An Australian medical cannabis company is trumpeting the results of a clinical trial for its insomnia treatment.

Zelira Therapeutics said last week that it received the final report for its proprietary cannabis formulation known as ZTL-101, and that its findings “represent a world-first clinical” validation of the treatment as being safe and effective in combating chronic insomnia.

Those findings, Zelira said, “open prospects to launch and distribute this product in global markets including the USA in the second half of 2020.”

Zelira said the trial was conducted at the University of Western Australia (UWA) Centre for Sleep Science, where researchers used a randomized, double-blind, cross-over design to evaluate ZTL-101’s effectiveness.

“Twenty three patients were treated for 14 nights with ZTL-101 and 14 nights with placebo, separated by a one-week washout period,” Zelira said in a press release. “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.”

Promising First Results

According to Zelira, the analysis “showed treated patients slept significantly longer, went to sleep faster and went back to sleep sooner after waking,” while those same patients “also reported significant improvement in quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.”

Peter Eastwood, the principal researcher in the trial and a professor at the University of Western Australia Centre for Sleep Science, called it “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,” Eastwood said in a statement. 

Zelira has headquarters in both Perth and Philadelphia.

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