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BioXcel Stock Is Trading Lower After BXCL501 Data In Opioid Withdrawal Study

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BioXcel Stock Is Trading Lower After BXCL501 Data In Opioid Withdrawal Study
  • BioXcel Therapeutics Inc (NASDAQ: BTAI) has announced topline results from its Phase 1b/2 proof-of-concept RELEASE study evaluating BXCL501 for the treatment of opioid withdrawal symptoms.
  • BXCL501 is the Company's proprietary, orally dissolving thin film formulation of dexmedetomidine.
  • The study met its primary safety endpoint across multiple doses (30 mcg to 240 mcg) given twice-daily over seven days. BXCL501 was well tolerated.
  • The highest BXCL501 (240 mcg) dose was associated with cardiovascular and nervous system treatment-emergent adverse events, versus none in the placebo group.
  • Concerning retention, a secondary endpoint, the study showed that patients in multiple-dose cohorts treated with BXCL501 had numerical improvements in retention rates, a key goal of opioid withdrawal treatment.
  • The 120 mcg and 180 mcg dose groups showed 42% and 52% retention rates at Day 6 of BXCL501 treatment, respectively, versus 24% for placebo, though observations were not statistically significant.
  • The results also showed that of the 87% of patients who had fentanyl in their systems upon entry, greater than 50% remained fentanyl positive following the morphine stabilization phase of 5 days.
  • Consequently, withdrawal symptoms were not equivalent across various dose cohorts indicating morphine did not normalize withdrawal symptoms.
  • Improvements were not observed in the severity of opiate withdrawal.
  • The Company believes that the high fentanyl prevalence and lack of normalization observed in study subjects could have confounded these results and made them difficult to interpret.
  • Price Action: BTAI shares are down 7.7% at $39.86 in the premarket session on the last check Thursday.
 

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Posted-In: OpioidBiotech News Health Care Small Cap FDA General

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