Milestone Announcement for Motivista Approval
We at Premier Clinical Research, Inc are proud to announce yet another a significant achievement: the FDA has cleared Click Therapeutic's Motivista (CT-155), the first treatment specifically for the negative symptoms of schizophrenia. This accomplishment is a testament to the hard work of nearly 90 investigative sites, including ours.
For too long, treatments have focused on positive symptoms of schizophrenia, leaving negative symptoms like low motivation and social withdrawal inadequately addressed. Motivista marks a crucial advancement for patients who have needed better options. This FDA authorization highlights the potential of digital medicine in the future.
The FDA's decision was backed by the Phase III CONVOKE study (NCT05838625), which showed that patients using Motivista experienced significantly greater improvements in negative symptom severity compared to a digital control application. The results demonstrated a 62% relative improvement in negative symptoms, along with a favorable safety profile.
Negative symptoms affect around 60% of the 24 million people with schizophrenia worldwide, leading to higher healthcare costs and poorer outcomes. Motivista, which is delivered via smartphone, complements clinician-managed antipsychotic therapy and combines evidence-based psychosocial therapies with innovative digital methods.
While Motivista is not yet commercially available, Click Therapeutics is preparing for its launch to market. For updates on product status, please visit motivista.com.
The team here at PCRI are all so pleased to have been able to contribute to another FDA approval. We remain committed to finding and supporting ground-breaking advances in healthcare because we really do believe in a healthier tomorrow.
Comments