MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a pharmaceutical company specialized in cannabis, is pleased to announce that the Company’s research partner McMaster University (the “Researcher”) has received a no objection letter from Health Canada to proceed with research with MediPharm Labs CBD50 and CBD10:2. This is a key milestone in moving forward with the Company’s strategy to be the go-to cannabis partner for pharmaceuticals containing cannabis.

This phase 2 trial is a pilot, double-blind, randomized, placebo-controlled trial that will be evaluating the efficacy and safety of a cannabis-oil for the treatment of insomnia in major depressive disorder. The study is being conducted by a clinical research group led by Dr. Benicio Frey, Professor, McMaster University and Psychiatrist, St. Joseph’s Healthcare Hamilton. As North America has made progress in diagnosing and eliminating the stigma around mental health, more patients are looking for therapeutic treatment options.

The Researchers believe that cannabidiol (“CBD”) with or without THC could be effective in the treatment of sleep disorders related to depression. In order to prove this efficacy, a high quality, dosable and standardize formulation is needed for clinical trial material. MediPharm Labs will use its Cannabis Drug Licence and Drug Establishment Licence to provide access to clinical trial material that meets these pharmaceutical quality standards and Good Manufacturing Practices (“GMP”), as well as provide investigative protocol and regulatory approval support.

“As a pharmaceutical company specialized in cannabis, MediPharm Labs is encouraged by the ongoing research and development of drugs containing cannabis. This study will create opportunities to show efficacy in our already commercialized cannabis oil while also making progress on our long-term goal to manufacture pharmaceutical drugs containing cannabinoids as an active ingredient,” said Keith Strachan, President and Interim CEO, MediPharm Labs.

“Many individuals around the world are using cannabinoids to treat their sleep problems without robust clinical evidence from placebo-controlled trials. This study is, therefore, a major step towards evidence-based research investigating the efficacy and safety of CBD and CBD/THC in the treatment of insomnia in those who suffer from depression,” said Dr. Benicio Frey.

The is the second approval of its kind for a clinical trial with McMaster. A trial lead by a separate clinician group received a letter of no objection in June 2021 to proceed with using MediPharm Labs CBD50 for a randomized trial studying the effect of cannabidiol vs. placebo on persistent post-surgical pain following total knee arthroplasty.

The Company looks forward to progressing both these active trials with the respective researchers while using its GMP Drug Establishment License and Health Canada Cannabis Drug License to supply API and finished goods to others development pharmaceutical drugs with marketing authorization.