Global therapeutic medicinal cannabis company, Zelira Therapeutics Ltd. has announced that it has received the final report for its medicinal cannabis trial on insomnia.
Zelira operates out of Philadelphia, Pennsylvania, and Perth, Western Australia, and works in partnership with researchers and organizations around the world, including the Complutense University in Madrid, Spain, the Telethon Kids Institute in Perth, and the Children’s Hospital of Philadelphia.
Zelira conducted the trial at partner University of Western Australia’s Centre for Sleep Science using a randomized, double-blind, crossover design to evaluate the efficacy of its ZTL-101 formulation in the treatment of chronic insomnia symptoms.
Twenty-three patient-participants diagnosed with chronic insomnia symptoms received treatment for 14 nights with ZTL-101, and 14 nights with a placebo, separated by a one-week washout period.
After the commencement of dosing, participants were able to take a sublingual single dose of 11.5mg total cannabinoids or double dose of 23mg total cannabinoids, according to their symptoms.
Zelira reports that there were no serious adverse reactions to ZTL-101, the maximal dose was well-tolerated, and non-serious adverse reactions were mild and transient, with more than 95% of them resolving by the next morning.
According to study results, participants experienced 33-65 minute improvements in time spent asleep, 10-minute reductions in wake time during the night, improvement of sleep quality, and improvement in feeling rested upon waking.
Participants also experienced statistically significant reductions in stress level and fatigue, as well as an improvement in functioning.
“The significant improvement in subjective sleep quality and feelings of waking up rested as reported by participants was particularly notable,” study Principal Investigator, Professor Peter Eastwood. “Positive patient experiences with minimal side-effects are critical to the success of any insomnia drug and highlights the potential for ZTL-101 to address a key area of unmet need. It is likely that further improvements in efficacy could be achieved by dosing over a longer period and potentially at higher doses.”
Professor Eastwood says that the study is the most rigorous clinical trial ever undertaken to assess how medicinal cannabis can treat chronic insomnia, noting that the improvements achieved by ZTL-101 were impressive given the relatively short two-week dosing window.
Zelira says that it is leading the development of clinically-validated full-spectrum cannabis medicines focus on aiding sleep, emphasizing that an estimated 70 million Americans have insomnia, and the market for prescription and over-the-counter insomnia drugs is projected to be worth more than $4 billion by 2022.
Zelira says that the trial results open prospects to release ZTL-101 around the world, including in the United States in the second half of 2020.
Zelira says that it is on track to launch in the Australian market by early Q3, 2020.