Xadago Approved for Parkinson
March 21, 2017 – The U.S. FDA approved Xadago® (safinamide), manufactured by Newron Pharmaceuticals, as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking. Treatment with Xadago should be started at 50mg per day. This daily dose may be increased to 100mg per day, if needed. Xadago blocks the activity of monoamine oxidase-B (MAO-B), an enzyme that breaks down dopamine. Low dopamine levels may lead to problems with balance, movement, muscle control and other symptoms of Parkinson’s disease. Due to its high selectivity of Xadago to the MAO-B enzyme, it does not have any dietary restrictions.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.