Amneal Launches CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson’s Disease
CREXONT now available in
Comprehensive access and affordability services to be made available to Parkinson’s patients and healthcare providers
Amneal to hold CREXONT launch symposium and scientific presentations at the
“We are pleased to launch CREXONT and make it broadly available to healthcare providers and patients. The product’s innovative formulation provides a longer duration of “Good On” time with less frequent dosing compared to immediate release CD/LD. As a leader in the Parkinson’s space, Amneal has a long history of working closely with movement disorder specialists and neurologists. We are excited to build on this foundation with the rollout of a comprehensive education program and extensive services to help healthcare providers and patients access this innovative therapy,” said
Information for Physicians and Patients:
- CREXONT is available only through prescription.
-
Amneal sales representatives will begin scheduling appointments with healthcare providers on
Sept. 23, 2024 . -
Samples of CREXONT will be available to healthcare providers beginning on
Sept. 23, 2024 . -
Eligible commercially insured patients may qualify for a
$25 copay on their prescriptions, applied automatically for most patients at the pharmacy through the CREXONT Savings Program. -
Eligible patients will be able to have their CREXONT prescriptions covered through the
Amneal Patient Assistance Program . -
CoverMyMeds ® is a prior authorization (PA) solution that helps patients access CREXONT by streamlining the process for healthcare providers and pharmacists. -
Amneal understands the importance of access and affordability, particularly in the context of a new product launch. To support healthcare providers, the Company’s
Field Reimbursement Specialists will be available to advise on CREXONT beginningSept. 23, 2024 .
International
Amneal will hold the following CREXONT events at this year’s
-
Dr.
Robert Hauser , CREXONT principal investigator, will present a launch symposium introducing CREXONT onFriday, Sept. 27, 2024 at1:30 pm ET entitled: Innovation in “On” time is here: introducing CREXONT® (carbidopa and levodopa) extended-release capsules. -
An abstract will be presented highlighting motor states upon awakening with CREXONT (IPX203):Abstract Title: Impact of IPX203 on Parkinson’s patients’ motor states upon awakening: analysis of patient diary data
Abstract Number: 688
Abstract Category: Parkinson’s Disease: Clinical Trials
Presentation Date and Time:Sunday, September 29 ,1:00-3:00 pm EDT
Poster Hall: Exhibit Hall A
For additional information about the
About CREXONT®
CREXONT is an innovative formulation consisting of immediate-release granules with carbidopa and levodopa for rapid onset of action, and extended-release 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
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
Please read the full Prescribing Information. For more information talk to your healthcare provider.
About Parkinson’s Disease
Parkinson’s disease (PD) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the
About Amneal
Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the
References:
- Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
- Marras et al. NPJ Parkinson’s Dis. 2018;4:21.
- NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019.
- Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
- John Hopkins Medicine. Young-Onset Parkinson’s disease.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240923995912/en/
Investor Contact
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
Senior Director, Media and Engagement, Real Chemistry
rgirard@realchemistry.com
Amneal Medical Affairs
888-990-AMRX (2679)
askamrx@amneal.com
Source: