Zelira Therapeutics Ltd ZLDAF ZLD announced its medicinal cannabis trial to treat insomnia has met its objectives.
The company said it has received the final report for the trial, which indicates its formulation — dubbed ZTL-101 — has produced “statistically significant and dose-responsive improvements” in Insomnia Severity Index scores compared to the placebo.
Zelira is now able to expand its portfolio this year by launching the world’s first clinically validated medicinal cannabis product for insomnia.
“Zelira will continue to deploy its unique ‘launch, learn and develop strategy to launch more scientifically validated products, targeting various conditions, into the market in 2020,” Imasogie said. “Zelira’s clinically validated products, such as ZLT-101, continue to play a disruptive role in the traditional pharmaceutical industry.”
Zelira said it will launch in countries where medicinal cannabis has been legalized including parts of the United States, Germany, the United Kingdom and Australia. The company is anticipating its launch in the Australian market early in the third quarter of 2020.
Some 23 patients took part in the trial, which was held at the University of Western Australia’s Center for Sleep Science. Each participant was treated for 14 nights ZTL-101 and 14 nights with a placebo, separated by one week.
ISI Scores decreased between 26% and 36%. Measures making up the score include total sleep, awake times during the night, the time taken to fall asleep, quality of sleep and the feeling of being rested after sleep.
Zelira also stated the treatment shown to have “significantly improved” subjective measures of stress, fatigue, and social functioning.
UWA Centre for Sleep Science director and principal investigator of the study, Professor Peter Eastwood said the study represented the “most rigorous clinical trial ever undertaken” to assess the therapeutic potential of medicinal cannabis to treat chronic insomnia symptoms.
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