pp-051.1 Tablets, immediate release (IR)
Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
For moderate to severe acute pain, including post-surgical pain.
Phase 3 global development, Small-molecule analgesic;
Dual NOP/MOP receptor agonist (nociceptin and µ-opioid receptors). This first-in-class mechanism provides potent analgesia while potentially lowering risks associated with traditional opioids.
Route / form: Oral immediate-release (IR) tablet.
Differentiation: Provides opioid-level analgesia with a differentiated dual-receptor mechanism that may reduce respiratory depression, abuse potential, and other opioid-related safety concerns. Suitable for both acute pain and chronic pain programs.
Manufacturer #18873
A privately-held, mid-size biopharma firm focused on developing and marketing therapies for ADHD, pain, addiction and CNS disorders. It combines proprietary drug-delivery technology with global development and licensing efforts to deliver patient-friendly medications worldwide.
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