Sage post-partum depression drug looks good for approval, with limitations

Sage’s brexanolone looks like it is headed for US approval following a unanimous 18-0 advisory committee vote that it is effective in treating post-partum depression. Use of the intravenous anti-depressant, to be marketed as Zulresso, will likely be restricted to institutional settings, however, as loss of consciousness has been a major safety worry – the FDA is seeking to limit the potential for injuries to mothers and newborns if such events happen in the home. The adcom voted 17-1 that Zulresso's had a favourable risk-benefit profile provided application of FDA’s risk evaluation and mitigation strategy that would restrict use to inpatient settings. Zulresso’s application was supported by data from two phase III studies showing that patients taking it had a significantly reduced score on the HAM-D scale 60 hours after starting treatment when compared with placebo, although only one trial showed a significantly lower score 30 days after treatment began.

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