- Results showed that BXCL501 helped reduce withdrawal symptoms and could be as effective as or better than lofexidine.
- Patients receiving BXCL501 experienced more than a 30% reduction in withdrawal symptoms.
- BioXcel said BXCL501 could also be well-suited for treating withdrawal from opioids adulterated with xylazine.
Shares of BioXcel Therapeutics Inc (BTAI) gave up early gains to trade 5% higher on Thursday, after the company announced positive topline results from a Phase 2 trial evaluating BXCL501 for treating opioid withdrawal symptoms.
Results of the study, which involved 80 patients, showed that BXCL501 helped reduce withdrawal symptoms and may be as effective as or better than lofexidine, an FDA-approved treatment for opioid withdrawal.
BXCL501 Treatment Shows 30% Reduction In Withdrawal Symptoms
Patients receiving BXCL501 experienced more than a 30% reduction in withdrawal symptoms, with the strongest improvement seen on days three and four of treatment. The drug also showed a favorable safety and tolerability profile, with lower rates of certain cardiovascular side effects and no reports of sedation in the treatment groups.
These findings build on the company’s earlier Phase 1b/2 RELEASE study, which established the tolerability of selected BXCL501 doses in opioid-dependent patients, and expand the results to a different clinical setting that included a methadone taper and an active comparator.
BXCL501 could also be well-suited for treating withdrawal from opioids adulterated with xylazine, the company added.
“Opioid withdrawal remains a significant burden on the healthcare system and patients, and despite available therapies, there is still a substantial unmet need for safe and more effective treatment options that can help patients successfully transition to other medications such as buprenorphine or naltrexone for long-term benefits,” said Sandra Comer, Principal Investigator of the study and Professor of Neurobiology in the Department of Psychiatry at Columbia University.
How Did Stocktwits Users React?
Retail sentiment for BTAI flipped to ‘extremely bullish’ from ‘neutral’ a day earlier, amid ‘extremely high’ message volumes.
One user highlighted the company’s debt situation.
Year-to-date, the stock has gained around 7%
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