Chronic Pain Phase II study

Objectives:

This open label Phase II dose-ranging study is being conducted to demonstrate the safety and tolerability of oral administration of Cybis 10:25 oil in patients with moderate

to severe chronic back or neck pain unresponsive to over-the- counter (OTC) analgesics.

The study also investigates the dose-response relationship of Cybis 10:25 oil in terms of pain relief and quality of life outcomes in this patient population and examines the

pharmacokinetics of Cybis 10:25 oil after single and repeat doses.

Methods:

Twenty-four patients with moderate to severe chronic back and neck pain unresponsive to OTC analgesics will enter the four-week dosing period.

Doses of Cybis 10:25 oil will increase weekly in all patients from 0.5 mL once daily to 0.5 mL twice daily, 1.0 mL twice daily, and 1.5 mL twice daily, as tolerated.

Patients are assessed at the end of each one-week dose period for safety and tolerability with a physical examination and recording of adverse effects.

Pain response, depression / anxiety / stress, sleep quality, and overall treatment satisfaction are also assessed at the end of each dose period using validated assessment tools.

Pharmacokinetic analyses are undertaken after the first dose, and after the last dose at each dose level.

The results of the study will demonstrate the safety of Cybis 10:25 oil in this population and provide information on the dose response relationship of Cybis 10:25 oil to support dose selection and calculation of patient numbers for a pivotal Phase III randomised controlled trial to be commenced in 2023

Results:

See our results here –