FDA staff suggests safety profile of Sage postpartum depression drug disqualifies it from at-home infusions
Ahead of Friday’s advisory committee panel on Sage Therapeutics’ $SAGE brexanolone, FDA reviewers recommended that the postpartum depression drug be administered in the presence of a healthcare professional outside the patient’s home.
The agency’s main concern with the drug formerly known as SAGE-547 was with an observed loss of consciousness during infusion, which occurred in 6 of 140 women exposed to brexanolone. After evaluating the dose, blood level, concurrent medications, available medical history, and patient characteristics, FDA reviewers found no relationship between these factors and the occurrence of LOC, making the event unpredictable.
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