BioXcel Therapeutics has completed the last patient visit in its pivotal Phase 3 SERENITY At-Home trial of BXCL501 (dexmedetomidine) for acute agitation in bipolar disorder and schizophrenia patients in the at-home setting. Topline data are expected this month and will inform a supplemental New Drug Application (sNDA) for this expanded indication.
The completion of this trial marks a significant step in BioXcel’s strategy to address the unmet need for at-home treatment of acute agitation. Currently, no FDA-approved therapies exist for this indication, despite an estimated 23 million at-home episodes annually in the U.S. The trial’s focus on the at-home setting reflects the growing trend toward decentralized trials and aligns with patient preference for less disruptive care.
The SERENITY At-Home trial design—double-blind, placebo-controlled, evaluating safety of a 120 mcg dose in over 200 patients across 22 sites—indicates a focus on minimizing site burden and ensuring geographically diverse data collection. This approach may be particularly relevant given ongoing challenges in site staffing and patient recruitment. The balanced distribution of patients between bipolar disorder and schizophrenia also addresses the increasing regulatory emphasis on subgroup analysis and potentially broadens the drug’s market reach.
This at-home treatment paradigm poses significant challenges. Patient monitoring and data collection in uncontrolled environments require robust remote monitoring technologies and patient/caregiver training. Furthermore, regulatory acceptance hinges on demonstrating safety and efficacy without the direct oversight of healthcare professionals typically present in traditional clinical settings.
The success of this trial could reshape the agitation management landscape, potentially opening a new market for pharmaceutical companies and providing patients with a more convenient and less stigmatizing treatment option. The market’s response will depend on efficacy data, the robustness of the safety profile, and payer acceptance of a home-based treatment model. The ability to administer BXCL501 at home could offer significant advantages for patients and caregivers while potentially reducing the burden on emergency departments and other healthcare facilities. Further data analysis and regulatory feedback will clarify the impact of this potential paradigm shift.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
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4 months ago[…] BioXcel Therapeutics has successfully concluded a trial exploring in-home monitoring and treatment for bipolar disorder and schizophrenia-related agitation. This initiative marks a pivotal shift from conventional hospital-based interventions to patient-centered, remote care. The study demonstrated the feasibility of delivering treatment in a home setting without compromising safety or outcomes (source). […]