The study focuses on the lowest approved dose of IGALMI® (120mcg) and aims to support a supplemental new drug application (sNDA) for label expansion in the home setting. Topline data is expected in the second half of 2025. Currently, there are no FDA-approved therapies for acute agitation treatment at home, despite an estimated 23 million annual episodes associated with bipolar disorders or schizophrenia in the U.S.
3 Likes
that sounds like something that could really be useful, maybe then docs will stop giving loads of benzos like its candy.
3 Likes