Business
BioXcel Therapeutics Announces Positive Topline Results from Post-Marketing Requirement Study Evaluating PRN Treatment of IGALMI™ (dexmedetomidine) Sublingual Film for Agitation Associated with Bipolar Disorders or Schizophrenia
Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose) For each
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose) For each episode occurring over seven days, a reduction in agitation was observed and no serious adverse events were reported following treatment Results supportive of Phase 3 SERENITY and TRANQUILITY programs NEW HAVEN, Conn., June 25, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced positive 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. “We are encouraged by these study results showing a lack of tachyphylaxis, tolerance, and withdrawal at the highest approved dose of IGALMI for patients experiencing frequent episodes of agitation,” said Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics. “This new dataset may help address potential changes to the language in the current label. This dataset also adds to our body of evidence for our lead neuroscience asset as we prepare to advance our Phase 3 SERENITY and TRANQUILITY trials.” PMR Study Methods and Topline Results 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. Efficacy Measurements: although this PMR 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 (see graph below).All patients showed improvement in agitation symptoms as assessed by the CGI-I Scale for all doses administered as needed over the treatment period.Prior to treatment with IGALMI, most pat...