Amneal Wins FDA Nod for CREXONT® (IPX203) Parkinson's Treatment

Amneal Pharmaceuticals, Inc. has gained approval from the U.S. FDA for CREXONT® (carbidopa and levodopa) extended-release capsules to treat Parkinson’s disease (PD). CREXONT offers a groundbreaking oral formulation that integrates immediate-release (IR) granules with extended-release (ER) pellets, providing improvements over existing treatments.

Parkinson's disease is a progressive neurodegenerative disorder marked by motor fluctuations and a need for frequent medication dosing. Traditionally, patients using IR carbidopa/levodopa (CD/LD) can take up to ten doses daily, yet still encounter motor instability. CREXONT’s new formulation aims to extend the “Good On” time—periods when motor symptoms are well controlled—while reducing the frequency of doses.

Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal, highlighted the importance of this development, stating, "The approval of CREXONT marks a transformative advance in the treatment of Parkinson’s disease. We are thrilled to introduce this significant new treatment in the United States and internationally. Our commitment to Parkinson’s research and development remains steadfast as we lead advancements in this field."

Current IR CD/LD treatments are short-acting, creating a cycle of more frequent doses and increased motor fluctuations. Approximately one million individuals in the U.S. live with Parkinson’s disease, with about 90,000 new cases diagnosed each year, making effective treatments crucial.

CREXONT provides significant therapeutic benefits, including:
1. Increased “Good On” time with less frequent dosing: Clinical trial RISE-PD demonstrated that CREXONT increased daily “Good On” time by 0.5 hours compared to IR CD/LD, with patients taking CREXONT three times a day versus five times a day for IR CD/LD.
2. Innovative formulation for sustained efficacy: CREXONT’s combination of IR granules and ER pellets ensures rapid onset of action and prolonged therapeutic effects.
3. Safety profile: The most common side effects noted with CREXONT include nausea and anxiety, similar to those observed with IR CD/LD.

Dr. Robert A. Hauser, a Professor of Neurology at the University of South Florida, stated that CREXONT’s extended duration of benefit per dose and simplified dosing regimen represent significant advancements in managing Parkinson’s motor symptoms. This is a promising development for both patients and the Parkinson’s community.

Andrea Merriam, CEO of Parkinson & Movement Disorder Alliance, emphasized the impact of such advancements, noting, "People with Parkinson’s disease experience a reduction in quality of life over time due to increased 'Off' times and other side effects. Innovations like CREXONT that improve 'Good On' time allow individuals more opportunities to engage in activities they enjoy with loved ones."

Amneal plans to make CREXONT available to U.S. patients by September 2024.

CREXONT is designed to enhance the management of Parkinson’s disease by combining IR and ER properties for better control of symptoms and reduced dosing frequency. It offers a significant improvement over the earlier approved RYTARY® (carbidopa and levodopa) extended-release capsules.

Parkinson’s disease is the fastest growing neurological disorder worldwide, affecting around one million individuals in the U.S. It disrupts dopamine-producing neurons, leading to symptoms such as slow movement, stiffness, resting tremor, and impaired balance. Although it is not considered fatal, it causes substantial morbidity and disability. The average age for Parkinson’s diagnosis is 60, and the number of cases is expected to rise as the population ages.

Amneal Pharmaceuticals, headquartered in Bridgewater, NJ, is a global pharmaceuticals company focused on developing, manufacturing, and distributing a wide range of generic and specialty pharmaceuticals primarily in the U.S. The company's expansive portfolio includes over 280 products in various therapeutic areas, including the central nervous system and endocrine disorders.

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