In a clinical trial, IPX203 was able to achieve longer good on-time with less doses compared to standard treatment.
Amneal Pharmaceuticals announced that the FDA has approved its extended-release carbidopa and levodopa (CD/LD, [IPX203]) capsules, marketed as Crexont, for the treatment of Parkinson’s disease, according to a company news release.1
Caregiver holding hand of older adult with Parkinson's disease / Khunatorn - stock.adobe.com
As Parkinson’s disease progresses, patients often experience increased motor fluctuations and reduced “good on-time,” defined as periods without troublesome dyskinesia.1 Whereas existing immediate-release CD/LD products are short-acting, Amneal’s IPX203 combines immediate-release granules and extended-release pellets to provide rapid onset of action and long-lasting efficacy, respectively.
About RISE-PD
Trial Name: A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
Clinicaltrials.gov Identifier: NCT03670953
Sponsor: Impax Laboratories, LLC
Summary: To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.
“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 CD/LD take up to 10 daily doses and still experience motor fluctuations,” said Chirag and Chintu Patel, co-chief executive officers of Amneal Pharmaceuticals, in the release.1 “Crexont’s innovative formulation provides a longer duration of good on-time with less frequent dosing compared to immediate-release 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 advance Parkinson’s research and development as a leader in the space,” they continued.
READ MORE: GLP-1 Shows Protection Against Dementia in Phase 2b Trial
The approval was supported by data from the 20-week, randomized, double-blind, double-dummy, active-controlled phase 3 RISE-PD (NCT03670953) clinical trial, with results published in JAMA Neurology.2 In total, 506 participants were randomly assigned to receive either IPX203 or immediate-release CD/LD. The primary end point was mean change in daily good on-time.
Compared to immediate-release CD/LD, IPX203 significantly increased daily good on-time by an average of 0.5 hours (95% CI, 0.09-0.97; P= .02), despite being administered less frequently; IPX203 was administered 3 times daily, while immediate-release CD/LD was administered 5 times daily. Additionally, a post-hoc analysis found that each dose of IPX203 provided an extra 1.6 hours of good on-time compared to immediate-release CD/LD (95% CI, 1.37-1.73; P< .001).
The most common adverse reactions associated with IPX203 were nausea and anxiety.
Amneal is set to introduce IPX203 to the market in September 2024.
“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 dose 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 at the University of South Florida and director of the Parkinson’s Disease and Movement Disorders Center, in the release.1
PD is rapidly emerging as the world’s most prevalent neurological disorder, surpassing Alzheimer’s disease in growth rate.3 In the United States alone, approximately 1 million individuals currently live with PD, with a new diagnosis occurring every 6 minutes.1 The launch of IPX203 from Amneal addresses the critical unmet need for improved oral CD/LD formulations that extend periods of symptom control and reduce dosing frequency.
“People living with Parkinson’s disease experience a notable decrease in quality of life over time and they experience more ‘off’ time and other side effects,” concluded Andrea Merriam, chief executive officer of Parkinson & Movement Disorder Alliance, in the release.1 “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.”
READ MORE: Neurology Resource Center
