Bethlem Royal Hospital

Mindfulness-Based Cognitive Therapy Shows Promise for Treatment-Resistant Depression

10 days ago

• A new clinical trial published in Lancet Psychiatry demonstrates that mindfulness-based cognitive therapy (MBCT) significantly improves symptoms in patients with difficult-to-treat depression compared to standard care. • The eight-week MBCT program delivered via videoconference was found to be cost-effective at less than £100 per person, potentially saving healthcare systems money while providing a viable treatment option for patients who haven't responded to conventional therapies. • Researchers from the University of Surrey, University of Exeter, and University of Sussex report that MBCT's effectiveness is comparable to antidepressants, offering new hope for the approximately 50% of depression patients who remain symptomatic after completing standard psychological treatments.

Awakn's AWKN-002 Receives FDA Support for Phase 2b Trial in Alcohol Use Disorder

4 months ago

• Awakn Life Sciences received FDA support to advance AWKN-002, an oral thin film esketamine, to a Phase 2b trial for moderate to severe Alcohol Use Disorder (AUD). • The FDA confirmed that no additional clinical data is required before initiating the Phase 2b trial, streamlining the development pathway for AWKN-002. • AWKN-002 is eligible for review under the 505(b)(2) NDA pathway, potentially granting up to 5 years of market exclusivity in the U.S. for AUD treatment. • Awakn plans to submit an IND application for AWKN-002 in H2 2025, followed by a Phase 2b trial application in H1 2026, aiming to address the unmet needs in AUD treatment.

Awakn Expands Phase 3 Trial of AWKN-001 for Severe Alcohol Use Disorder with New Sites

7 months ago

• Awakn Life Sciences has broadened its Phase 3 trial for AWKN-001, a treatment for severe Alcohol Use Disorder (AUD), by adding four new clinical trial sites in the UK. • The MORE-KARE trial will assess the efficacy of AWKN-001, which combines intravenous ketamine with psychosocial support, aiming to reduce alcohol relapse in severe AUD patients. • This pivotal study, co-funded by the UK's Medical Research Council and Awakn, is the largest of its kind to investigate ketamine-assisted therapy for AUD. • AWKN-001 previously demonstrated promising results in a Phase 2 trial, achieving 86% abstinence over six months post-treatment, marking a significant improvement over pre-trial outcomes.