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Evaluation of the Effectiveness of the Risk Minimization Measures of Sodium Oxybate in the European Union.


ABSTRACT: BACKGROUND:Sodium oxybate (Xyrem®), approved by the European Medicines Agency (EMA) for narcolepsy with cataplexy, is only available through risk mitigation programs due to potential adverse effects including respiratory and central nervous system depression, neuropsychiatric events, and misuse. OBJECTIVE:We report findings from a survey evaluating effectiveness of the European Union Xyrem® Risk Management Plan (RMP). PATIENTS AND METHODS:A cross-sectional, online, multiple-choice survey was distributed to randomly selected healthcare professionals (HCPs) from six European countries (April 2016-May 2018). Eligibility criteria: current/potential Xyrem® prescriber and/or sleep disorder specialist; contact information available; on the Xyrem® RMP educational materials mailing list. PRIMARY OUTCOME:proportion of respondents answering each question correctly (

SUBMITTER: Iranzo A 

PROVIDER: S-EPMC7581670 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Evaluation of the Effectiveness of the Risk Minimization Measures of Sodium Oxybate in the European Union.

Iranzo Alex A   Serralheiro Pedro P   Schuller Jan-Christof JC   Schlit Anne-Françoise AF   Bentz Jürgen W G JWG  

Drugs - real world outcomes 20201201 4


<h4>Background</h4>Sodium oxybate (Xyrem<sup>®</sup>), approved by the European Medicines Agency (EMA) for narcolepsy with cataplexy, is only available through risk mitigation programs due to potential adverse effects including respiratory and central nervous system depression, neuropsychiatric events, and misuse.<h4>Objective</h4>We report findings from a survey evaluating effectiveness of the European Union Xyrem<sup>®</sup> Risk Management Plan (RMP).<h4>Patients and methods</h4>A cross-secti  ...[more]

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