Dive Brief:

• Pear Therapeutics is set to present top-line data from a clinical trial of its digital therapeutic treatment for opioid use disorder.

• The app, reSET-O, is designed to help people who are on buprenorphine opioid replacement therapy abstain from opioid use and remain in the treatment program.

• Pear's substance use apps, one of which is already on the market, are designed to improve abstinence by supporting patients and incentivizing them to stay in the program.

Dive Insight:

Opioid use disorder has been on Pear's roadmap for years but its work on the indication has moved forward more slowly than its broader substance use efforts. Investigators enrolled more than 100 patients who reported opioids as their primary substance of abuse in the clinical trial that supported FDA's de novo clearance of reSET but the software performed better outside the opioid subgroup.

Across all 255 patients in reSET are of the the trial, 30% of people were abstinent in weeks nine to 12 of the study. When 49 people who primarily used opioids were removed from the analysis, the abstinence rate jumped to 40%.

The findings led FDA to state "reSET was not demonstrated to be effective for patients reporting opioids as their primary substance of abuse" in its De Novo assessment of the software. That led to reSET heading to market as a prescription app for patients with substance use disorder, provided their primary substance of abuse is something other than opioids.

Pear's pitch for the opioid use disorder market now rests on reSET-O, a version of the app tailored for use by people who are addicted to the painkillers. FDA is currently reviewing a 510(k) filing for clearance of the breakthrough-designated opioid app.

Ahead of the FDA decision, Pear has arrived at the annual meeting of the American Academy of Addiction Psychiatry with top-line data from a clinical trial of reSET-O. Pear will present the data on Friday but shared some snippets in its preview release, including the claim that the app improved treatment retention. The trial collected urine drug tests but Pear is yet to comment on those data.

The readout comes as Pear and its partner on reSET and reSET-O, Novartis' Sandoz, seek to turn the FDA-cleared app into a commercial success. Sandoz began selling reSET last month. Pear will use the meeting the present new analyses of the data that supported the FDA authorization of reSET.