Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner’s National Priority Voucher
Compass Pathways plc a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass’ proprietary formulation of synthetic psilocybin, for the Commissioner’s National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). Companies selected for the voucher program will be entitled to benefits including enhanced communications and a shortened 1-2 month review time following filing of a New Drug Application (NDA), while maintaining FDA’s rigorous safety and efficacy standards.
We are honored and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “As the most advanced company in the classic psychedelics field, Compass has generated positive data from two large, well controlled Phase 3 clinical trials. Based on the strength of our data, the FDA granted us a rolling NDA submission and review.
Importantly, while the CNPV may provide process efficiencies and accelerated review timelines, an NDA submission must still meet FDA’s established standards of clinical evidence, scientific rigor, and regulatory compliance. We are confident we meet these standards.
Nath continued, “Patients with TRD often endure years of persistent suffering with limited options, and the need for meaningful innovation for these patients has never been more urgent. We are well advanced in our commercial preparations and the CNPV could further accelerate momentum toward bringing our transformative treatment, if approved, to patients who have been waiting far too long.
COMP360’s transformative clinical profile
COMP360 is the first classic psychedelic1 to consistently achieve a highly statistically significant result and clinically meaningful effect in two phase 3 studies, with a generally well-tolerated and safe profile. With data generated across more than 1,000 participants living with TRD, COMP360’s transformative clinical profile is redefining rapidity and durability for TRD patients. Unlike any other approved treatment available for this patient population today, COMP360 may demonstrate effects as quickly as within one day after administration with durability lasting at least through 6 months for those who achieve a clinically meaningful response after one or two doses.
With respect to COMP360’s safety profile, a significant majority of treatment-emergent adverse events (TEAEs) are mild or moderate in severity, and the vast majority resolve within 24 hours.
About treatment resistant depression (TRD)
Depression, one of the most common mental health disorders, significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030.
It is estimated that approximately 4 million patients in the U.S. with MDD live with TRD2. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD.
About Compass Pathways
Compass Pathways plc is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
Source link: https://www.businesswire.com/
