Pear’s schizophrenia app reaches the market – temporarily

Pear Therapeutics has launched its fourth product, a prescription app for patients with schizophrenia, after the FDA loosened the rules governing digital health products as a response to the Covid-19 pandemic. Pear-004 has not been approved in the US or even studied in a pivotal trial, but the FDA’s recent enforcement policy for psychiatric digital health devices means that this is not necessary. The policy aims to boost app use to reduce contact between patients and healthcare providers, but will remain in effect only for the duration of the public health emergency related to Covid-19; when that ends Pear will have to obtain formal approval, as it did with its three other marketed apps. Pear-004 provides neurobehavioral interventions such as social skills training, cognitive behavioural therapy for psychosis, and illness self-management training, and was developed in collaboration with Novartis under a deal that also covers a multiple sclerosis app. Novartis, however, does not appear to be involved in Pear-004’s release.

Selected candidates in Pear's pipeline
Product Indication Status Partner
Reset Substance use disorder Marketed None; formerly Sandoz
Reset-O Opioid use disorder Marketed None; formerly Sandoz
Somryst Insomnia/depression Marketed None
Pear-004 Schizophrenia  Marketed (temporarily) Novartis
Pear-007 Pain Proof of concept None
Pear-006 Multiple sclerosis Discovery Novartis
Unnamed GI disorders Discovery Ironwood Pharmaceuticals
Source: company website.

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