Teva Pharmaceuticals International GmbH has completed its acquisition of assets from BioXcel Therapeutics, Inc.

 

This, including worldwide rights to BXCL501, an investigational drug that could become the first FDA-approved treatment for acute agitation associated with schizophrenia or bipolar I or II disorder that patients can use at home.

 

The acquisition strengthens Teva Pharmaceutical Industries Ltd.’s neuroscience pipeline with a late-stage candidate targeting a significant unmet medical need. BXCL501, a dexmedetomidine sublingual film, is currently under review by the US FDA for at-home use in adults experiencing acute agitation linked to these conditions.

 

If approved, the treatment could offer patients an alternative to seeking care in emergency departments or hospitals when agitation escalates.

 

“Business development plays an important role in accelerating our Pivot to Growth strategy by bringing targeted external innovation into Teva,” said Evan Lippman, Executive Vice President, Business Development at Teva. “BXCL501 is a strong strategic fit with our neuroscience portfolio and reflects our disciplined focus on differentiated, late-stage opportunities that address unmet patient needs and create long-term value for Teva’s shareholders.”

 

The need for new treatment options is substantial. Acute agitation affects an estimated 25% to 40% of patients with schizophrenia or bipolar I or II disorder, according to the company. Episodes can escalate rapidly, placing considerable strain on patients, families and caregivers and potentially leading to emergency department visits or hospitalisation.

 

Treatment options remain limited, particularly outside healthcare settings, underscoring the potential importance of a therapy designed for use at home.

 

“Agitation can escalate quickly, which is why the ability to intervene early matters,” said Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “If approved, BXCL501 could give adults living with schizophrenia or bipolar I or II disorder the ability to treat agitation at home, closer to the moment symptoms emerge and before they could become more difficult to manage.”