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Igalmi based on Dexmedetomidine sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Approved by FDA

The U.S. Food and Drug Administration ( FDA ) has approved Igalmi ( Dexmedetomidine ) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Igalmi can be self-administrated by patients under the supervision of a healthcare provider.

An estimated 7.3 million people in the U.S. are diagnosed with schizophrenia or bipolar disorders. Up to a quarter of these people experience agitation, with episodes that can occur 10 to 17 times annually, totaling up to 25 million agitation episodes for these two patient populations per year. Agitation episodes are associated with a significant burden for patients, caregivers, and the healthcare system.

The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group phase 3 trials evaluating Igalmi for the acute treatment of agitation associated with schizophrenia ( SERENITY I ) or bipolar I or II disorder ( SERENITY II ).

The primary endpoint was the mean change from baseline in the Positive and Negative Syndrome Scale - Excited Component ( PEC ) total score assessed at 2 hours following dosing.
The key secondary endpoint was the earliest time where efficacy, measured by the change from baseline in PEC score, was statistically separated from placebo.
PEC is an investigator-rated instrument for measuring agitation in patients that evaluates five elements associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement.

In both trials, Igalmi met the primary endpoint at two hours after the first dose in patients treated with the 120 mcg and 180 mcg doses, demonstrating statistically significant improvements from baseline.
Igalmi also met the key secondary endpoint, demonstrating a rapid onset of action, with statistically significant separation from placebo observed at 20 minutes for both the 180 mcg and 120 mcg doses in SERENITY II and 20 minutes and 30 minutes in SERENITY I, respectively.

The most common adverse reactions ( incidence greater than or equal to 5% and at least twice the rate of placebo ) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension and orthostatic hypotension.
All adverse drug reactions were mild to moderate in severity.
While Igalmi did not exhibit any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects including hypotension, orthostatic hypotension and bradycardia, QT interval prolongation, and somnolence.

Agitation is a common and difficult-to-manage symptom associated with bipolar I or II or schizophrenia. Early identification and prompt intervention to relieve agitation are essential to avoid symptomatic escalation and the emergence of aggression.
Expert consensus best-practice guidelines have recommended that agitation should be treated by a combination of behavioral calming techniques, verbal de-escalation, and medications that are voluntarily accepted by patients without coercion.
The goal of using medication is to calm the patient so that he or she can be more accurately assessed by clinicians. Medication used in this manner is consistent with current guidelines, which state that the proper endpoint of medication administration is calming without inducing sleep.
This approach may help avoid the costly and traumatic use of coercive techniques like physical restraint and seclusion, which may result in admission and prolonged hospitalization. ( Xagena )

Source: BioXcel Therapeutics, 2022