Amneal Announces U.S. FDA Filing Acceptance of New Drug Application for IPX203 for the Treatment of Parkinson’s Disease
Amneal Pharmaceuticals has announced the FDA's acceptance of the New Drug Application for IPX203, a novel oral formulation aimed at treating Parkinson's disease. This extended-release treatment promises longer symptom control with fewer doses compared to immediate-release formulations. The FDA has set a PDUFA date of June 30, 2023 for review. The RISE-PD trial demonstrated that IPX203 provides significantly more 'Good On' time and less 'Off' time while being less frequently dosed. The trial included 506 patients across several countries, further supporting product efficacy.
- FDA acceptance of NDA for IPX203 for Parkinson's treatment.
- IPX203 shows significant improvements in 'Good On' and 'Off' time, enhancing patient quality of life.
- RISE-PD study involved 506 patients, showcasing robust clinical data.
- Most common adverse reaction reported was nausea in 4.3% of patients.
- IPX203 could offer people living with Parkinson’s disease a longer duration of symptom control with less frequent dosing compared to IR CD/LD treatment
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of
“The FDA filing acceptance of IPX203 marks another important milestone for Amneal as we strive to improve the lives and care of people living with Parkinson’s disease,” said Gustavo Pesquin, Chief Commercial Officer, Amneal Specialty. “We look forward to engaging in conversations with the FDA as we advance the application. We believe the data in our RISE-PD study supports the important benefit IPX203 can offer to this community by providing longer duration of symptom control with the benefit of fewer doses.”
CD/LD has been the leading treatment for PD since the 1970s. Data from the pivotal Phase 3 RISE-PD clinical trial found that IPX203’s extended-release formulation offers significantly more “Good On” time, as well as significantly less “Off” time, compared to immediate-release CD/LD, even when dosed less frequently.
“Amneal aims to provide people living with Parkinson’s disease effective treatments that allow them to live their lives with less concern about their mobility and symptoms, and more freedom to choose how to spend their time,” said Pesquin. “We are pleased that IPX203 has the potential to address this need by extending periods when symptoms are better controlled, with less frequent dosing.”
The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of
About the RISE-PD Trial
The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX203 CD/LD extended-release capsules compared with immediate-release CD/LD in the treatment of people living with PD who have motor fluctuations.
The trial consisted of a 3-week, open-label immediate-release CD/LD dose adjustment period and a 4-week, open-label period for conversion to IPX203. This was followed by a 13-week double-blind treatment period in which patients were randomized 1:1 to receive either IPX203 (with matching immediate-release CD/LD placebo) or immediate-release CD/LD (with matching IPX203 placebo). The baseline for all endpoints was Week 7 (Visit 4), which occurred pre-randomization. The most common adverse reaction (incidence ≥
The primary endpoint of the trial assessed the change from baseline in “Good On” time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). “Good On” time is defined as the sum of “On” time without dyskinesia and “On” time with non-troublesome dyskinesia. Secondary endpoints assessed the change from baseline in “Off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the
The trial was conducted at 105 clinical sites in the
About IPX203
IPX203 is a novel, oral formulation of CD/LD extended-release capsules designed for the treatment of Parkinson’s disease. IPX203 contains immediate-release granules and extended-release beads. The IR granules consist of CD and LD, with a disintegrant polymer to allow for rapid dissolution. The ER beads consist of LD, coated with a sustained release polymer to allow for slow release of the drug, a mucoadhesive polymer to keep the granules adhered to the area of absorption longer, and an enteric coating to prevent the granules from disintegrating prematurely in the stomach. This formulation is distinct from RYTARY® (carbidopa/levodopa) extended-release capsules, Amneal’s extended-release CD/LD treatment for PD approved by the
About Parkinson’s Disease
Parkinson’s disease (PD) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the
PD is characterized by slowness of movement, stiffness, resting tremor and impaired balance.3 While PD is not considered a fatal disease, it is associated with significant morbidity and disability.4 The average age at diagnosis for people with PD is 60; as people live longer, the number of people living with PD is predicted to grow significantly over the coming decades.1,5
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References:
- Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
- Marras et al. NPJ Parkinsons Dis. 2018;4:21.
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NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019. Accessed
April 16, 2021 . - Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
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John Hopkins Medicine. Young-Onset Parkinson’s disease. Accessed
August 17, 2021 .
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