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FDA approves Igalmi for schizophrenia or bipolar disorder

 Last Update: 2022-05-24
 Source: Internet
 Author: User

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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:

https://firstwordpharma.

https://firstwordpharma.
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