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FDA Approves Amneal's CREXONT for Parkinson's Disease

Convenient Oral Formulation for Improved Symptom Control

Introduction

The US Food and Drug Administration (FDA) has granted approval to Amneal Pharmaceuticals for its extended-release carbidopa and levodopa formulation, CREXONT. This new medication offers improved efficacy and convenience for patients with Parkinson's disease compared to existing treatment options.

Dosage and Formulation

CREXONT's unique formulation and dosage strengths differentiate it from other carbidopa and levodopa products like RYTARY. It combines immediate-release (IR) carbidopa granules with extended-release (ER) carbidopa and levodopa in a single capsule. This innovative design provides both immediate and sustained symptom relief.

Clinical Trial Results

The approval of CREXONT was based on positive results from a clinical trial known as RISE-PD IPX203. The study demonstrated that CREXONT significantly improved "good on" time by 0.53 hours (95% CI: 0.09-0.97, p=0.002) compared to RYTARY. "Good on" time refers to the period during which patients experience satisfactory symptom control.

Improved Patient Outcomes

CREXONT's innovative formulation offers several benefits for patients with Parkinson's disease. Its extended-release design provides longer-lasting symptom control, reducing the number of daily doses required. The IR carbidopa granules provide faster symptom relief, allowing patients to experience symptom improvement more quickly.

Conclusion

The FDA's approval of CREXONT represents a significant advancement in the treatment of Parkinson's disease. This innovative medication offers improved efficacy, enhanced convenience, and reduced pill burden, providing hope for patients seeking effective symptom management.

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