Zelda Therapeutics Ltd (ASX: ZLD, OTCQB: ZLDAF) announced that its Phase I Opioid Reduction Trial has been formally approved by the St Vincent's Hospital Ethics and Governance Committees.
The trial's primary end-point is to assess the effectiveness of medicinal cannabis in reducing opioid dependence in patients with chronic non-cancer pain.
- The trial at St Vincent's Hospital Melbourne will begin immediately with final results expected by Q4 2019.
- It will be the first clinical trial designed with a primary end-point assessing the efficacy of cannabis in reducing opioid dependence.
- Outcomes will feed into larger Phase II trial.
The Phase I trial will evaluate the safety and tolerability of whole plant extract following single and repeated doses in nine patients with chronic non-cancer pain on long-term opioid analgesia.
Secondary outcomes include pharmacokinetics and the effects on pain, mood, sleep and opioid use over the duration of the trail.
The Phase I trial will commence immediately with preliminary results expected by late Q3 2019 and final results in Q4 2019. The outcomes from the Phase I trial will inform a subsequent larger scale Phase II study that will assess the impact of oral whole plant extract on patient ability to tolerate a stepped opioid tapering protocol.
Prescription opioids treating chronic pain are linked to serious side effects including physical dependence, which is an acknowledged growing global crisis. In the United States an estimated 49,000 people died from opioid overdose in 2017.
Zelda's Managing Director, Dr Richard Hopkins, commented, "we're delighted to have the trial formally underway."
"To our knowledge, this is the first clinical trial to be designed with a primary end-point assessing the efficacy of a full spectrum plant-derived cannabis formulation containing THC and CBD to reduce opioid dependence in chronic non-cancer patients."
"If successful, the outcome of these trials will likely have immediate impact in
major global markets where opioid overuse and addiction is a major problem."
The trial will be undertaken jointly with the prestigious St Vincent's Hospital