The FDA has granted 510(k) clearance to Motivista, a prescription digital therapeutic developed by Click Therapeutics, as an adjunctive treatment for negative symptoms of schizophrenia. Delivered via smartphone, Motivista is the first digital therapeutic approved for symptoms like avolition and anhedonia. In the phase III CONVOKE trial of 457 adults, Motivista users showed a 6.8-point improvement in symptom severity compared to 4.2 points in the control group. Click Therapeutics is now seeking Medicaid coverage to ensure patient access.
FDA clearance of Motivista
- ▪Motivista is the first prescription digital therapeutic cleared by the FDA specifically for the treatment of negative symptoms of schizophrenia.
- ▪The FDA granted 510(k) clearance to Motivista, a prescription digital therapeutic developed by Click Therapeutics, as an adjunctive treatment for adults with negative symptoms of schizophrenia.
Results of the CONVOKE study
- ▪Serious adverse events occurred in 1.3% of Motivista users and 2.2% of control participants, with none considered related to the treatment.
- ▪In the CONVOKE study, Motivista users achieved a 6.8-point improvement in negative symptoms compared to 4.2 points for the control group at 16 weeks.
- ▪The FDA clearance of Motivista was supported by the phase III CONVOKE study, which evaluated 457 adults experiencing negative symptoms of schizophrenia.
- ▪The CONVOKE study reported adherence rates of 70.4% for the Motivista treatment group and 76.5% for the control group at week 15.
How Motivista is used
- ▪Patients use the Motivista smartphone application at home for 16 weeks as an adjunct to clinician-managed outpatient antipsychotic therapy.
- ▪Click Therapeutics warned that Motivista is not for acute symptoms, active suicide risk, patients under age 18, or those not taking antipsychotics.
- ▪Motivista delivers cognitive behavioral therapy techniques, including cognitive restructuring, behavioral activation, social skills training, and positive affect training, via lessons and daily check-ins.
Motivista insurance coverage
- ▪Access to Motivista depends on state-level coverage decisions, which are critical because Medicaid covers a significant share of adults with schizophrenia.
- ▪Click Therapeutics is engaging state decision-makers and federal representatives to secure Medicaid and pharmacy benefit coverage for Motivista.
The challenge of negative symptoms
- ▪Unmanaged negative symptoms of schizophrenia often lead to increased healthcare utilization, higher medical costs, and poorer patient outcomes.
- ▪Standard schizophrenia treatments typically address positive symptoms like hallucinations, delusions, and disorganized thinking, leaving negative symptoms with few approved therapies.
- ▪Negative symptoms of schizophrenia, which affect approximately 60% of patients, include avolition, anhedonia, and asociality, and often persist when positive symptoms are well-controlled.
Debatable claims
- ▪Motivista's clinical trial results justify public insurance coverage
- ▪Digital therapeutics for schizophrenia reduce overall healthcare costs
- ▪State Medicaid programs should grant protected class status to Motivista
Story comments
Loading comments…