Eton Pharmaceuticals Announces Commercial Availability of Betaine Anhydrous for Oral Solution, a Generic Version of Cystadane® (betaine anhydrous for oral solution)
May 10 2023 - 6:50AM
Eton Pharmaceuticals, Inc (Nasdaq: ETON), an innovative
pharmaceutical company focused on developing and commercializing
treatments for rare diseases, today announced the commercial
availability of Betaine Anhydrous for Oral Solution 180 grams for
the treatment of homocystinuria.
“We are excited to be offering a lower cost alternative1 to
Cystadane while still providing full patient and provider
support services. We believe the adoption of our product will
result in significant financial savings to the U.S. healthcare
system and to many patients,” said Sean Brynjelsen, CEO of Eton
Pharmaceuticals.
Betaine Anhydrous is available exclusively through Optime Care,
a specialty pharmacy dedicated to helping patients with rare
diseases manage their conditions. Optime Care will administer the
Eton Cares Program in partnership with Eton Pharmaceuticals.
The program will provide prescription fulfillment, insurance
benefits investigation, educational support, and qualified patients
financial assistance along with other services designed to help
eligible patients access treatment. Eton Cares will offer co-pay
assistance to allow for $0 co-pays for qualifying patients.*
Clinicians seeking to prescribe Betaine Anhydrous can
e-prescribe by selecting Optime Care as the pharmacy or fax in a
patient referral form to 866-318-2990. Additional product details
can be found on the product website, www.betaineus.com.
For questions regarding prescription fulfillment, please contact
Optime Care at 1-888-673-0039.
1 https://www.analysource.com/products/active/ accessed
March 2023*Restrictions, limitations, and/or eligibility
requirements may apply
Cystadane is a registered trademark of Recordati Orphan Drugs
SAS
IMPORTANT SAFETY INFORMATION
Warnings and PrecautionsHypermethioninemia in
Patients with CBS Deficiency: Betaine Anhydrous may worsen high
methionine blood levels and accumulation of excess fluid in the
brain has been reported. If you have been told you have CBS
deficiency, your doctor will be monitoring your methionine blood
levels to see if changes in your diet and dosage are necessary.
Adverse ReactionsMost common side effects were
nausea and gastrointestinal distress, based on a survey of doctors.
To report a suspected adverse event related to Betaine Anhydrous,
contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S.
Food and Drug Administration (FDA) at http://www.fda.gov/MedWatch
or call 1-800-FDA-1088.
INDICATIONS AND USAGE
Betaine anhydrous for oral solution is indicated in children and
adults for the treatment of homocystinuria to decrease high
homocysteine blood levels. Homocystinuria is a rare genetic
disorder in which there is an abnormal accumulation of the amino
acid homocysteine in the blood and urine. The following are
considered to be homocystinuria disorders:
- Cystathionine beta-synthase (CBS) deficiency
- 5,10-methylenetetrahydrofolate reductase (MTHFR)
deficiency
- Cobalamin cofactor metabolism (cbl) defect
Please see full
Prescribing Information for more
information.
About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical
company focused on developing and commercializing treatments for
rare diseases. The Company currently has three FDA approved
products in ALKINDI SPRINKLE®, Carglumic Acid tablets for oral
suspension 200mg, and Betaine Anhydrous, and four late-stage
pipeline candidates under development with dehydrated alcohol
injection, ZENEO® hydrocortisone autoinjector, ET-400, and ET-600.
In addition, the Company receives royalties on three FDA-approved
products and is entitled to receive milestone payments on other
products. For more information, please visit our website at
www.etonpharma.com.
Investor Relations:Lisa M. Wilson, In-Site
Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com
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