SAGE-547 Designated Orphan Drug for Status Epilepticus

SAGE Therapeutics announced that the FDA has granted Orphan Drug designation to SAGE-547 for the treatment of super-refractory status epilepticus (SRSE).

SAGE-547 is an intravenous, allosteric modulator of both synaptic and extra-synaptic GABAA receptors. Numerous drugs targeting GABAA receptors in the CNS have been developed with over decades of research for a variety of CNS disorders. SAGE-547 will be studied as an adjunctive therapy for the treatment of SRSE in an upcoming Phase 1/2 clinical trial.

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Status epilepticus (SE) is a life-threatening seizure condition that is initially treated with benzodiazepines. Non-responders to benzodiazepines or second-line anticonvulsants are diagnosed with having refractory SE; these patients require ICU admission and induction into a medically induced coma. If seizure activity continues after anesthetic administration during the coma, the patient is considered to have SRSE, a condition without any approved therapies.

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