SOUTH RAMPART PHARMA, INC.


Associated tags: Pharmacokinetics, Pain, Hepatotoxicity, Liver, Nonsteroidal anti-inflammatory drug, PAG, Paracetamol, Kidney, Female, Priority review, Vital signs, Safety, NDA, FDA, New Drug Application, Accelerated approval (FDA), PK, Pharmaceutical industry, Male, Plasma protein binding, Volunteering, White Light Rock & Roll Review, MAD, Fast Track

Locations: LOUISIANA

South Rampart Pharma Expands Global Patent Portfolio with EU Approval for FDA Fast-Tracked SRP-001 for Pain

Retrieved on: 
Wednesday, November 1, 2023
Female, FDA, White Light Rock & Roll Review, Aes, Patent, Neuropathic pain, Wireless ambulatory ECG, U.S. Patent No. 1, Fast Track, Liver, MAD, Kidney, EPO, Volunteering, Priority review, Male, NSAIDS, Unified Patent Court, European Patent Office, PK, Accelerated approval (FDA), New Drug Application, Pain, Liver failure, Nonsteroidal anti-inflammatory drug, OBI Pharma, Inc., NDA, Fast track (FDA), Safety, Vital signs, Paracetamol, European Patent Convention, Plasma protein binding, Pharmaceutical industry, EU

NEW ORLEANS, Nov. 1, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage life science company focused on developing innovative pain treatments, announced today the issuance of European Patent No. 3672938 by the European Patent Office (EPO) effective November 1, 2023. This patent will apply to all Unified Patent Court-participating and non-participating European Unitary member states.

Key Points: 
  • This patent will apply to all Unified Patent Court-participating and non-participating European Unitary member states.
  • This patent, excluding possible patent term extensions, is expected to provide South Rampart with market exclusivity in the EPO member states until 2038, aligning with the U.S. Patent No.
  • On October 4, 2023, the U.S. FDA granted Fast Track designation to SRP-001 for acute pain.
  • The FDA Fast Track designation allows for more frequent interactions with the FDA, streamlining the clinical development plan and trial design to expedite drug approval.

South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain

Retrieved on: 
Thursday, October 12, 2023
Pain, Male, Priority review, Food, Female, Plasma protein binding, PAG, U.S. FDA, MD, Aes, Communication, Liver, PK, Safety, Western world, MAD, Vital signs, Paracetamol, FDA, White Light Rock & Roll Review, Collection, Accelerated approval (FDA), Kidney, NDA, Acute liver failure, Automated ECG interpretation, Fast Track, New Drug Application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Volunteering, CNS, Patient, Pharmaceutical industry, Medical device

NEW ORLEANS, Oct. 12, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage biopharmaceutical company targeting the safer treatment of pain, today 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 novel, first-in-class non-opioid analgesic that activates pain signaling pathways in the midbrain's periaqueductal grey (PAG) region without liver and kidney toxicities. 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.

Key Points: 
  • The Fast Track designation accelerates SRP-001's path to U.S. FDA submission for the treatment of acute pain
    Enhanced time-to-market delivers a therapeutic alternative to habit-forming opioids and acetaminophen, the leading cause of acute liver failure in the U.S.
    NEW ORLEANS, Oct. 12, 2023 /PRNewswire/ -- South Rampart Pharma, Inc. ("South Rampart" or the "Company"), a clinical-stage biopharmaceutical company targeting the safer treatment of pain, today 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 novel, first-in-class non-opioid analgesic that activates pain signaling pathways in the midbrain's periaqueductal grey (PAG) region without liver and kidney toxicities.
  • 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.
  • "In the CNS and pain space, Fast Track designation for SRP-001 isn't just a regulatory milestone; it's a commercial accelerant.