Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved CREXONT® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). CREXONT is a novel oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) granules. Existing oral immediate-release CD/LD products have a short duration of action and patients may experience increased motor fluctuations and less daily “good on” time, defined as “good on” time.
(i.e., walking time without bothersome dyskinesia) as the disease progresses. There are approximately one million people with PD in the United States, and approximately 90,000 new cases are diagnosed each year.
A new patient is diagnosed with Parkinson’s disease every six minutes. In the treatment of PD, there is a need for improved oral CD/LD formulations that provide longer duration of action with fewer daily doses.
Therapeutic benefits of CREXONT include: Longer onset time with less frequent dosing: In the RISE-PD clinical trial, CREXONT demonstrated a statistically significant improvement of 0.5 hours of additional “good onset” time per day compared to IR CD/LD, with an average of three doses per day with CREXONT compared to five doses per day with IR CD/LD.
A post-hoc analysis of the primary endpoint by dose showed that the “good working time” per dose of CREXONT was 1.6 hours longer than that of IR CD/LD. A new formulation designed to deliver long-lasting efficacy: CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER granules with levodopa for long-lasting efficacy.
Safety profile consistent with IR CD/LD: The most common adverse reactions with CREXONT (incidence = 3% and higher than IR CD/LD) are nausea and anxiety. CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action and ER granules with levodopa for long-lasting efficacy. The formulation and dosages of CREXONT are different from the RYTARY® extended-release capsules (carbidopa and levodopa) approved by the US FDA in 2015.
CREXONT (carbidopa and levodopa extended-release capsules) is a prescription medicine used to treat Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s-like symptoms that may result from carbon monoxide or manganese poisoning in adults. Parkinson’s disease (PD) has become the fastest growing neurological disease in the world, with approximately 1 million people diagnosed in the United States. It is a progressive disease of the central nervous system (CNS) that affects the neurons in the brain that produce dopamine and influence movement. PD is characterized by slowness of movement, rigidity, tremor at rest, and impaired balance.
Although PD is not considered a fatal disease, it is associated with significant morbidity and disability. The average age of people with PD at diagnosis is 60 years. With increasing lifespan, the number of people with PD is expected to increase significantly in the coming decades.
