Amneal Pharmaceuticals reports positive interim Phase 4 ELEVATE-PD results for CREXONT® in Parkinson’s disease, showing mean gains in “Good On” time, improved motor function, and manageable safety profile in real-world settings.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
Amneal Pharmaceuticals has announced positive interim findings from the ongoing Phase 4 ELEVATE-PD study (NCT06765668) evaluating CREXONT® (carbidopa and levodopa extended-release capsules) in patients with Parkinson’s disease (PD). Results presented at the Advanced Therapeutics in Movement & Related Disorders (ATRMD) 2026 Congress showed meaningful improvements in symptom control, motor function, and daily functioning among patients who switched to CREXONT from other levodopa-based therapies.
Clinical Context
Parkinson’s disease is the fastest-growing neurological disorder worldwide and affects nearly one million people in the United States. CREXONT is an extended-release formulation that uses a novel mucoadhesive polymer technology designed to optimize levodopa delivery and absorption, helping provide prolonged levodopa plasma levels and extended symptom control.
It is important to note that ELEVATE-PD is an open-label, non-randomized Phase 4 study designed to capture real-world effectiveness rather than establish causality. Interim results are descriptive, with outcomes reported as mean changes from baseline. Formal statistical testing was not emphasized in this interim analysis, and findings should be interpreted in the context of potential biases inherent to open-label designs.
Efficacy Outcomes
The six-week interim analysis included 214 patients (mean age 67.1 years) who switched from immediate-release carbidopa/levodopa (IR CD/LD; n=156), IR CD/LD plus a COMT inhibitor (n=17), or RYTARY® (n=41).
Patients switching from IR CD/LD gained a mean of 3.33 hours of daily “Good On” time, while those switching from IR CD/LD plus a COMT inhibitor and RYTARY gained 3.20 hours and 3.03 hours, respectively. Daily “Off” time was reduced by mean values of 3.20 hours, 2.96 hours, and 2.40 hours across the three groups.
Clinically meaningful improvements in motor function were also observed. MDS-UPDRS total scores improved by mean reductions of 14.6 points among patients switching from IR CD/LD, 9.9 points among those switching from IR CD/LD plus a COMT inhibitor, and 10.0 points among patients switching from RYTARY.
Among the 41 patients transitioning from RYTARY, continuous “Good On” intervals nearly doubled from a mean of 3.19 hours at baseline to 6.27 hours at Week 6. Daily motor fluctuations also decreased from a mean of 5.28 to 2.98, representing a 42.8% reduction.
Safety Profile
CREXONT was generally well tolerated. Treatment-emergent adverse events were mild to moderate and consistent with prior therapy. The most commonly reported adverse events were dizziness (8.2%), falls (6.9%), nausea (6.5%), dyskinesia (6.5%), hallucinations (3.0%), and headache (3.0%). No new safety signals were identified.
Clinical Perspective
“The results from the entire study population highlight the consistency of CREXONT in delivering meaningful benefit to patients, regardless of the therapy they had been using,” said Stuart Isaacson, MD. “This kind of reproducible, real-world signal is what gives us confidence as clinicians that patients will experience more ‘Good On’ time and fewer interruptions to their daily lives.”
Long-Term Clinical Outlook
ELEVATE-PD is an ongoing Phase 4, open-label, multicenter study that has enrolled 232 participants and is evaluating patients over a 12-month follow-up period. Longer-term outcomes, including durability of benefit, sustained motor function improvements, and extended safety monitoring, will be presented throughout 2026.
Given the open-label design and absence of randomized controls, these interim findings should be viewed as supportive evidence of real-world effectiveness rather than definitive proof of comparative superiority. The 12-month dataset will be critical in clarifying the reproducibility, durability, and safety of CREXONT in broader clinical practice.
Reference
About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.