-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On February 22, BioXcel announced that the results of a pivotal Phase III clinical trial of BXCL501 (sublingual dexmedetomidine) for the treatment of acute agitation symptoms associated with bipolar disorder were published in the Journal of the American Medical Association (JAMA)
BXCL501 is an investigational, proprietary oral-dissolving film formulation whose active ingredient is dexmedetomidine, a selective α2 receptor agonist, for the treatment of agitation symptoms associated with neuropsychiatric disorders
Agitated symptoms were significantly reduced in the BXCL501 120 mcg and 180 mcg groups compared with placebo after 2 hours of treatment, as measured by the change from baseline in the positive and negative psychiatric symptom rating scale-agitation state (PEC) total score
Specifically, for the primary endpoint, after 2 hours of treatment, the mean PEC total score change from baseline was -10.
On the prespecified exploratory endpoint, 90.
In terms of safety, the incidence of adverse events (AEs) for sublingual dexmedetomidine 180 mcg and 120 mcg was 35.
BioXcel has previously submitted a marketing application to the FDA based on the results of this study, with a PDUFA date of April 5, 2022
At present, the most widely used clinically is dexmedetomidine injection, which is used for sedation during tracheal intubation and mechanical ventilation
