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 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 int
Read More
“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. 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.”
Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics