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Sage Therpeutics Says Primary Efficacy And Safety Endpoints Met In Phase 1/2 Trial Of SAGE-547 In Super-Refractory Status Epilepticus

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From Sage Filing:
Top-line data reported from 12 patients enrolled in the trial show that all 12 patients met the
primary endpoint, safety and tolerability. Of the 11 patients evaluable
for efficacy, eight patients met the key efficacy endpoint of being
successfully weaned off their anesthetic agents while SAGE-547 was being
administered, and eight patients were successfully weaned off SAGE-547
without recurrence of SRSE. SAGE-547 was generally well tolerated and no<
drug-related serious adverse events, as determined by the Safety Review
Committee, were reported in treated patients. SAGE is continuing to enroll patients in this trial in an expansion cohort. This expansion will include
pediatric patients as young as two years old and enable increased dosing
of SAGE-547 per a recently approved protocol amendment.

Posted-In: News FDA


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