyMeds, a system designed to make it easier for healthcare providers and pharmacists to help patients gain access to treatments by simplifying the prior-approval process.
“We are excited to build on this foundation with the rollout of a comprehensive education program and extensive services to help healthcare providers and patients access this innovative therapy,” Renda said.
Parkinson’s therapy mainstay
Parkinson’s is caused by the progressive dysfunction and death of dopaminergic neurons, the nerve cells responsible for making dopamine, a crucial chemical signaling molecule involved in motor control. The loss of dopamine signaling leads to most disease symptoms.
Levodopa, a mainstay of Parkinson’s treatment, is a precursor of dopamine and is commonly given in combination with carbidopa. This prevents levodopa from being converted into dopamine before it reaches the brain. However, the therapy’s long-term use often leads to off episodes, periods when disease symptoms are not fully controlled between scheduled doses, and dyskinesia, or uncontrolled, involuntary movements.
Crexont is an extended-release, oral formulation of carbidopa/levodopa designed to maintain consistent levels of the medication in the body and improve its absorption. It contains both immediate-release and extended-release components, ensuring an initial quick release of carbidopa and levodopa, followed by a sustained release over time.
The therapy’s approval was based on data from the Phase 3 RISE-PD trial (NCT03670953), which compared the safety and efficacy of Crexont with an immediate-release formulation of levodopa/carbidopa in people with Parkinson’s, showing the treatment increased good on time by 1.5 hours per dose.
The company is planning a Crexont launch symposium and scientific presentations for the International Congress of Parkinson’s Disease and Movement Disorders, being held Sept. 27–Oct. 1 in Philadelphia.
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