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Recently, the biopharmaceutical company BioXcel Therapeutics announced that the FDA approved Igalmi for the treatment of schizophrenia or bipolar disorder (type I or II)
FDA
Formerly known as manic-depressive disorder, bipolar disorder is a mental health disorder that can cause extreme mood swings, including high moods (mania or hypomania) and low moods (depression)
Treatment for bipolar disorder includes medications to stabilize mood (mood stabilizers, such as lithium and certain antiseizure medications), antipsychotic medications, some antidepressants, psychotherapy, education, and support
The drug, expected to launch later this quarter, will be self-administered by patients under the supervision of a healthcare provider
Patients met the primary endpoints of both studies two hours after receiving Igalmi at doses of 120 μg and 180 μg
The drug also exhibited rapid onset of action, with the 180 μg dose being significantly different from placebo at 20 minutes in SERENITY I and the 120 μg dose at 30 minutes; and in SERENITY II, Both doses were significantly different from the placebo group at 20 minutes
BioXcel is also developing Igalmi for the acute treatment of Alzheimer's disease and the adjunctive treatment of major depressive disorder
Original source:
Original source:https://firstwordpharma.
https://firstwordpharma.
com/story/5542437 https://firstwordpharma.
com/story/5542437
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