LivaNova said that its VNS Therapy for treatment-resistant depression has failed to meet the primary endpoint (PE) in the unipolar cohort of the RECOVER clinical study.
However, LivaNova said that the therapy achieved statistical significance in select secondary endpoints.
The VNS Therapy System is designed for the long-term treatment of chronic or recurrent depression in patients aged 18 or older.
The US Food and Drug Administration (FDA)-approved therapy is intended for those experiencing a major depressive episode and who did not respond adequately to four or more antidepressant treatments.
LivaNova started the RECOVER trial in September 2019 and is evaluating over 1,000 patients with difficult-to-treat unipolar or bipolar depression.
The double-blind, randomised controlled study is currently evaluating the potential of VNS Therapy to alleviate depressive symptoms and enhance the quality of life for patients.
It is being conducted at approximately 100 prominent hospitals and medical centres across the US.
The primary endpoint compared the effects of active and sham VNS Therapy on the rate of Montgomery–Åsberg Depression Rating Scale (MADRS) response.
Over the 12 months, the active treatment group demonstrated statistically significant and clinically meaningful improvements from their baseline.
However, strong responses in the sham group resulted in a lack of statistical differentiation between the treatment and sham arms at the end of the study.
Furthermore, the collective data indicates a meaningful treatment effect for those receiving active VNS Therapy.
The Nasdaq-listed medical technology firm plans to release the unipolar cohort data, along with specifics regarding the primary endpoint and secondary endpoints in Q4 2024.
LivaNova CEO Vladimir Makatsaria said: “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.”
The RECOVER study’s bipolar patient cohort is currently ongoing.
LivaNova intends to continue its discussion with the US Centers for Medicare and Medicaid Services (CMS) for reconsideration of coverage for VNS Therapy to treat depression.
