BioXcel Therapeutics reported mixed results in a study of its anti-agitation drug to treat opioid withdrawal syndrome, prompting a drop in its stock price.
The study found the drug to be safe and well-tolerated across multiple doses, although there were more adverse effects found in the highest (240 mcg) dose, compared to a placebo, the company reported.
The drug, BXCL501, fell short of its secondary goal to improve the ability of patients to complete opioid withdrawal treatment, however.
Patients taking either 120 or 180 mcgs of the BioXcel drug did show higher retention rates six days after the drug was administered — 42% and 52%, respectively, compared to 24% for those on a placebo. But the increase was not statistically significant, the company said.
There was also no improvement in the severity of opioid withdrawal symptoms.
But BioXcel said the drug still holds potential for treating the condition and the company is analyzing the data to determine its next steps.
In a statement, BioXcel Senior Vice President and Chief Development Officer Dr. Reina Benabou said the company was “very pleased with the tolerability of BXCL501 observed across multiple doses, twice-a-day and for consecutive treatment days in this study.”
She said the data “provides valuable insights as we explore additional indications and treatment settings that require multiple dosing regimens.”
The drug is a thin-film formulation of an older drug known as dexmedetomidine. It tastes minty and dissolves in the mouth, similar to a mouthwash strip.
BioXcel has applied for FDA approval of the drug for agitated patients with schizophrenia and bipolar disorder. It is also testing the drug to treat agitation associated with dementia and delirium.
BioXcel’s stock has been trading in the $35-$38 a share range this week, down from $43 before the results were released on March 31. It was trading at $35.9 as of Friday morning.
Contact Natalie Missakian at news@newhavenbiz.com
