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.