Zelira Therapeutics Ltd (OTCQB: ZLDAF) has received the final report for its ZTL-101 medicinal cannabis trial for insomnia. Its findings represent a world-first clinical validation demonstrating that ZTL-101 cannabis treatment is safe and effective for chronic insomnia. Dr. Oludare Odumosu, Managing Director Zelira USA said, “This trial has yielded a comprehensive data-pack that supports our plans to launch the world’s first clinically validated cannabinoid-based insomnia medicine into global markets this year.”
The company said in a statement that the trial was undertaken at the University of Western Australia Centre for Sleep Science and was led by principal investigator Professor Peter Eastwood, and used a randomized, double-blind, cross-over design to evaluate the efficacy of Zelira’s proprietary cannabis formulation (ZTL-101) to treat patients diagnosed with chronic insomnia. Twenty three patients were treated for 14 nights with ZTL-101 and 14 nights with placebo, separated by a one-week washout period. After dosing commenced, each participant was able to take a single (0.5ml of 11.5mg total cannabinoids) or double (1 ml of 23mg total cannabinoids) their dose of the medication, delivered sublingually, according to their symptoms.
The analysis showed treated patients slept significantly longer, went to sleep faster and went back to sleep sooner after waking. Patients also reported significant improvement in the quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.
Professor Peter Eastwood, Principal Investigator for the study, and Director at the Centre for Sleep Science at the University of Western Australia said, “This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia. The fact that ZLT-101 treatment achieved statistically significant, dose-responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short two-week dosing window.”
Zelira noted that an estimated 70 million Americans have insomnia and that the market for prescription and over-the-counter medications is forecast to be worth over $4 billion in annual revenue by 2022. Insomnia affects -30% of the US population and is a major risk factor for patients suffering from chronic pain, neurological disorders (Parkinson’s, dementia), mental disorders (anxiety, depression, anorexia) and cardiovascular disease.
Zelira said it will seek to supply its clinically validated insomnia formula in countries and states where medicinal cannabis has been legalized including Australia, the USA, Germany, and the United Kingdom. The company remains on track to launch in the Australian market by early Q3, 2020. The company is also evaluating undertaking further clinical development of ZTL-101 in order to achieve its goal of product registration in Australia.