Gocovri Approved for Parkinson
August 24, 2017 – The U.S. FDA has approved Gocovri™ (amantadine) extended-release capsules, manufactured by Adamas Pharmaceuticals, for the treatment of involuntary muscle movement (dyskinesia) in patients with Parkinson’s disease who are receiving levodopa-based therapy. A standard treatment for Parkinson’s, levodopa has been known to cause levodopa-induced dyskinesia (LID) in approximately 20% of the estimated 1 million patients affected by Parkinson’s disease in the U.S., according to Adamas. The extended release formulation of Gocovri will deliver consistently high levels of amantadine throughout the day to patients. Prior to the approval of Gocovri, generically-available amantadine has been used off-label to treat LID, though patients were required to take multiple doses during the day to control dyskinesia symptoms.
Recommended dosing of Gocovri is 137mg per day at bedtime for the first week, followed by an increase to 274mg once per day for maintenance. Gocovri will be available in 68.5mg and 137mg capsules. Although Adamas plans to make the drug available in the fourth quarter of 2017, the formal product launch is not expected until January of 2018.
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.