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Tetra Bio-Pharma Receives Favorable Letter of Advice from USA FDA for QIXLEEF
Tetra Bio-Pharma Receives Favorable Letter of Advice from USA FDA for QIXLEEF.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n FDA Feedback continues to support the development of QIXLEEF for second- or third-line therapy for adult patients with uncontrolled pain FDA advice consistent with previous feedback paving the way for the marketing approval of QIXLEEF OTTAWA, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced that it has received a favorable Letter of Advice from the US Food and Drug Administration for QIXLEEF. “We are extremely excited to have received this letter from the FDA for QIXLEEF.  Once again, it demonstrates the FDA’s commitment to approve this botanical drug for chronic pain if the quality, non-clinical safety and human clinical data are positive.  This Letter of Advice clearly shows that QIXLEEF can be developed for chronic pain conditions beyond pain in patients with advanced cancer.  It also reconfirms FDA’s previous position on the development and commercialization of QIXLEEF for pain management including indications, such as second- or third-line therapy for uncontrolled cancer and non-cancer pain,\" said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma.  On January 26, 2017, FDA had previously provided in-depth guidance to Tetra on the development of QIXLEEF (PPP001).  This Letter of Advice provides Tetra new guidance based on our clinical and safety progress with the quality of QIXLEEF and lays out the requirements for marketing approval (i.e., approved for sale) for cancer and non-cancer pain indications.  \"FDA collaboration has been excellent and continues to show that Tetra develops prescription drugs in accordance with FDA regulatory standards, in place for pharmaceutical products,\" commented Dr. Chamberland. According to Allied Market Research (reference), the global drug market for pain management was about $60 billion in 2016 and is estimated to reach $130 billion by 2023.  This includes pain medications for indications such as Arthritic Pain, Neuropathic Pain, Cancer Pain, Chronic Back Pain, Postoperative Pain, Migraine, and Fibromyalgia. First line pain medications include acetaminophen and NSAIDs whereas second- and third-line drugs include Lyrica, Cymbalta and opioids. ...