The FDA has officially cleared reSET-O — a digital therapeutic to treat opioid use disorder (OUD) jointly developed by Pear Therapeutics and Sandoz, a division of Novartis — a little over a year after it was granted an Expedited Access Pathway designation from the agency.
This announcement makes reSET-O the first digital therapeutic to treat patients with OUD. Patients will need a valid prescription from their licensed provider in order to access the therapeutic. The therapeutic employs cognitive behavioral therapy (CBT) to help outpatients living with OUD. reSET-O is intended to be used by patients who are currently under the supervision of a clinician along with other outpatient treatments including medication-assisted-treatment, such as transmuscosal bupernorphine.
The system consists of a 12-week interval program, which gives user interactive therapy lessons. Patients can participate in behavioral and skill-building therapy through text, audio and videos.
Why it matters
As the opioid overdoes morality rate continues to sore in the US, many are looking to alternatives to traditional care for treating the epidemic. Technology in particular has been one avenue that many companies are looking towards.
Meanwhile, the healthcare industry has been increasingly talking about new ways to treat patients through digital medications. This clearance has implications for both the treatment of opioids and the continuation of digital therapeutics into mainstream medicine.
"Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,"Corey McCann, president and CEO of Pear Therapeutics, said in a statement. "There is an urgent need for new and innovative therapeutics to address this public health epidemic. This groundbreaking decision by the FDA ushers in a new standard for treating patients with Opioid Use Disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy."
The company said the technology is already working in clinical trials. A clinical trial done by the National Institute on Drug Abuse found that patients who used reSET-O in addition to their clinical interactions and buprenorphine had a significant reduction in treatment dropout as opposed to patients who received the standard of care.
This is Pear’s second digital therapeutic to be FDA cleared. The first, reSET, was granted a de novo clearance in 2017. reSET focuses on treating substance abuse and was the first software-only digital therapeutic the FDA has cleared with claims to improve clinical outcomes in a disease.
reSET-O has been in the works for sometime. In October of 2017 the technology was grated an Expedited Access Pathway designation, which fast-tracked it through the FDA process because of its timely public health value.
Pear has a history of working closely with the FDA. In the fall of 2017 it was selected as one of the companies to participate in the FDA’s Pre-Cert program, which focus on the quality of the firm or developer rather than the individual product. If the FDA is satisfied that the firm is responsible and safe in its development, then it won't need to regulate each product from that firm.
Down the road Pear is looking to use digital therapeutics beyond addiction treatment. In March, it inked a deal with Novartis to work together to develop two digital therapeutics for multiple sclerosis and schizophrenia.
On the record
“Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way,” said Richard Francis, CEO, Sandoz. “New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes. At Sandoz, we are proud to be a joint pioneer in this exciting new field.”