FDA Approves Amneal’s Extended-Release Crexont for the Treatment of Parkinson Disease

Image Credit: Adobe Stock Images/LIGHTFIELD STUDIOS

The FDA has approved Amneal’s Crexont, an oral, extended-release formulation of carbidopa and levodopa (CD/LD) for the treatment of patients with Parkinson disease (PD). According to the company, the new treatment offers a significant improvement over existing therapies by providing longer-lasting symptom relief with fewer daily doses. The clinical trials of Crexont showed noteworthy increases in “Good On” time, which is described as time without troublesome dyskinesia as the disease progresses and represents a period without serious adverse effects (AEs).¹

“The approval of Crexont is a seminal moment in the treatment paradigm for [PD]. The burden of this incurable neurodegenerative disease increases with time. Some PD patients on [immediate release (IR)] CD/LD take up to 10 daily doses and still experience motor fluctuations. Crexont’s innovative formulation provides a longer duration of ‘Good On’ time with less frequent dosing compared to IR CD/LD. Amneal is so excited to introduce this meaningful new treatment for Parkinson’s patients in the US and soon internationally. We are committed to continuing to advance Parkinson’s research and development as a leader in the space,” said Chirag and Chintu Patel, co-CEOs, Amneal, in a press release.

Amneal stated that therapies currently on the market are short-acting, with patients possibly experiencing more motor fluctuations and less daily “Good On” time. Crexont demonstrated an improvement of 0.5 hours of additional “Good On” time per day compared to current therapies. On average, patients only need three doses of Crexont a day compared to five for the other therapies. The safety profile of Crexont was consistent with that of IR CD/LD, with common AEs being nausea and anxiety.

Amneal warns against the use of Crexont if a patient is taking nonselective monoamine oxidase inhibitors or with other CD/LD preparations without consulting a healthcare provider. Additionally, use of the drug may result in patients falling asleep during activities of daily living, somnolence, or dizziness, and patients should refrain from activities that require alertness, such as driving and operating machinery until the effects of the medication are known. Lastly, Amneal advises against sudden discontinuation or rapid dose reduction, citing the need to work with a healthcare professional to slowly lower the dose if a patient plans on discontinuing treatment.¹

“The treatment goals for people living with [PD] include achieving a more robust duration of benefit per dose of LD, reducing ‘Off’ time, and simplifying dosing regimens. 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, which is very encouraging for both patients and the Parkinson’s community,” said Robert A. Hauser, MD, professor of neurology, University of South Florida, director, Parkinson's Disease and Movement Disorders Center, in the press release.

According to the World Health Organization, the prevalence of PD has doubled over the past 25 years. In 2019, global statistics found that there were 8.5 million individuals worldwide with PD. Additionally, these statistics suggest that PD resulted in 5.8 million disability adjusted life years, up 81% from 2000, and resulted in approximately 329,000 deaths worldwide, a 100% increase from 2000.²

“People living with [PD] experience a notable decrease in quality of life over time and they experience more ‘Off’ time and other side effects. As the PD community explores treatment options that address the challenges faced by people with [PD] 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,” said Andrea Merriam, CEO, Parkinson & Movement Disorder Alliance, in the press release.

References

1. Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to Be Launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules. Amneal. August 7, 2024. Accessed August 8, 2024. https://investors.amneal.com/news/press-releases/press-release-details/2024/Amneal-Receives-U.S.-FDA-Approval-for-IPX203-for-Treatment-of-Parkinsons-Disease-to-Be-Launched-as-CREXONT-Carbidopa-and-Levodopa-Extended-Release-Capsules/default.aspx#:~:text=BRIDGEWATER%2C%20N.J.--(BUSINESS%20WIRE,of%20Parkinson's%20disease%20(PD).

2. Parkinson’s disease. WHO. August 9, 2023. Accessed August 8, 2024. https://www.who.int/news-room/fact-sheets/detail/parkinson-disease#:~:text=Assessment%20and%20disease%20burden&text=The%20prevalence%20of%20PD%20has,8.5%20million%20individuals%20with%20PD.