Zenivol™ launches in Australia after TGA adds to Special Access Scheme

Zelira steps into Australia to help those who suffer from Chronic Insomnia after a clinical trial boasts significant improvements.

Zelira Therapeutics Ltd (ASX: ZLD) is pleased to announce that its proprietary cannabinoid medicine Zenivol™ can now be prescribed to patients in Australia through the Therapeutic Goods Administration's (TGA) Special Access Scheme and via Authorised Prescribers. Zenivol™ is available for immediate supply via Zelira's national distribution partner Health House.

Zelira recently successfully completed a world-first; a clinical trial powered to show statistical significance through a randomised, double-blind, cross-over designed Phase 2A clinical study in patients suffering from chronic insomnia treated with Zenivol™. The results confirmed that Zenivol™ is a safe and effective therapy for chronic insomnia.

Zenivol™ treatment significantly improved key insomnia symptoms, as measured using the Insomnia Severity Index (ISI) – a current standard for measuring effectiveness of insomnia treatment, and was not associated with any serious adverse events. This trial was conducted at the world-class University of Western Australia (UWA) Centre for Sleep Science.

Analysis of secondary endpoints showed patients treated with Zenivol™ slept longer, went to sleep faster and went back to sleep sooner after waking. Patients also reported statistically significant improvements in quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.

Zelira is delighted to launch Zenivol™ in the Australian market as a leading clinically-validated cannabinoid-based treatment for chronic insomnia. Dr Richard Hopkins, Managing Director

Dr Hopkins went on to say "Zenivol™ is custom designed to address the large unmet need for insomnia patients that have failed current medications and are looking for a safe and effective alternative. The ability to support Zenivol™ with clinical trial data provides a key point of differentiation in the market and further supports our global Zelira commercialisation strategy."

"Zelira's ability to launch Zenivol ™ just five months after completing a clinical trial highlights the speed we can bring products to market using our unique 'Launch Learn and Develop' strategy. I would like to acknowledge the fantastic efforts of the Zelira team and our collaborators from the University of Western Australia who conducted the clinical trial, all of whom have made this launch possible."

For the latest news and updates on Zelira Therapeutics click here

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Mark Page
Mark Page

Mark is a UK born investing enthusiast based in Sydney. He has a keen eye for technical analysis and is paying close attention to the ongoing legalisation of cannabis for the health benefits, opportunities, and emergent industries that will follow.

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