Low-Dose Oral Film Reduces Mental Disorder Agitation

(Ulrike Mai, Pixabay. https://pixabay.com/photos/woman-desperate-sad-tears-cry-1006100/)

25 May 2023. Interim results from a clinical trial show a drug given as a dissolvable oral film in a lower dose reduces agitation in people with bipolar disorder and schizophrenia. Findings from the trial were released by Bioxcel Therapeutics Inc., developer of the drug Igalmi, testing half of the approved dose in a clinical setting, in advance of the second part of the study testing the drug among patients at home.

Bioxcel Therapeutics in New Haven, Connecticut discovers new applications of existing drugs with machine learning algorithms and analytics, which it says speeds development of new therapies at lower cost and with a greater likelihood of success. The company’s lead product, Igalmi, is an adaption of the drug dexmedetomidine first developed as a sedative in hospitals for intubation or mechanical ventilation. Bioxcel reformulates dexmedetomidine as a film dissolved under the tongue for individuals with mental health disorders who become overly agitated. The company says controlling agitation is difficult and can lead to aggression in some people if not addressed quickly.

In April 2022, the Food and Drug Administration approved Igalmi as a treatment for people with agitation from schizophrenia and bipolar disorder types 1 and 2; bipolar disorder type 2 is associated with major depressive disorder. FDA’s approval covers two dosage levels, 120 and 180 micrograms, taken by the patients themselves but under the supervision of clinicians.

Lower scores on agitation scale

The new clinical trial is testing Igalmi in a lower dose, 60 micrograms — code-named BXCL501 — as an eventual treatment for agitation that can be taken at home, without supervision by trained staff. Bioxcel designed the late-stage trial in two parts: first in a clinical setting, then by patients at home. The entire trial will enroll 450 participants diagnosed with bipolar disorders type 1 and 2, schizophrenia, and related conditions at 16 sites in the U.S. Participants are randomly assigned to receive BXCL501 or a placebo, then assessed in the next few hours and tracked for 12 weeks.

Bioxcel released results today of the study’s first phase — with 201 participants taking BXCL501 or placebo under clinical supervision — on its web site and are not yet peer-reviewed. Results show none of the BXCL501 recipients experienced severe adverse effects, with any adverse effects rated mild or moderate, and none requiring medical intervention or monitoring. The most common adverse effect was drowsiness or fatigue, experienced by 13 of the 101 BXCL501 recipients.

The company says results of standard clinical assessments of agitation show lower scores among participants receiving BXCL501 than placebo recipients at two and four hours after taking the drug, compared to before the trial, but only the differences between the groups after four hours are large enough for statistical reliability. The number of participants responding to treatments, defined as a 40 percent or larger reduction on the same standard agitation assessment scale, is greater for BXCL501 than placebo recipients at two hours after taking the drug, compared to before the trial.

“We believe these results have opened the therapeutic window for BXCL501’s potential use at home for bipolar- and schizophrenia-related agitation,” says Bioxcel Therapeutics’ chief medical officer for neuroscience Robert Risinger in a company statement. Company CEO Vimal Mehta adds, “Treatment in the early stages of agitation at home could significantly benefit patients, caregivers, and hospital systems by reducing the need for emergency room visits and associated treatment costs.”

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