The Letter is with respect to Tetra’s botanical cannabinoid-derived drug, QIXLEEF. This is the second Letter that the FDA has provided to the company. The first, on January 26, 2017, provided “in-depth guidance” to Tetra on the development of QIXLEEF.
The new Letter provides addition guidance on the clinical and safety progress of QIXLEEF. It also “lays out the requirements for marketing approval (i.e., approved for sale) for cancer and non-cancer pain indications.”
Dr. Guy Chamberland, CEO and Chief Regulatory Officer for Tetra Bio-Pharma commented on the Letter.
“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.
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.”
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.”
The Letter pertains to QIXLEEF’s use as “a second- or third-line drug for use in pain relief” (advanced pain relief). Examples of advanced pain relief drugs include opioids.
A report from Allied Market Research pegged the global market for pain management at $60 billion in 2016, projected to rise to $130 billion by 2023. Opioid use (and abuse) is a major component of these rising revenues.
These dangerous drugs are responsible for over 40,000 deaths per year in the United States from overdoses alone. Cannabis is already a proven substitute for opioids in pain relief.
An FDA-approved licensed and approved botanical cannabinoid drug would have tremendous potential to claim market share here. This is because of the extremely benign safety and tolerance profile for cannabinoid-based drugs.
TBP is up 2.38% today (as of this writing) to CAD$0.43. This is well below Tetra’s 52-week high of CAD$1.20.