What is the Phase 4 ELEVATE-PD trial from Amneal Pharmaceuticals (NASDAQ:AMRX)?

The ELEVATE-PD trial is a Phase 4 study evaluating the efficacy and safety of CREXONT (carbidopa and levodopa extended-release capsules) in Parkinson’s disease patients, focusing on improvements in motor symptom control and daily functioning.

How many patients were involved in the interim analysis of CREXONT?

The interim data involved 214 patients who transitioned to CREXONT for a six-week period, assessing changes in "Good On" and "Off" time and motor function scores.

What improvements did patients see in “Good On” and “Off” time?

Patients reported 3 to 3.3 extra hours of “Good On” time per day, when symptoms are controlled, and a reduction of up to 3.2 hours in daily “Off” time, during which Parkinson’s symptoms return.

How did CREXONT perform for patients previously on RYTARY?

In patients switching from RYTARY, continuous “Good On” time nearly doubled to 6.27 hours, and daily motor fluctuations decreased by 42.8%, showing significant benefit for this subgroup.

Were there any safety concerns reported with CREXONT?

Reported adverse events were consistent with the known carbidopa and levodopa profile, with most classified as mild to moderate, indicating no new safety signals in the interim analysis.

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Amneal reports positive Phase 4 data for CREXONT in Parkinson’s treatment

Written by Mahathir BayenaPublished Jun. 5 2026Last Updated Jun. 5 2026

Amneal Pharmaceuticals (NASDAQ:AMRX) has announced encouraging interim data from the Phase 4 ELEVATE-PD clinical trial, which evaluates the efficacy and safety of CREXONT (carbidopa and levodopa) extended-release capsules in patients living with Parkinson’s disease.

The results highlight substantial improvements in motor symptom management and daily functioning.

The interim analysis involved 214 patients who transitioned to CREXONT for a six-week duration.

Across various prior Parkinson’s treatment regimens, participants reported gaining approximately 3 to 3.3 hours of additional “Good On” time—the periods during which Parkinson’s symptoms are effectively controlled—per day.

Correspondingly, patients experienced a reduction in daily "Off" time, characterized by the return of symptoms, by up to 3.2 hours.

Furthermore, participants demonstrated improvements in motor scores as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

The data also highlighted specific outcomes for patients transitioning from RYTARY, another of Amneal’s therapies.

In this subgroup, continuous “Good On” time nearly doubled, increasing to 6.27 hours, while daily motor fluctuations were reduced by 42.8%.

Regarding safety, reported adverse events remained consistent with the established profile for carbidopa and levodopa, with the majority categorized as mild to moderate.

These findings follow a recent regulatory development for the drug.

In May 2026, the U.S. Food and Drug Administration (FDA) approved a label update for CREXONT, allowing the capsule contents to be sprinkled on applesauce.

This administration option is designed to assist patients who may have difficulty swallowing capsules, potentially improving treatment adherence.