Written By: Pharmacally Medical News Desk
Amneal Pharmaceuticals has released positive interim findings from its ongoing Phase 4 ELEVATE-PD study evaluating CREXONT®, an extended-release formulation of carbidopa and levodopa, in people with Parkinson’s disease. The new results were presented at the Parkinson’s Study Group Annual Meeting and highlight measurable improvements in key motor function outcomes after switching patients from existing levodopa-based regimens to CREXONT.
Background on Parkinson’s and CREXONT
Parkinson’s disease is a progressive neurological disorder defined by motor symptoms such as tremor, rigidity, and slowness of movement. Most patients rely on carbidopa/levodopa combinations to manage these symptoms. Standard oral therapies often leave gaps in symptom control, leading to periods of reduced mobility or “Off” time. CREXONT is designed as a next-generation extended-release capsule utilizing a mucoadhesive polymer to prolong levodopa absorption and smooth plasma levels throughout the day.
Phase 4 ELEVATE-PD Study
The ELEVATE-PD trial is an open-label, Phase 4, multi-center study assessing the real-world effectiveness and safety of switching to CREXONT in adults with moderately severe Parkinson’s disease experiencing motor complications despite stable oral levodopa regimens. Approximately 220 participants will be followed across multiple visits over 13 to 14 months.
In the first 55 patients evaluated after six weeks on CREXONT, investigators observed robust changes in daily symptom control compared with patients’ previous therapies: The results show that patients experienced longer periods during the day when their symptoms were well controlled, known as “Good On” time, and less time when symptoms returned or worsened, known as “Off” time.
Patients switching from immediate-release carbidopa/levodopa experienced an increase of +3.13 hours/day in “Good On” time, while those switching from immediate-release carbidopa/levodopa plus a COMT inhibitor gained +2.31 hours/day, and those switching from RYTARY gained +1.80 hours/day. Daily “Off” time decreased by −2.83 hours, −2.36 hours, and −2.57 hours, respectively. The duration of symptom control per dose also increased by +1.86 hours, +0.77 hours, and +0.79 hours across the same groups. These functional improvements were supported by reductions in MDS-UPDRS total scores of −14.2, −4.1, and −13.9 points, indicating meaningful improvement in motor symptoms and daily functioning following the switch to CREXONT.
Safety Profile
In this interim analysis, treatment-emergent adverse events were generally mild to moderate and consistent with expectations for levodopa-based therapies. The most frequently reported events (occurring in ≥3% of participants) were nausea (5.5%), falls (3.6%), dizziness (3.6%), and urinary tract infection (3.6%). Patients were advised that CREXONT should not be taken with nonselective monoamine oxidase inhibitors and may cause somnolence or dizziness in some individuals.
Dr. Stuart Isaacson, Director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, Florida, said the interim ELEVATE-PD results align with routine clinical experience, noting that patients treated with CREXONT tend to experience longer and more consistent “On” periods with improved day-to-day symptom control.
Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal Pharmaceuticals, stated that the interim findings highlight CREXONT’s differentiated clinical performance in real-world use, supporting observed improvements in daily function for people living with Parkinson’s disease.
These results will be supplemented with additional data as ELEVATE-PD continues, including longer-term and patient-reported outcomes expected in 2026. The improvements in “On” time and motor scores suggest that CREXONT may address gaps in symptom control seen with other oral carbidopa/levodopa therapies, representing a step forward in managing motor complications in Parkinson’s disease.
References
Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease, Amneal, 05 December 2025, https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-Positive-Interim-Phase-4-ELEVATE-PD-Results-With-CREXONT-for-Parkinsons-Disease/default.aspx