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Tetra Bio-Pharma Provides Update on Clinical Development Program for QIXLEEF™
Tetra Bio-Pharma Provides Update on Clinical Development Program for QIXLEEF™.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n\n\n\nTetra Bio-Pharma Provides Update on Clinical Development Program for QIXLEEF™\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 Provides Update on Clinical Development Program for QIXLEEF™\nPR Newswire\nOTTAWA, ON, Oct. 14, 2021\n\n\n\nOTTAWA, ON, Oct. 14, 2021 /PRNewswire/ - Tetra Bio-Pharma Inc. (\"Tetra\" or the \"Company\") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today provided an update on the progress and significant achievements of its lead investigational drug, QIXLEEF™. \nQIXLEEF™ is a botanical inhaled drug product with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The drug will be first indicated in patients with cancer suffering of uncontrolled breakthrough pain (REBORN© trials) then in patients with advanced cancer with inadequately controlled pain (PLENITUDE© trials). QIXLEEF™, with its innovative and proprietary dosing data, provides fast acting relief from pain, offering patients a viable, safer, and non-opioid option for pain management.\nThe Company began regulatory discussions on QIXLEEF™ with both the U.S. Food and Drug Administration (FDA) and Health Canada in mid-2016.  This included obtaining a product jurisdiction decision for the regulation of QIXLEEF™ as a drug-device combination product.  This type of decision is binding and defines the regulatory path to marketing approval for a combination product.  Pre-Investigational New Drug (pre-IND or Type B meetings) and pre-Clinical Trial Application type meetings were held with the regulators to discuss the regulatory requirements to bring QIXLEEF™ to the market as a prescription drug and seek guidance and approval on the drug development strategy.  \nSince the beginning of the clinical development program in late-2016, QIXLEEF™ strictly adhered to and complied with the regulatory requirements of a prescription drug. The Company completed two Phase 1 clinical trials in healthy volunteers to assess ...