Crexont was previously rejected by the regulator in June 2023, citing insufficient safety data. However, Amneal Pharmaceuticals’ resubmission included findings from a healthy volunteer study.
Amneal Pharmaceuticals announced Wednesday that the FDA has approved its novel oral formulation of carbidopa/levodopa, now to be marketed under the brand name Crexont, for the treatment of Parkinson’s disease.
Chirag Patel and Chintu Patel, co-CEOs of Amneal, in a statement called Crexont’s approval “a seminal moment in the treatment paradigm for Parkinson’s disease.” The company expects to make the drug available in the U.S. in September 2024 and plans to introduce Crexont internationally soon, they said.
The combination of carbidopa and levodopa (CD/LD) is a well-known treatment for Parkinson’s disease (PD), first becoming commercially available in 1975. Levodopa, a precursor of the neurotransmitter dopamine, is metabolized into the neurochemical once ingested which improves movement and cognition in patients. Meanwhile, carbidopa prevents the conversion of levodopa outside the nervous system, minimizing side effects such as nausea.
However, existing oral immediate-release (IR) CD/LD products are short-acting, resulting in greater fluctuations in their effects. Patients experience greater motor variations and less time without troublesome dyskinesia, particularly as their disease progresses.
“Some PD patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations,” according to Amneal. “Crexont’s innovative formulation provides a longer duration of ‘Good On’ time with less frequent dosing compared to IR CD/LD.”
Crexont is formulated with both IR granules and extended-release pellets, allowing patients to experience longer stretches of time without suffering from troublesome dyskinesia, with an average dosing frequency of three times per day. Crexont’s formulation allows for the rapid onset of its effects and longer-lasting efficacy, according to Amneal.
The company first filed a New Drug Application for Crexont in November 2022, backing its FDA bid with data from the RISE-PD trial. The study showed that even when dosed less frequently than IR CD/LD, Crexont elicited significantly longer Good On time which RISE-PD defined as the total time without dyskinesia. However, in June 2023, the FDA rejected Crexont citing insufficient safety data, as reported by Reuters at the time.
In February 2024, Amneal resubmitted its application for Crexont and provided additional data from a healthy volunteer study of the drug.
In the PD space, Crexont’s approval follows the FDA’s rejection of Supernus Pharmaceuticals’ drug-device combo SPN-830, citing quality and master filing issues. SPN-830 is an amorphine infusion device that can continuously treat motor fluctuations in PD. In April 2024, AbbVie and NeuroDerm unveiled promising data for their respective continuous levodopa subcutaneous infusions, building toward regulatory submissions later this year.
