LivaNova’s Study of Neurostim to Treat Depression Misses Primary Endpoint

LivaNova released the preliminary results for the unipolar patient cohort for its RECOVER study assessing its VNS Therapy for treatment-resistant depression.
 
The study didn’t meet its primary endpoint for the cohort but “statistical significance” was achieved in some secondary endpoints.
 
The primary endpoint measured the difference between active and sham VNS Therapy on the rate of Montgomery–Åsberg Depression Rating Scale (MADRS) response for the unipolar patient cohort with a predetermined p-value of p<0.023. The active treatment arm showed meaningful improvement from the treatment arm’s baseline.
 
However, a strong response in the sham group that the company said was unforeseen in the study design caused statistical separation to not be achieved between the two arms by the study’s end. LivaNova said despite this, the data’s totality supported meaningful treatment in active VNS Therapy because the trial’s population had a significant unmet need due to failure of numerous other treatment modalities.
 
The company plans to publish the unipolar cohort data in peer-reviewed journals in Q4 2024. No safety issues were reported. The RECOVER bipolar patient cohort is ongoing and LivaNova said it will continue discussions with CMS regarding VNS Therapy’s coverage reconsideration for treatment-resistant depression.
 
“We would like to thank the patients and physicians who participated in RECOVER to date, as well as the U.S. Centers for Medicare and Medicaid Services, who we partnered with to design this study,” said Vladimir Makatsaria, CEO of LivaNova. “Despite not achieving statistical significance for the primary endpoint for the unipolar cohort in the RECOVER study, the effect of active VNS Therapy was within our expectations and resulted in clinically meaningful benefits in select secondary endpoints. We are conducting an in-depth analysis of the data with key stakeholders and will determine the path forward in the coming weeks.”