South Rampart Pharma has received US Food and Drug Administration (FDA) fast track designation for SRP-001 to treat acute pain.
A non-opioid analgesic, SRP-001 stimulates pain-signalling pathways in the periaqueductal grey region of the midbrain without causing toxicities in the liver and kidneys.
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The latest development will aid the company in expediting the development of SRP-001 to a regulatory filing.
With the granting of fast track status, the company can hold regular meetings and written communication with the regulator on clinical development and trial design, and seek accelerated approval or priority review from the FDA.
South Rampart Pharma dosed the first subject in a Phase I multiple ascending dose (MAD) clinical trial of SRP-001 in August 2023.
The trial is designed to assess the safety, tolerability and pharmacokinetics/ pharmacodynamics (PK/PD) of oral SRP-001 in healthy subjects.
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By GlobalDataThe primary endpoints of safety and tolerability will be analysed based on adverse events, vitals and electrocardiograms, among other outputs.
The company expects to conclude the trial in the fourth quarter of 2023.
South Rampart Pharma CEO and co-founder Hernan Bazan stated: “Despite the ongoing opioid crisis and limitations of existing pain medications, including acetaminophen as the leading cause of acute liver failure in the US and other parts of the Western world, innovation in the pain space remains surprisingly stagnant.
“The 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 potentially transformative therapy to market as swiftly as possible.”
