South Rampart Pharma Receives FDA Fast Track Designation
NEW ORLEANS – South Rampart Pharma, a clinical-stage biopharmaceutical company targeting the safer treatment of pain, has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company for SRP-001 for the treatment of acute pain. SRP-001 is a “non-opioid analgesic that activates pain signaling pathways in the midbrain’s periaqueductal grey region without liver and kidney toxicities,” said a South Rampart Pharma spokesperson.
The Fast Track designation facilitates the development and expedites the review of new therapies for serious conditions, aiming to bring important new drugs to patients earlier and address unmet medical needs.
“Despite the ongoing opioid crisis and limitations of existing pain medications, including acetaminophen as the leading cause of acute liver failure in the U.S. and other parts of the western world, innovation in the pain space remains surprisingly stagnant,” said Hernan Bazan, co-founder of South Rampart Pharma. “Today’s acknowledgment by the FDA of the critical need for innovative medications in acute pain perfectly matches our unwavering commitment to expedite its clinical development and bring this transformative therapy to market as swiftly as possible.”
In Aug. 2023, South Rampart announced that the first patient of its Phase 1 trial , a multiple ascending dose study, had been dosed. The primary objective of the MAD study is to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of oral SRP-001 in healthy male and female volunteers, with the primary endpoints being safety and tolerability by assessing adverse events, vital signs, electrocardiograms, physical examinations, laboratory safety tests and select PK/PD parameters. The trial is expected to be completed in Q4 2023.
“In the CNS and pain space, Fast Track designation for SRP-001 isn’t just a regulatory milestone; it’s a commercial accelerant. This designation recognizes the scientific innovation behind SRP-001 and potential market impact as a safer, more effective alternative to opioids and acetaminophen,” said Neil Singla, chief scientific officer at Lotus Clinical Research.