As adcomm looms, ICER raises questions over Lykos’ MDMA studies

The In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view said it can­not fair­ly judge Lykos Ther­a­peu­tics’ MD­MA-as­sist­ed ther­a­py for post-trau­mat­ic stress dis­or­der be­cause of con­cerns about cer­tain el­e­ments of its clin­i­cal tri­als.

The drug pric­ing watch­dog said some tri­al par­tic­i­pants al­ready had pre­con­cep­tions about psy­che­delics and that the tri­als may not have been ef­fec­tive­ly blind­ed, which makes it dif­fi­cult to eval­u­ate the treat­ment’s risk-ben­e­fit pro­file.

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