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Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to Be Launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules
Delivers more "Good On" time with less frequent dosing compared to Immediate Release CD/LD
Underscores Amneal’s leadership in Parkinson’s disease and commitment to one million people currently living with Parkinson’s disease in the U.S.
CREXONT commercial launch planned in September 2024
BRIDGEWATER, N.J., August 07, 2024--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) ("Amneal" or the "Company") today 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) pellets.
"The approval of CREXONT is a seminal moment in the treatment paradigm for Parkinson’s disease. The burden of this incurable neurodegenerative disease increases with time. Some PD patients on IR CD/LD take up to 10 daily doses and still experience motor fluctuations. CREXONT’s innovative formulation provides a longer duration of "Good On" time with less frequent dosing compared to IR CD/LD. Amneal is so excited to introduce this meaningful new treatment for Parkinson’s patients in the U.S. and soon internationally. We are committed to continuing to advance Parkinson’s research and development as a leader in the space," said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal.
Existing oral IR CD/LD products are short-acting, and patients can experience more motor fluctuations and less daily "Good On" time, defined as "On" time without troublesome dyskinesia, as the disease progresses. There are approximately one million people with PD living in the U.S. and approximately 90,000 new cases diagnosed each year. One 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 achieve more "Good On" time with fewer daily doses.
CREXONT’s therapeutic benefits include:
More "Good On" time with less frequent dosing: CREXONT demonstrated a statistically significant improvement of 0.5 hours of additional "Good On" time per day compared to IR CD/LD, with an average of three times a day dosing with CREXONT compared to five times a day dosing with IR CD/LD, in the RISE-PD clinical trial. A post-hoc analysis of the primary endpoint on a per dose basis showed 1.6 hours additional "Good On" time per dose of CREXONT, compared to IR CD/LD.
Novel formulation designed to provide long lasting efficacy: CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy.
Safety profile consistent with IR CD/LD: The most common adverse reactions with CREXONT (incidence ≥3% and greater than IR CD/LD) are nausea and anxiety. See Important Safety Information below.
"The treatment goals for people living with Parkinson’s disease include achieving a more robust duration of benefit per dose of LD, reducing ‘Off’ time, and simplifying dosing regimens. CREXONT’s longer ‘Good On’ time per day and per dose represents a substantial advancement in managing motor symptoms and maintaining more consistent therapeutic effects, which is very encouraging for both patients and the Parkinson’s community," said Robert A. Hauser, M.D., Professor of Neurology at the University of South Florida and Director of the Parkinson's Disease and Movement Disorders Center.
"People living with Parkinson’s disease experience a notable decrease in quality of life over time and they experience more ‘Off’ time and other side effects. As the PD community explores treatment options that address the challenges faced by people with Parkinson's disease and their families, we champion advances like CREXONT that improve ‘Good On' time, allowing people more time to do the things they love with the people they love," said Andrea Merriam, Chief Executive Officer of Parkinson & Movement Disorder Alliance.
Amneal expects to make CREXONT available to patients in the U.S. in September 2024.
About CREXONT
CREXONT is an innovative formulation consisting of IR granules with carbidopa and levodopa for rapid onset of action, and ER pellets with levodopa for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY® (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015.
INDICATION
CREXONT (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.
IMPORTANT SAFETY INFORMATION
Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.
Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.
CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery, until you know how CREXONT affects you.
The most common side effects that may occur with CREXONT are nausea and anxiety.
Avoid sudden discontinuation or rapid dose reduction with CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.
You may take CREXONT with or without food; but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.
Swallow CREXONT whole. Do not chew, divide, or crush the capsules.
Do not take CREXONT with alcohol.
Tell your healthcare provider if you:
Have any heart conditions, especially if you have had a heart attack or irregular heartbeats.
Experience hallucinations or abnormal thoughts and behaviors.
Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.
Have thoughts of suicide or have attempted suicide.
Have abnormal involuntary movements that appear or get worse during treatment.
Have ever had a peptic ulcer or glaucoma.
Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.
Are breastfeeding during therapy.
Have side effects; your doctor can adjust your dose.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals, LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or fda.gov/medwatch.
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