BioXcel drug shows promise in reducing agitation in those with bipolar disorder

An investigational drug from New Haven’s BioXcel Therapeutics showed strong results in reducing the agitation associated with bipolar disorder, the company reported Tuesday.

The drug, BXCL501 (sublingual dexmedetomidine), significantly reduced agitation at doses of  120 mcg and 180 mcg compared with a placebo, according to study results.  

BXCL501 is administered in an orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2 receptor agonist for the treatment of agitation associated with neuropsychiatric disorders, the company said in a statement. 

The Phase 3 trial results were reported in the Journal of the American Medical Association.

The BioXcel drug shows promise as a noninvasive and patient-administered treatment for agitation, said the study’s author, Dr. Sheldon H. Preskorn of the University of Kansas School of Medicine-Wichita.

“This research is an important milestone in the development of a patient-centric treatment approach for agitation – a difficult-to-manage symptom associated with many psychiatric and medical conditions,” Preskorn said. 

Agitation presents as a common symptom of neuropsychiatric conditions including bipolar disorders I and II and schizophrenia, which are diagnosed in an estimated 7.3 million people in the U.S.

“A non-invasive therapy that causes rapid and sustained symptom relief may be helpful to avoid the costly and traumatic use of coercive techniques, like physical restraint and seclusion, which may result in admission and prolonged hospitalization,” according to a BioXcel statement. 

Another BioXcel investigational drug, BXCL701, showed good results in a study in patients with a rare and aggressive form of prostate cancer, the company reported earlier this month.

Contact Liese Klein at lklein@newhavenbiz.com.