Tetra Bio-Pharma Receives Favorable Letter of Advice from USA FDA for QIXLEEF
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. Chamberland added, “With this letter we are confident that we can develop QIXLEEF for pain indications beyond cancer. Indeed, QIXLEEF can be developed all the way to an indication for use as a second- or third-line drug for use in pain relief. Tetra will be continuing to develop QIXLEEF for advanced cancer pain but will now evaluate the best market opportunity within this large potential multi-billion dollar market of second- or third line pain medications. If clinical trials are successful, this will significantly shift the opioid battle.”
Pain Management Drugs Market by Drug Class (NSAIDs, Anesthetics, Anticonvulsants, Antimigraine Agents, Antidepressants, Opioids [Tramadol, Hydrocodone, Oxycodone, and Others], and Nonnarcotic Analgesics) and Indication (Arthritic Pain, Neuropathic Pain, Cancer Pain, Chronic Back Pain, Postoperative Pain, Migraine, and Fibromyalgia) – Global Opportunity Analysis and Industry Forecast, 2017-2023
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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