Generic Name: safinamide
Brand Name: Onstryv
Manufacturer: Valeo Pharma Inc.
Indications: Parkinson's disease
Manufacturer Requested Reimbursement Criteria1: Onstryv (safinamide tablets) is indicated as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD) in patients experiencing off episodes while on a stable dose of levodopa. Onstryv has not been shown to be effective as monotherapy for the treatment of PD.
Submission Type: New
Project Status: Active
Fee Schedule: Pending
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
|Call for patient input posted||April 30, 2019|
|Patient group input closed||June 19, 2019|
|Patient input summary sent for review to patient input groups||-|
|Patient group comments on input summary closed||-|
|Submission received||May 29, 2019|
|Submission accepted for review||June 12, 2019|
|Review initiated||June 18, 2019|
|Draft CADTH review report(s) sent to applicant||-|
|Comments from applicant on draft CADTH review report(s) received||-|
|CADTH review team's comments on draft CADTH review report(s) sent to applicant||-|
|Canadian Drug Expert Committee (CDEC) meeting||-|
|CDEC recommendation sent to applicant and drug plans||-|