Regulatory Decision Summary for Arlevert
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Xediton Pharmaceutical Inc. submitted a New Drug Submission (NDS) to gain approval of Arlevert, a fixed dose combination product, for treatment of vertigo. The NDS received a Notice of Non-Compliance (NON). The sponsors response to the NON was not considered adequate regarding several major objections and a Notice of Non-Compliance - Withdrawal (NON-W) letter was issued. The sponsor subsequently filed a request for reconsideration. This report concerns the recommendations of the internal reconsideration panel that was held to address unresolved issues.
Why was the decision issued?
The primary endpoint of all the pivotal trials was the Mean Vertigo Symptom (MVS) score or the Total Vertigo Symptom score. Both are composite endpoints including 6 vertigo symptoms and 6 vertigo trigger factors. The validity of the MVS was Objection #1 of the original Notice of Non-Compliance - Withdrawal (NON-W) letter. The internal reconsideration panel concluded that the sponsor had not submitted sufficient supportive information to confirm that the MVS was a valid Patient Reported Outcome which could be used in the present day regulatory environment to support authorization for the proposed indication. Without an appropriate primary endpoint definition, it is not possible to assess the efficacy of the product for the requested indications, and a benefit-risk analysis is not possible. The panel also recommended that the 2 other Major Objections be removed from the NON-W letter. Following the panel report, a revised Notice of Noncompliance - Withdrawal Letter was issued.
Decision issued
Rejected; issued a Notice of Noncompliance - Withdrawal Letter in accordance with the Food and Drug Regulations.