FDA approves Crexont for Parkinson’s disease

Crexont delivers longer “Good On” time with fewer daily doses

Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Crexont (carbidopa and levodopa) extended-release (ER) capsules for the treatment of Parkinson’s disease (PD). “Crexont’s longer ‘Good On’ time per day and per dose represents a substantial advancement in managing motor symptoms and maintaining more consistent therapeutic effects,” said Robert A. Hauser, Professor of Neurology at the University of South Florida, USA, and Director of the Parkinson's Disease and Movement Disorders Center.

Crexont is a novel oral formulation of carbidopa/levodopa (CD/LD) designed to address the limitations of existing immediate-release (IR) CD/LD therapies. By combining IR granules for rapid onset and ER pellets for sustained efficacy, Crexont aims to reduce motor fluctuations and increase “Good On” time – defined as “On” time without troublesome dyskinesia.

In PD, patients often require multiple daily doses of IR CD/LD, with some taking up to ten doses per day and still experiencing motor fluctuations. Crexont’s formulation allows for fewer daily doses while maintaining therapeutic benefit. In the RISE-PD clinical trial, Crexont demonstrated an average of three doses per day compared with five doses with IR CD/LD, and a statistically significant improvement of 0.5 hours of additional “Good On” time per day. A post hoc analysis showed 1.6 hours of additional “Good On” time per dose.

The most common adverse reactions reported with Crexont were nausea and anxiety, both occurring at a rate greater than 3% and more frequently than with IR CD/LD. The overall safety profile was consistent with existing CD/LD therapies.

According to Andrea Merriam, Chief Executive Officer of Parkinson & Movement Disorder Alliance, Crexont represents a meaningful advance for patients and families affected by PD. “As the PD community explores treatment options that address the challenges faced by people with Parkinson's disease and their families, we champion advances like Crexont that improve ‘Good On’ time, allowing people more time to do the things they love with the people they love.”

Amneal Pharmaceuticals expects Crexont to be available to patients in the USA starting September 2024.

What is Crexont, and what is it used for?

Crexont is an extended-release capsule formulation of carbidopa and levodopa (CD/LD), approved by the FDA for the treatment of Parkinson’s disease.

How does Crexont differ from immediate-release CD/LD?

Crexont combines IR granules and extended-release pellets, offering longer “Good On” time and less frequent dosing compared with IR CD/LD.

What were the findings from the RISE-PD clinical trial?

Crexont showed a statistically significant improvement of 0.5 hours of additional “Good On” time per day and 1.6 hours per dose compared with IR CD/LD.

What is the safety profile of Crexont?

Crexont’s safety profile is consistent with IR CD/LD. The most common adverse reactions were nausea and anxiety.

When will Crexont be available in the USA?

Amneal expects to make Crexont available to patients in the USA in September 2024.