Friday, October 13, 2023
South Rampart Pharma, Inc., a clinical-stage biopharmaceutical company focused on developing safer pain treatments, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for SRP-001. This innovative non-opioid analgesic is designed to address acute pain by activating pain signaling pathways in the periaqueductal grey (PAG) region of the midbrain without causing liver and kidney toxicity. The FDA's Fast Track designation is a significant regulatory milestone aimed at accelerating the development and review of new therapies for serious conditions, ultimately bringing critical drugs to patients sooner to address unmet medical needs.
The Fast Track designation offers several key benefits:
More frequent meetings and written communication with the FDA for discussions about the clinical development plan and trial design to ensure the collection of necessary data to support drug approval.
Eligibility for Accelerated Approval or Priority Review if specific criteria are met.
Rolling Review, which allows the company to submit completed sections of its New Drug Application (NDA) for review, rather than waiting for the entire NDA to be finalized.
South Rampart Pharma, emphasized the urgent need for innovative medications in the acute pain space, especially given the opioid crisis and the limitations of existing pain medications. He expressed the company's commitment to expediting the clinical development of SRP-001 and bringing this potentially transformative therapy to market as quickly as possible.
Lotus Clinical Research, highlighted the significance of Fast Track designation for SRP-001, not just from a regulatory perspective but as a potential catalyst for commercial success. He emphasized the scientific innovation behind SRP-001 and its potential to serve as a safer and more effective alternative to opioids and acetaminophen in the CNS and pain treatment space.
In August 2023, South Rampart initiated its Phase 1 trial (NCT05484414), a multiple ascending dose (MAD) study, with the dosing of the first patient. The primary objectives of the MAD study include evaluating the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of oral SRP-001 in healthy male and female volunteers. Key endpoints focus on safety and tolerability, assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations, laboratory safety tests, and select PK/PD parameters. The trial is expected to conclude in Q4 2023.