CREXONT Extended-Release Capsules: New Data Demonstrate Significant Improvement in Sleep Quality in Parkinson's Disease Patients

Global biopharmaceutical companyAmneal on20244month7 released new data from its pivotal Phase 3 clinical trial of its oral carbidopa/levodopa (CD/LD) extended-release capsulesCREXONT in the treatment of Parkinson's disease. This data shows that CREXONT has significantly improved the sleep quality of patients with Parkinson's disease and achieved clinically significant effects. This study further highlights the critical role of alleviating daytime symptoms and improving sleep quality in patients to improve quality of life.

Parkinson's disease is a progressive neurodegenerative disease that seriously affects patients' motor functions and daily life. Sleep disorder is a common complication of patients. According to statistics, about 80% of Parkinson's disease patients will experience varying degrees of sleep problems. Improving these symptoms will not only improve the patient's overall quality of life but also help reduce the pain associated with morning dyskinesia. CREXONTSustained-release capsules have demonstrated significant advantages in reducing patients' nighttime symptoms and movement problems through an effective drug release mechanism.

CREXONT is an innovative oral drug that is composed of immediate-release granules (containing carbidopa and levodopa) and sustained-release granules (containing levodopa). This combination allows the drug to act quickly while providing sustained benefits. The drug received marketing approval from the US FDA in August 2024, becoming a new treatment option that can effectively relieve the symptoms of Parkinson's disease. Compared with traditional immediate-release carbidopa/levodopa formulations, CREXONT provides patients with more "Good On" time each day, and each dose of treatment helps patients control symptoms for approximately 70% longer.

In the RISE-PD clinical trial that supported CREXONT's approval, researchers analyzed 506 patients who switched to CREXONT and assessed changes in their sleep quality. The results show that using CREXONTtreated patients achieved significant improvements in Parkinson's Disease Sleep Scale2 (PDSS-2) scores, specifically demonstrating statistically significant changes in reduction of sleep disturbance, improvement in nocturnal motor symptoms, and relief of nocturnal Parkinson's disease symptoms. Specifically, CREXONT reduced patients' sleep disorder scores by 1.07, and improved nocturnal motor symptoms and nocturnal Parkinson's disease symptoms by 0.62 and 0.65, respectively. Compared with immediate-release preparations, CREXONT has a more obvious therapeutic effect, helping patients to significantly increase the proportion of patients waking up in the "on" state.

CREXONT’s clinical trials also showed that although the drug can significantly improve patients’ symptoms, it also has certain adverse reactions. Common adverse reactions include nausea and anxiety, which occur more frequently than with conventional immediate-release formulations. In addition, AmnealThe company has launched the fourth phase of clinical trial ELEVATE-PD, aiming to further evaluate the efficacy and safety of CREXONT in actual clinical settings in order to provide patients with stronger treatment support.

In summary,CREXONTSustained-release capsules, as a new type of Parkinson's disease treatment drug, can not only effectively improve patients' motor symptoms, but also significantly improve sleep quality, bringing a positive impact on patients' quality of life. As more data are released, CREXONT is expected to become one of the standard treatments for Parkinson's disease.

References:Amneal Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson’s Disease’