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Pain Brake

Development stage: Preclinical
Lead developer: GT Biopharma
Modality: Small Molecules
Administration: Oral

Overview

**Pain Brake** is a non-opioid analgesic drug candidate developed by Georgetown Translational Pharmaceuticals (GTP) for chronic neuropathic pain, utilizing a novel dose fractionation approach with AccuBreak tablets to deliver frequent small accurate doses, avoiding peak dose side effects while achieving nearly complete pain relief. It leverages a 505(b)(2) regulatory pathway, requiring only two Phase I studies in healthy volunteers for NDA submission, with an anticipated filing 15-18 months from funding at a budget of ~$2.6 million. The active component does not induce tolerance, dependence, or abuse potential, and an orphan drug application is planned for a specific responsive disease.[2][8]

Other names: PainBrake

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