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SRP-001 is a novel, first-in-class, non-opioid analgesic and antipyretic developed by South Rampart Pharma. It is an acetaminophen analog designed to provide effective pain relief without the addiction risk of opioids or the liver and kidney toxicity associated with acetaminophen and NSAIDs. Its mechanism centers on inducing high levels of N-arachidonoylphenolamine (AM404) in the midbrain’s periaqueductal grey (PAG) region, which activates TRPV1 receptors and modulates endocannabinoid signaling pathways involved in pain processing. This action also influences cannabinoid receptor 1 (CB1), fatty acid amide hydrolase (FAAH), prostaglandin signaling, and other genes related to mechanical nociception. Unlike paracetamol/acetaminophen, it does not generate hepatotoxic metabolites such as NAPQI. Phase 1 clinical trials have demonstrated that SRP-001 is safe, well-tolerated, non-hepatotoxic, with robust pharmacokinetics including a half-life up to 10 hours. The drug has received FDA Fast Track designation for acute pain and is being advanced into Phase 2 trials for acute pain, neuropathic pain, chronic pain conditions including migraine[1][2][3][4][5][6].
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