Columbia Care Inc. has collaborated with IPS Specials, an experienced compounding pharmaceutical manufacturer, importer and distributor of unlicensed specials and licensed medicines in the UK and the rest of the EU, and Grow Biotech, a company bridging the gap between existing cannabis medicines and accepted pharmaceutical standards, to import Columbia Care's proprietary, broad-spectrum high- cannabidiol (CBD) BeneCeed tablets as a potential investigational medicinal product (IMP) to the United Kingdom (UK) for clinical study. Pending approval by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), BeneCeed would be examined in a late-stage Phase 2b clinical trial and, to the Company's knowledge, become the first botanical cannabinoid IMP approved for import from the US and the first product from Columbia Care's proprietary portfolio of cannabis-based products to be studied in randomized clinical trials.
BeneCeed, Columbia Care's proprietary, long lasting, broad- spectrum CBD 200mg hard pressed tablets, are currently being manufactured under Good Manufacturing Practice (GMP) conditions in the US. The Company's collaboration with IPS Specials and Grow Biotech enables it to import both BeneCeed tablets as an IMP as well as corresponding placebo tablets for clinical studies. Before the initiation of clinical studies using an IMP, the MHRA first requires submission and acceptance of an Investigational Medicinal Product Dossier (IMPD). IMPD development for BeneCeed is currently underway.
For years Columbia Care has been working to set the standard in the cannabis industry by building a portfolio of proprietary, precisely formulated, pharmaceutical- quality cannabis-based medicines that patients can rely on to safely and efficiently address their unmet medical needs. With the initiation of the first placebo-controlled clinical trial examining one of our proprietary cannabis- based medicines in a major underserved behavioral health population, I am proud that we are now raising the bar once more with our funding and independent research partners as we move closer to reaching this momentous milestone for our Company, said Rosemary Mazanet, M.D., Ph.D., chief scientific officer of Columbia Care. We are delighted to work with IPS Specials, which has nearly two decades of experience facilitating the import of IMPs, and Grow
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