Expert Interview
Discussing BioXcel’s BXCL501 for Agitation Associated with Schizophrenia and Bipolar Disorders, following PDUFA date extension by 3 months to April 5, 2022
Ticker(s): BTAIInstitution: Columbia University
- Associate Professor of Clinical Psychiatry and Director of the Columbia Schizophrenia Research Center (CSRC)
- Research career is investigating novel pharmacological and sensory-based treatments for core neurocognitive dysfunction in schizophrenia.
- Research has demonstrated that NMDAR dysfunction may contribute to underlying neuroplasticity deficits; has also conducted numerous early stage, target engagement biomarker studies with novel therapeutics using neurophysiological and neuroimaging biomarkers.
Please describe your clinical practice. How many patients with NERD do you currently manage? What is the most common symptom in your patients, from motor restlessness, increased response to external stimuli, irritability, and unsuitable speech?
Can you tell us about the patients’ compliance rate with the treatment? How much of a problem is there in that regard and what could help them?
Can you please discuss the SERENITY II Pivotal Phase 3 Results, where:-The mean changes from baseline in PEC total score two hours after treatment were -10.4 (4.4) for sublingual dexmedetomidine 180 mcg and -9.0 (5.3) for 120 mcg, compared with -4.9 (4.7) for placebo.-On the key secondary endpoint, statistically significant treatment effects were first evident 20 minutes after initial treatment for both doses (P = .007 for 180 mcg; P = .009 for 120 mcg) compared with placebo. Patients in both treatment groups showed greater improvement in the PEC total score than patients in the placebo group at all subsequent time points through 120 minutes after treatment.-On prespecified exploratory endpoints, 90.5% and 77.0% of patients in the 180 mcg and 120 mcg BXCL501 treatment groups, respectively, experienced a treatment response at two hours, defined as at least 40% improvement from baseline on PEC score. In the placebo group, 46% were treatment responders.
Can you please tell us your opinion on the reported incidence of adverse events, which stood at 35.7% for sublingual dexmedetomidine 180 mcg and 34.9% for 120 mcg vs 17.5% for placebo. The most commonly reported AEs were somnolence, dry mouth, hypotension, and dizziness. How serious is the cause for concern here?
What arguments would tilt the balance to switching to BXCL501 for your patients?
Added By: catalin_adminOpioid withdrawal symptoms with BXCL501 iis pending NIDA grant decision, and agitation in delirium study with BXCL501 is on voluntary pause. Could you please discuss the potential risk profile of the drug?
How much of an advantage is therere to BTAI's proprietary, orally dissolving thin film formulation of dexmedetomidine? How does it compare to standard of care?
According to the company’s polling, 83% of HCPs surveyed have a positive impression of BXCL501, and would consider prescribing for 40% of their accessible acute agitation population, vs Benzodiazepines - 38%, Typical Antipsychotics 34% and Atypical antipsychotics at 29%. How accurately do those numbers depict the reality you’ve seen in clinic?
How likely are you to prescribe BXCL501, if approved?
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