The U.S. Food and Drug Administration on Monday cleared Pear Therapeutics’ mobile application to help increase retention of patients undergoing outpatient treatment for opioid abuse.
The reSET-O app is a prescription cognitive behavioural therapy intended to be used in addition to other treatments under the supervision of a health care professional, the FDA said.
More than 72,000 Americans died from drug overdose last year, including illicit drugs and prescription opioids, with President Donald Trump declaring the opioid addiction crisis a public health emergency.
The FDA has taken a number of steps to speed up the process of approving alternative options to contain the abuse.
The agency recently chose eight medical device makers, including a virtual reality startup, from an innovation contest aimed at tackling the crisis.
Pear’s app can be downloaded directly to a patient’s phone after they receive a prescription to do so from their doctor, the FDA said.
“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,” FDA Commissioner Scott Gottlieb said.
Novartis AG unit Sandoz will lead the roll out of the app in the United States in the fourth quarter.
The FDA had permitted marketing of Pear’s app to help treat substance use disorders in 2017, making it the first mobile medical app used in tackling drug and alcohol abuse.