FDA STeP Designation for Pear Pain Product

FDA has granted a Safer Technologies Program (STeP) designation to Pear Therapeutics for its Pear-010 product candidate intended to treat acute and chronic pain. The company says the product is intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients age 18 and older with acute postoperative and acute postprocedural pain. Pear-010 is designed to reduce acute postoperative and postprocedural pain and analgesic use-related postoperative urinary retention, postoperative ileus, or postoperative unintended advancing sedation and respiratory depression, the company says.

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 therapeutics. The STeP goal is to expedite device development, assessment, and review while preserving the legal standards for 510(k) clearance.