April 6, 2022

Igalmi™ (dexmedetomidine) sublingual film, made by BioXcel Therapeutics, has received FDA approval to treat agitation associated with schizophrenia or bipolar I or II disorder in adults.

  • According to the manufacturer, “Igalmi is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a ” The active pharmaceutical ingredient is the same as in Hospira’s Precedex®, an FDA-approved intravenous medication used to provide sedation in clinical settings.
  • Under the prescribing information, Igalmi can be given in three doses, each spaced two hours apart, in one 24-hour The number of doses and total daily dose are determined by factors that include:
    • The severity of agitation;
    • Whether the patient has hepatic impairment;
    • Whether the patient is over or under 65 years of age;
    • The patient’s blood pressure and heartrate; and
    • The patient’s treatment
  • Igalmi should be used under the supervision of a healthcare provider, and patient vital signs and alertness should be monitored by a healthcare provider following administration. It is given by buccal (placed against the inside of the cheek and allowed to dissolve) or sublingual (placed under the tongue and allowed to dissolve) administration.
  • BioXcel plans to launch the product during the second quarter of 2022.
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