[Expert Solution]: Why was a REMS required for hickelyne

Why was a REMS required for hickelyne? – Follow-up studies revealed no association between hickelyne and neuropsychiatric events. – Concerns arose about the drug’s efficacy. – Post-approval monitoring of the drug revealed a high risk for adverse effects including mood and behavior changes. – REMS are required for all prescription drugs approved by the FDA. – Results of a randomized trial had not yet been fully evaluated.