BioXcel Therapeutics' Approved Drug For Bipolar Disorders/Schizophrenia Shows No Evidence Of Worsening Or Withdrawal In Post-Marketing Study

Tuesday, BioXcel Therapeutics Inc BTAI released topline results from a post-marketing requirement (PMR) study of Igalmi (dexmedetomidine) sublingual film that demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of PRN (as-needed) treatment.

In the single-arm, open-label study, 28 inpatient adults with frequent episodes of agitation associated with bipolar disorders or schizophrenia self-administered 180 mcg dose of Igalmi as needed over seven days. A total of 83 episodes were treated.

Although the study was not statistically powered to evaluate repeat-dose efficacy, changes in agitation were assessed through the Positive and Negative Syndrome Scale-Excitatory Component (PEC or PANSS-EC) Score and the Clinical Global Impressions – Improvement (CGI-I) Scale, the same measures as used in previous Phase 3 studies.

Mean PEC score reduction was observed following all doses of Igalmi administered as needed over the treatment period.

All patients showed improvement in agitation symptoms for all doses administered as needed over the treatment period.

Before treatment with Igalmi, most patients exhibited mild to moderate agitation as assessed by the Agitation Calmness Evaluation Scale (ACES).

ACES scores post-dose revealed a marked calming effect, with no patient experiencing unarousable somnolence.

In addition, no withdrawal or rebound phenomena were observed.

The 180 mcg dose of Igalmi was generally well tolerated and showed favorable safety results in treating patients with frequent episodes of agitation.

There were no discontinuations due to adverse events. No serious adverse events were reported.

“We are pleased these study findings showed consistent responses to PRN treatment for episodes of agitation over the study duration with no evidence of worsening or withdrawal,” said Rob Risinger, Chief Medical Officer of Neuroscience.

Price Action: BTAI shares are up 2.10% at $1.215 at last check Tuesday.

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