Seelos Therapeutics Says Received Minutes From End Of Phase II Meeting With FDA
(RTTNews) - Biopharmaceutical company Seelos Therapeutics, Inc. (SEEL) announced Monday the receipt of minutes from its End of Phase II Meeting with the U.S. Food and Drug Administration or FDA that highlights the modifications to the primary and secondary endpoints of its Phase II Study of SLS-002.
In the meeting minutes, the FDA agreed that the primary endpoint in a Phase III trial could be the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 16, rather than the 24-hour timepoint that was selected in the Phase II SLS-002-201 study. The key secondary endpoint could be the change from baseline at 24 hours on the suicidality scale.
This agreement with the FDA gives Seelos further confidence for its Phase III development of SLS-002 as data in the Phase II study showed clinically significant treatment differences from placebo on both the Day 16 MADRS and the 24-hour Sheehan- Suicidality Tracking Scale.
The company plans to continue its previously announced potential partnership discussions and expects to proceed to Phase III with SLS-002 in adults with Major Depressive Disorder (MDD) at Imminent Risk of Suicide.
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