Adults with Parkinson’s who switch to Crexont gain 3 hours daily on time
Real-world study also finds better motor function with extended-release drug
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- Crexont, an extended-release Parkinson's therapy, significantly increases daily on time, new real-world trial data show.
- Adults switching to Crexont from other levodopa-based treatments gained about three hours more on time and improved motor function.
- The oral therapy is approved in the U.S. for Parkinson's and under review in Canada.
People with Parkinson’s disease who switched to the approved oral therapy Crexont, an extended-release formulation of carbidopa and levodopa, from other levodopa-based treatments gained about three additional hours of daily good on time — when symptoms are well-controlled — while also experiencing less off time, or periods when symptoms aren’t fully controlled, and better motor function.
That’s according to new interim results from the real-world Phase 4 ELEVATE-PD trial (NCT06765668), which is evaluating the effectiveness and safety of switching to Crexont for adults with Parkinson’s who continue experiencing motor complications despite treatment.
The analysis focused on the study’s total population, covering 214 people with Parkinson’s previously treated with immediate-release carbidopa/levodopa therapies with or without a COMT inhibitor, or Rytary (extended-release carbidopa/levodopa capsules). The results were presented by Amneal Pharmaceuticals, Crexont’s developer, at the Advanced Therapeutics in Movement & Related Disorders (ATRMD) Congress, recently held in Washington, D.C.
“Consistent with the previously reported results, the interim data from the entire study population of ELEVATE-PD underscores [Crexont’s] ability to give patients more predictable symptoms control,” Avinash Desai, MD, Amneal’s senior vice president and chief scientific officer of specialty, said in a company press release detailing the findings.
“We believe these results further support Crexont as a differentiated extended-release oral therapy, giving patients longer continuous ‘Good On’ time per day,” Desai said.
A progressive disorder, Parkinson’s is caused by the loss of dopamine-producing nerve cells. Dopamine is a neurotransmitter, or a signaling molecule that nerve cells use to communicate with each other and the rest of the body. As dopamine levels decrease, patients experience motor symptoms, such as tremors, slowed movements, and rigidity.
Levodopa, which contains a precursor of dopamine, remains the cornerstone of Parkinson’s treatment. It is commonly given in combination with carbidopa to prevent levodopa’s conversion to dopamine before it reaches the brain.
Over time, patients may experience off episodes, or periods when disease symptoms return between treatment doses, and a decrease in periods of good on time, when symptoms are well-controlled without dyskinesia, or involuntary movements associated with the long-term use of levodopa.
Crexont designed to maintain levodopa levels longer
Crexont, approved in the U.S. in 2024, is an extended-release formulation of carbidopa and levodopa, given as capsules, that’s designed to maintain levodopa levels within a therapeutic range for a longer time. It aims to maximize good on time with less frequent dosing.
Interim findings from the ELEVATE-PD study, presented at the ATRMD Congress, showed that, among individuals previously treated with immediate-release formulations of carbidopa and levodopa, switching to Crexont increased daily good on time by 3.33 hours.
Patients transitioning from immediate-release carbidopa/levodopa therapies plus a COMT inhibitor gained 3.20 hours of good on time, while those switching from Rytary to Crexont experienced a 3.03-hour increase.
This kind of reproducible, real-world signal is what gives us confidence as clinicians that patients will experience more ‘Good On’ time and less interruptions to their daily lives [with Crexont].
“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, director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, Florida, who served as a study investigator.
“This kind of reproducible, real-world signal is what gives us confidence as clinicians that patients will experience more ‘Good On’ time and less interruptions to their daily lives,” Isaacson said.
The improvements in good on time were accompanied by reductions in daily off time. Specifically, drops of 3.20 hours were seen for patients switching from immediate-release carbidopa/levodopa therapies. Reductions in off time of 2.96 hours were found for those switching from immediate-release carbidopa/levodopa therapies plus a COMT inhibitor, and of 2.4 hours for those previously treated with Rytary.
Additionally, the total score of the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), which measures the condition’s severity and progression, decreased by 9.9 to 14.6 points when patients switched to Crexont. According to the company, reductions of this magnitude in total MDS-UPDRS scores reflect clinically meaningful gains in patients’ overall motor function.
In a subgroup analysis of 41 patients switching from Rytary, Crexont nearly doubled the duration of good on time periods, which increased from 3.19 hours before treatment to 6.27 hours after six weeks of treatment. Mean daily motor fluctuation episodes were also meaningfully reduced, from an average of 5.28 daily motor fluctuations to 2.98 at week six, corresponding to a 42.8% reduction.
Longer-term findings to be reported later in the year
Adverse events were generally mild to moderate and mainly included dizziness, affecting 8%, falls, experienced by 7%, and nausea and dyskinesia, each also affecting about 7% of participants. About 3% of patients experienced hallucinations, with the same percentage having headaches.
ELEVATE-PD is still underway, with Amneal planning to continue reporting longer-term findings from the study throughout the year, according to the company.
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