Pear Therapeutics announced today that reSET-O, a digital therapeutic for opioid use disorder, has received an Expedited Access Pathway (EAP) designation from the FDA. The EAP designation doesn't mean that the FDA has cleared the product, only that it has committed to fast-tracking it through the clearance process because of its timely public health value.
“The opioid epidemic continues to ravage cities and towns across this country with officials estimating even higher numbers of overdoses in 2017,” Dr. Corey McCann, president and CEO of Pear Therapeutics, said in a statement. “With states struggling to provide treatment resources, we firmly believe that prescription digital therapeutics will change the way we address opioid dependence. We applaud the FDA for recognizing the need to bring innovative new treatment options to patients and clinicians and we look forward to closely working with them under the EAP program to accelerate access to reSET-O.”
Boston- and San Francisco-based Pear Therapeutics received a de novo FDA clearance just last month for reSET, a 12-week program designed to treat addiction and dependency on stimulants, cannabis, cocaine, and alcohol — but not opioids. Interventions and assessment tools are provided to the patient via a mobile app, and the data collected is delivered to a clinician dashboard.
reSET-O is a similar therapeutic aimed at treating opioid use disorder specifically. It's designed to be used in combination with buprenorphine opioid replacement therapy, since the standard of care for opioid addiction involves both medications and behavioral interventions.
The EAP program was announced in 2014 and expanded in 2016, with the passage of the 21st Century Cures Act, to include 510(k)-subject devices. Unlike other programs such as the FDA's Emergency Use Authorization (EUA), which was granted earlier this year to Nanobiosym's Zika Virus test, an EAP doesn't allow a device to be used like a clearance would. Instead, it signals a commitment by the FDA to move through the clearance process as quickly as possible without compromising the process.
"Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA's PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting De Novo requests, or any other standards of valid scientific evidence," the agency writes on its website. "Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager. The extent to which the FDA provides these features depends on the availability of resources."
The FDA encourages use of the EAP for "medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions."
Pear Therapeutics is also one of the pilot participants in the FDA's new precertification program, which will likely provide the company with yet another way to fast-track its digital therapeutics to market.CULTURE KINGS PARRAMATTA IS NOW HERE!