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Tetra Bio-Pharma Receives EMA Orphan Drug Designation for a Novel Topical Therapeutic Containing CBD
Tetra Bio-Pharma Receives EMA Orphan Drug Designation for a Novel Topical Therapeutic Containing CBD.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n\n\n\nTetra Bio-Pharma Receives EMA Orphan Drug Designation for a Novel Topical Therapeutic Containing CBD\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nTetra Bio-Pharma Receives EMA Orphan Drug Designation for a Novel Topical Therapeutic Containing CBD\nCanada NewsWire\nOTTAWA, ON, May 18, 2022\n\n\n\nNovel proprietary cannabidiol (CBD) therapeutic has been classified as an orphan medicinal product for the indication of epidermolysis bullosa (EB).Drug is ready for human clinical trials.OTTAWA, ON, May 18, 2022 /CNW/ - Tetra Bio-Pharma Inc. (\"Tetra\" or the \"Company\") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today announced that the European Medicines Agency (EMA) has classified PPP004 as an orphan medicinal product for the treatment for epidermolysis bullosa (EB). The designation represents PPP004's third orphan drug designation (ODD) as a treatment for EB.\n\n \n \n \n \n \n \n\n \n\"This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB\", said Dr. Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma.  \nAbout PPP004PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The base product is a proprietary pharmaceutical-grade formulation composed of Active Pharmaceutical Ingredients (APIs) that are manufactured as per Good Manufacturing Practices (GMP) requirements, and excipients classified as GRAS (generally regarded as safe). The cream will be packaged in a metered-dose, airless pump system, designed to deliver a measured dose of API consistently per actuation and to protect the APIs from known sources of degradation, namely light and oxygen. PPP004 was developed to help manage pain and itch in patients with EB and promote wound healing.\nPPP004 containing CBD only has been granted ODD by both the U.S. FDA and the EMA for treatm...