Timeless Herbal Care to commercialize CBD gel capsule developed as part of first major U.S. and international opioid study

Timeless Herbal Care, a premier Jamaican-based medical cannabis company, is pleased to announce it has been selected by Mount Sinai Hospital (New York) to participate in a ground-breaking clinical trial dedicated to evaluating the therapeutic effects and potential of cannabinoids for the treatment of opioid use disorder. Led by renowned global researcher Dr. Yasmine Hurd, the trial is to develop a novel and safe, efficacious non-opioid and non-addictive, FDA approved, cannabidiol (“CBD”) based treatment to address the severe epidemic of opioid addiction through anti-anxiety intervention. In 2017, the Dept. of Health and Human Services declared the U.S. Opioid Use epidemic a public health emergency, with studies showing 2.1 million people had an opioid use disorder, while another 11.4 million people misused prescription opioids. 

The clinical trial will be led by renowned principal researcher, Dr. Yasmin L. Hurd, PhD, the Ward-Coleman Chair of Translational Neuroscience at the Icahn School of Medicine at Mount Sinai, New York City, and Director of the Center for Addictive Disorders for the Mount Sinai Behavioral Health System. This trial will be the largest U.S. and first international large-scale, multi-site clinical trial that will include up to 540 patients spanning the United States, Canada, Australia, Europe, and Jamaica.

Under the direction of Mt. Sinai, Timeless will serve as a co-sponsor of this clinical trial with MediPharm Labs, a leader in specialized, research-driven cannabis extraction and cannabinoid isolation. Timeless will provide its proprietary formulations, Intellectual Property, and industry know-how, while MediPharm Labs will be the exclusive manufacturer of a proprietary hemp-derived CBD capsule. Timeless and Medipharm Labs will have joint ownership in the Intellectual Property developed during the clinical trials.

Timeless will lead international commercialization efforts for any products resulting from positive outcomes of this historic study.

“This agreement is significant for Timeless and countless others who live with daily pain to finally be able to begin the clinical research required,” said Courtney Betty, Founder and CEO of Timeless Herbal Care. “Timeless is inspired by the commonality of the vision between Medipharm and Mount Sinai with the commitment of our joint teams to execute. This achievement is also a recognition of the tremendous work of the Timeless team, both internally and externally.”

“This collaboration with MediPharm Labs and Timeless lays the foundation for groundbreaking research in developing safe and efficacious CBD products” said Dr. Yasmin Hurd. Dr. Hurd continued, “The vast number of lives lost, societal burdens and marked health toll caused by opioid addiction continues to grow worldwide and requires bold and unique actions to curb this tidal wave of the opioid epidemic. This consortium strategy is founded on results from established clinical trials that now give us an important opportunity to further advance scientific research in large populations. This is a critical path for the development of true CBD medicinal products that meet FDA approval to treat opioid addiction.”

“We are very excited to collaborate with Dr. Hurd and Mt. Sinai to drive the CBD conversation forward with this study,” said Marques Colston, Chief Business Development Officer, Timeless Herbal Care and former Superbowl Champion with the New Orleans Saints. “The promise of CBD as a pharmaceutical-grade alternative to opioids can potentially help millions who are searching for pain management alternatives, including professional athletes and sports leagues like the NFL, NBA, and others.”

The arrangement remains subject to Timeless Herbal Care, Mount Sinai and MediPharm Labs entering into a clinical trial agreement, MediPharm Labs and Timeless Herbal entering into a separate intellectual property agreement and certain regulatory approvals.

Phase II and Phase III trials will be conducted in two stages and will be a randomized, double-blinded, placebo-controlled study in which at least 500 participants will be studied in different stages. The study will also include a multisite evaluation that will gather evidence of the safety and efficacy of CBD in opioid reduction through anti-anxiety intervention in patients around the world.

Dr. Yasmin Hurd: “The opioid epidemic of overdose death is worldwide. Current medications are opioid based which bear enormous governmental regulation, particularly due to the addictive nature of the substances, and significant societal stigma. Non-intoxicating, non-opioid medications are critical to curb the opioid epidemic and related disorders. CBD has been shown in pre-clinical and small clinical trials to reduce drug-induced craving and anxiety in patients with an opioid use disorder.”

Founded in 2014 by visionary Courtney Betty, Timeless Herbal Care is Jamaica’s premier medical cannabis company built on science-based natural cultivation, superior extraction techniques, and industry partnerships including long-term, inclusive relationships with local communities and small farmers. With the first GMP certified facility in Jamaica, the next stage of development is focused on large-scale growing and extraction of premium products for global export. Timeless is also one of the most influential regulatory leaders in the world and continues to bring the best practices learned in Jamaica to the world as others look to develop new medical cannabis programs and policies.

Founded in 2015, MediPharm Labs has the distinction of being the first company in Canada to become a licensed producer for cannabis oil production under the ACMPR without first receiving a cannabis cultivation license. This expert focus on cannabis concentrates begins in its purpose-built laboratory designed to incorporate cGMP (current Good Manufacturing Practices) workflow and ISO standard-built clean rooms and critical environments, allowing MediPharm Labs to produce purified, pharmaceutical-like cannabis oil and concentrates for advanced derivative products. MediPharm Labs has invested in an expert, research-driven team, state-of-the-art technology, downstream extraction methodologies and purpose-built facilities to deliver pure, safe and precisely-dosed cannabis products to patients and consumers. MediPharm Labs’ private label program is a high margin business for the company, whereby it opportunistically procures dry cannabis flower and trim from its numerous product supply partners, to produce cannabis oil concentrate products for resale globally on a private label basis.