FDA Approves CREXONT for Parkinson's, Enhances "Good On" Time

The U.S. Food and Drug Administration (FDA) has authorised CREXONT extended-release capsules manufactured by Amneal Pharmaceuticals to treat Parkinson's disease (PD). A new oral formulation of carbidopa/levodopa (CD/LD) called CREXONT combines ER pellets with immediate-release (IR) granules. Given that Parkinson's disease is an incurable neurodegenerative illness that is becoming more and more common, the FDA's clearance represents a significant advancement in the treatment paradigm for the condition. Even with up to ten daily doses of IR CD/LD, some PD patients still have motor irregularities. Compared to IR CD/LD, the novel formulation of CREXONT offers a longer "Good On" period with fewer frequent dosage.

Since current oral IR CD/LD medications are short-acting, patients may have a decrease in daily "Good On" time and an increase in motor fluctuations as their illness worsens. Better oral CD/LD formulations that provide more "Good On" time with fewer daily doses are needed, as there are around a million PD patients in the United States and about 90,000 new cases diagnosed annually.

The therapeutic advantages of CREXONT include longer "Good On" times between doses, a new formulation for sustained effectiveness, and a safety profile compatible with IR CD/LD. When using CREXONT, nausea and anxiety are the most frequent side responses.

Reducing "Off" time, streamlining dosage schedules, and attaining a longer duration of effect per dose of LD are among the objectives of treatment for individuals with Parkinson's disease. The longer "Good On" time per day and per dosage of CREXONT is a significant improvement in the management of motor symptoms and preservation of more stable therapeutic effects. In September 2024, Amneal plans to make CREXONT accessible to patients in the United States.