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Government, Policy & Advocacy
Government, Policy & Advocacy
Regulation & EnforcementREMS Administrators

Avadel CNS Pharmaceuticals, LLC

Data updated

Pharmaceutical company responsible for LUMRYZ REMS implementation in the U.S., including prescriber and pharmacy certification and controlled distribution safeguards.

Regulation & Enforcement Snapshot

REMS Administrators

Authority Type

REMS Program Administrator

Jurisdiction

National

Coverage

1 country

Binding Strength

Programmatic Requirement

Function Areas

Risk Evaluation and Mitigation OversightCompliance Monitoring and InspectionsData Reporting Requirements

Framework / Program

LUMRYZ REMS Program

Policy Notes

LUMRYZ is subject to a REMS that includes certified prescriber and pharmacy workflows and restricted dispensing controls to manage serious safety and misuse risks.

Verification

Verified

Psychedelic Engagement

Psychedelic-Adjacent Focus

Framework Status

Active

Last Verified

Apr 8, 2026

Primary Policy Link

Source Evidence

FDA LUMRYZ REMS Document

https://www.accessdata.fda.gov/drugsatfda_docs/REMS/214755Orig1s000REMS.pdf

FDA Approval Letter - LUMRYZ (NDA 214755)

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214755Orig1s000ltr.pdf

LUMRYZ REMS Program

https://www.lumryzrems.com/

Quick Facts

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