Pear Therapeutics has received FDA 510(k) clearance for its reSET-O medical application that helps treat patients who have an opioid use disorder.
The reSET-O app is a prescription cognitive behavioral therapy that is designed to be used with outpatient treatment and under the care of a healthcare professional. It is also designed to be used with a treatment that includes buprenorphine and contingency management.
“As part of our efforts to address the misuse and abuse of opioids, we’re especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addiction. Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts. That’s why, for example, we launched an innovation challenge earlier this year to promote the development of medical devices that could help treat addiction,” Scott Gottlieb, the FDA’s commissioner, said in a press release.
The reSET-O app is can be downloaded directly to a patient’s mobile device after they receive a prescription from their doctor. It is designed to be used with an outpatient opioid use disorder treatment program. It is a training , monitoring and reminder tool for healthcare providers and patients to make treatment more engaged. It also has a compliance reward system where patients can earn special icons on a prize wheel within the app.
“Often on the road to recovery, patients find their commitment to staying in treatment may wane. Providing Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed. We know medication-assisted treatment works and we support novel ways to keep individuals more engaged in their treatment programs an to provide clinicians with new ways to intervene to help them remain in treatment,” Gottlieb said.
ReSET-O has helped decrease illicit drug use while improving abstinence in patients who have opioid use disorder. Clinical trials did not show side effects from using the program and adverse events that were evaluated were a result of opioid use disorder, including cardiovascular disease, gastrointestinal diseases, HIV, Hepatitis C, nutritional diseases, risk of overdose, depression, mania, suicidal behavior and suicidal ideation and attempts.