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Large Trial Finds Cannabis-Derived Drug Eases Chronic Low-Back Pain Without Addiction Signal

The peer-reviewed finding puts a standardized low-THC formulation on a formal approval path.

Overview

  • In a randomized, placebo-controlled study of roughly 800 adults, patients on VER-01 reported nearly a 2-point pain reduction after 12 weeks versus 1.4 points with placebo.
  • Researchers reported no signs of dose escalation, abuse, dependence or withdrawal, though side effects such as dizziness, headache, fatigue and nausea led to over 17% discontinuing early.
  • Participants who entered a six-month extension phase continued to see incremental declines in pain and reported better sleep and physical function.
  • The investigational extract contains very low, microdose levels of THC compared with consumer marijuana products, reflecting a pharmaceutical, standardized formulation.
  • Vertanical has filed for European approval and says it is working with U.S. regulators to design a study intended to support an FDA application.