Insomnia Archives - Green Market Report

Adam JacksonAugust 2, 2022

Zelira Therapeutics Ltd (ASX: ZLD,OTC-QB: ZLDAF), recieved formal approval from German regulatory authority BfArM to launch in the German medical cannabis market for its new insomnia medication Zenivol.

Zenivol is the first clinically validated, pharmaceutical-grade, cannabis-based sleep medication. Zenivol’s clinical research achieved the highest level of scientific review when it was peer reviewed in the Journal of Sleep — available by prescription in Australia under the country’s legal cannabis regulations.

“The formal approval of Zenivol by BfArM in Germany marks a major milestone for Zelira,” said Zelira CEO Dr. Oludare Odumosu. “Germany is one of the largest global markets for cannabinoid-based medicines, and also one of the highest quality global regulatory markets for pharmaceuticals. We look forward to working with our partner, Adjupharm, in launching Zenivol in Germany and supporting patients and physicians in treating chronic insomnia in a safe and effective manner. With formal regulatory approval for Zenivol now received in Germany, we continue to progress activities to license Zenivol into other global markets.”

Zelira is a leading global therapeutic medical cannabinoid company with access to the world’s largest and fastest-growing cannabinoid medicine markets. The company owns a portfolio of proprietary revenue-generating products and a pipeline of candidates undergoing clinical development that are positioned to enter global markets.

The company is focused on developing branded cannabinoid-based medicines for the treatment of a variety of medical conditions in its Rx business, including insomnia, autism and chronic non-cancer pain.

The company has two proprietary formulations under the HOPE brand that are generating revenues in Australia, and Pennsylvania and have been licensed in Louisiana and Washington D.C. — with other states in the U.S. expected to follow. Zelira is also generating revenue in Australia from its proprietary and patented Zenivol, which had successfully completed the world’s first Phase 1b clinical trial for chronic insomnia where it was found to be a safe and effective treatment.

The company conducts its work in partnership with world-leading researchers and organizations including Curtin University in Perth, Western Australia; the Telethon Kids Institute in Perth; the University of Western Australia, in Perth; St. Vincent’s Hospital in Melbourne, Australia; and the Children’s Hospital of Philadelphia (CHOP) in the United States.

Debra BorchardtApril 9, 2020

Zelira Therapeutics Ltd (OTCQB: ZLDAF) has received the final report for its ZTL-101 medicinal cannabis trial for insomnia. Its findings represent a world-first clinical validation demonstrating that ZTL-101 cannabis treatment is safe and effective for chronic insomnia. Dr. Oludare Odumosu, Managing Director Zelira USA said, “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.”

Study Trial

The company said in a statement that the trial was undertaken at the University of Western Australia Centre for Sleep Science and was led by principal investigator Professor 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 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.

The 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 the quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.

Professor Peter Eastwood, Principal Investigator for the study, and Director at the Centre for Sleep Science at the University of Western Australia said, “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.”

Patient Population

Zelira noted that an estimated 70 million Americans have insomnia and that the market for prescription and over-the-counter medications is forecast to be worth over $4 billion in annual revenue by 2022. Insomnia affects -30% of the US population and is a major risk factor for patients suffering from chronic pain, neurological disorders (Parkinson’s, dementia), mental disorders (anxiety, depression, anorexia) and cardiovascular disease.

Next Steps

Zelira said it will seek to supply its clinically validated insomnia formula in countries and states where medicinal cannabis has been legalized including Australia, the USA, Germany, and the United Kingdom. The company remains on track to launch in the Australian market by early Q3, 2020. The company is also evaluating undertaking further clinical development of ZTL-101 in order to achieve its goal of product registration in Australia.