Pear Therapeutics Receives Expedited Access Pathway Designation

Pear Therapeutics received an expedited access pathway designation from the FDA for its reSET-O prescription digital therapeutic device to treat opioid use disorder.

The Smartphone application includes a web interface for clinicians and is intended to treat patients enrolled in outpatient treatment and on buprenorphine opioid replacement therapy.

In randomized clinical trials, reSET-O plus pharmacotherapy improved abstinence and increased program retention.