Bio-pharmaceutical company Zelda Therapeutics (ASX: ZLD) has taken a decisive step towards mitigating the effects of the growing opioid epidemic that is gripping several Western countries including Australia and the US.
Earlier today, Zelda announced that its phase 1 opioid reduction trial was formally approved by the St Vincent’s Hospital Ethics and Governance Committees. The news means Zelda can now assess the effectiveness of medicinal cannabis in reducing opioid dependence in patients with chronic non-cancer pain.
The phase 1 trial is expected to commence “immediately”, and to be jointly undertaken with St Vincent’s Hospital in Melbourne, Australia. Preliminary results are due by the end of August this year with final results expected sometime in Q4 2019.
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.
In addition, the trial will have secondary outcomes including pharmacokinetics and the effects on pain, mood, sleep and possibly most importantly, opioid use.
Assuming the first phase is a success, its outcomes will form a subsequent larger scale phase 2 study that will assess the impact of oral whole plant extract on patients’ ability to tolerate a “stepped opioid tapering protocol” which Zelda hopes will achieve its goal of alleviating opiate dependence.
Opioids have become an existential problem for public healthcare systems globally with more than 130 people falling prey to opioid overdoses in the US every day.
Statistics show that an estimated 49,000 people died from opioid overdose in 2017.
The misuse of opioids such as prescription pain relievers, heroin, and synthetic opioids such as fentanyl has become a “national crisis” according to the US National Institute on Drug Abuse.
The issue puts intense pressure on public health care systems, to the point of costing the US $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.
Prescription opioids treating chronic pain are linked to serious side effects including physical dependence, which is an acknowledged growing global crisis.
The root cause of the opioid epidemic hails back to the 1990s when pharmaceutical companies reassured the medical community that patients would not become addicted to prescription medications.
As a result of scientifically-backed acceptance, healthcare providers rushed to prescribe them at greater rates, which subsequently led to chronic misuse of opioids, before it became clear that such medications could indeed be highly addictive.
“To our knowledge, this is the first clinical trial to be designed with a primary endpoint assessing the efficacy of a full spectrum plant-derived cannabis formulation containing THC and CBD to reduce opioid dependence in chronic non-cancer patients,” said Dr Richard Hopkins, managing director of Zelda Therapeutics.
“If successful, the outcome of these trials will likely have an immediate impact in major global markets where opioid overuse and addiction is a major problem,” said Mr Hopkins.