An app becomes the first FDA-cleared treatment for schizophrenia's negative symptoms
Click Therapeutics said Monday the FDA has cleared Motivista, a prescription phone app, as the first treatment aimed at schizophrenia's negative symptoms, such as low drive and pulling away from people. It is used alongside antipsychotic drugs. In a 16-week trial, it beat a control app by 2.6 points on a 36-point scale.
A smartphone app is now the first FDA-authorized treatment aimed at the negative symptoms of schizophrenia. Click Therapeutics announced Monday that the FDA cleared Motivista for adults whose hallucinations and delusions are stable. It is meant to be used alongside a doctor's care and antipsychotic medicine.
Negative symptoms are the hard part for many patients. They include low motivation, trouble feeling pleasure and pulling away from other people. Current drugs mostly treat the "positive" symptoms, such as hallucinations. Until now, no treatment was authorized for negative symptoms.
The app runs a 16-week program. Patients use it for about an hour a week, the company says, alongside their regular care.
The evidence is real but modest. In the main trial, 457 adults at 66 U.S. sites used Motivista or a control app. Scores on a 36-point scale fell 6.8 points with Motivista and 4.2 points with the control. Click calls that a "62% relative improvement." Behavioral Wire points out the 2.6-point gap is about 7% of the scale. Patients' own ratings of improvement did not differ much from the control group by week 16.
Safety questions were limited. One participant had two short flare-ups of schizophrenia that study doctors rated possibly related to the app.
Price and access are open questions. Click has not announced a price or launch date. Its sales chief, Richard DeNunzio, told Fierce that the launch "follows coverage," state by state, because Medicaid covers many adults with schizophrenia. In the trial, 64% of participants reported income under $25,000, Behavioral Wire found.
Here's the backstory. The FDA actually cleared the app July 30 through its 510(k) device pathway, a different test than drug approval. It found the app similar to Click's earlier depression app, Rejoyn. Drugmaker Boehringer Ingelheim handed full rights to Click in April along with a $50 million investment. Digital therapy firms have struggled before; Pear Therapeutics went bankrupt in 2023 after trouble getting insurers to pay.
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What we know: Motivista is cleared for adults with stable positive symptoms, alongside medicine.
What we don't: Its price, when patients can get it, and whether insurers will cover it.
Where outlets agree Fierce Biotech and Behavioral Wire both report the clearance covers adults with stable positive symptoms who use the app alongside clinician-managed antipsychotic treatment.
Where they differ Click calls the trial result a 62% relative improvement, while Behavioral Wire notes the 2.6-point gap is about 7% of the scale and patients' own ratings did not differ significantly at 16 weeks.