Editor: What To Know
- The goal of STeP is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA's mission to protect and promote public health.
- Pear Therapeutics Pear-010 is a PDT candidate intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain.
- Pear Therapeutics advises the Safer Technologies Program (STeP) is a voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics.
Pear Therapeutics, Inc. (Nasdaq: PEAR), the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced it has received Safer Technologies Program (STeP) for Medical Devices designation from the U.S. Food and Drug Administration (FDA) for Pear-010, a product candidate designed for the treatment of acute and chronic pain.
Pear Therapeutics Pear-010 is a PDT candidate intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. The product candidate is designed to reduce acute postoperative and postprocedural pain and analgesic (e.g., opioid) use related postoperative urinary retention, postoperative ileus, or postoperative unintended advancing sedation and respiratory depression.
With more than 50 million patients in the U.S. suffering from pain, it is among the most common and costly acute as well as chronic conditions, estimated to drive as much as $635 billion in annual health care expenditures, disability and loss of productivity.1,2 The over-reliance on opioid-based therapies has led to significant adverse events and a nationwide epidemic of opioid misuse and diversion.3-6 Effective pain management is an important factor in reducing length of hospital stay and improving outcomes for medical and surgical patients, including their risk for hospital readmission.7-11
“We believe pain is well suited for treatment with a PDT because currently more than 50 million patients are left to choose between pain and treatment by opioids,” said Yuri Maricich, Pear’s Chief Medical Officer. “We applaud FDA for recognizing the need to help patients gain more timely access to treatments for conditions like pain.”
Pear intends to utilize its PearCreate™ platform to develop Pear-010. PearCreate is the company’s discovery and development platform.
Pear Therapeutics advises the Safer Technologies Program (STeP) is a voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics. The goal of STeP is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health. STeP participation does not imply product authorization. Pear-010 has not received marketing authorization from FDA and it is not available for sale in the United States.
