Perth, Australia and Philadelphia-based Zelira Therapeutics Ltd, which develops of cannabis medicines has received the final report for its ZTL-101 medicinal cannabis trial for insomnia. Its findings suggest that ZTL-101 cannabis treatment is safe and effective for chronic insomnia, and the company says these results open prospects to launch and distribute this product in global markets including the USA in the second half of 2020.
The trial was undertaken at the world-class University of Western Australia (UWA) Centre for Sleep Science and was led by principal investigator 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 started, each participant was able to take a single (0.5 ml of 11.5 mg total cannabinoids) or double (1 ml of 23 mg total cannabinoids) their dose of the medication, delivered sublingually, according to their symptoms.
Oludare Odumosu, PhD, managing director Zelira USA, says in a release, “We are pleased with the results of the study. 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.
“We acknowledge the dedicated team at the UWA Centre for Sleep Science and we thank the patients and supporting investigators who participated in the study.”
Eastwood, a professor and director at the Centre for Sleep Science at the University of Western Australia, says, “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.”
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 quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued, and improved overall functioning.
As well as the United States, Zelira will also aim to supply its insomnia formula in other markets where medicinal cannabis has been legalized including the United States, Australia, Germany, and the UK.
These positive results add ZLT-101 to the portfolio of Zelira products being commercialized including the recently launched HOPE range, in global markets including the United States, Australia, Germany and the United Kingdom. The company is also undertaking further human clinical trials for autism and opioid reduction and is on-track to bring additional products for aged care and oral-healthcare to market later in 2020.
Osagie Imasogie, chairman of Zelira, says, “The positive outcome to this trial represents an important milestone for Zelira and its commitment to address the unmet need for clinically validated cannabis medicines and offer more treatment options to physicians and patients. Zelira’s clinically validated products, such as ZLT-101, continue to play a disruptive role in the traditional pharmaceutical industry.”