The FDA has granted a fast track designation to the BRTX-100 (BioRestorative Therapies) program for the treatment of chronic lumbar disc disease.
The designation “underscores high unmet need for a therapeutic alternative to opioids and surgical interventions,” according to a company press release.
The FDA decision was based on positive preliminary phase 2 safety and efficacy data reported to date, and could lead to a priority review designation and Accelerated Biologics License