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.