DGAP-News Tetra Bio-Pharma Provides Update on Clinical Development Program for QIXLEEF(TM)
DGAP-News: Tetra Bio-Pharma Inc. / Key word(s): Miscellaneous
QIXLEEF(TM) 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(c) trials) then in patients with advanced cancer with inadequately controlled pain (PLENITUDE(c) trials). QIXLEEF(TM), 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.
The Company began regulatory discussions on QIXLEEF(TM) 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(TM) 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(TM) to the market as a prescription drug and seek guidance and approval on the drug development strategy.
Since the beginning of the clinical development program in late-2016, QIXLEEF(TM) 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 the safety profile, including cardiovascular, pharmacodynamics and pharmacokinetics, of smoked and vaporized QIXLEEF(TM).