Opioids crisis needs Tetra TETRA’S WEEK IS NO TURKEY – WITH GREEN LIGHT FROM THE FDA AND ITS IMPLICATION FOR THE OPIOID CRISIS
November 29, 2019
Guy Chamberland
CEO and Chief Regulatory Officer, Tetra BioPharma Inc.
The announcement this week that the US Food and Drug Administration (FDA) authorized Tetra to move ahead with PLENITUDE© trial for our investigational drug QIXLEEF™ (PPP001) had me stop and think about what this really means. Of course, it positively affected our stock price, but at the end of the day its significance is way more far-reaching.
Naturally all of us at Tetra were extremely excited and why not? We now have two unique products in development for the American market. QIXLEEF™ (PPP001) our original botanical drug and CAUMZ™ a synthetic cannabinoid-derived product will both be studied for the treatment of uncontrolled pain in individuals with advanced cancer.
Why would a company develop two drugs for the same indication? The answer is as simple as the ability to offer patients and physicians effective cannabinoid-derived therapeutic options based on their preference for either a natural plant-based product or a synthetic drug. The scary alternative for these patients is to resort to opioids to alleviate their relentless pain.
Choice of treatment is vitally important, but there is another side of the research that I believe deserves notice, and another good reason to be excited. One of PLENITUDE’s © critical endpoints is to document opioid consumption. If we can demonstrate a reduction in opioid use with QIXLEEF™ (PPP001) then finding a solution to the opioid crisis may be attainable. Such a finding would be significant.
Opioid addiction has reached epidemic proportion. Data from the US Centers of Disease Control and Prevention cited that more than 72,000 Americans died of drug overdoses in 2017, up nearly from 2016 https://www.cnn.com/2018/08/16/health/us-overdose-death-report-cdc/index.html. The actual numbers may be higher according to the CDC because investigations may be incomplete. In addition, nearly 30,000 overdose deaths were related to fentanyl and other synthetic opioids in 2017, which is 22 times the number of deaths due to these drugs in 2002, according to the CDC. There is no disputing the enormity of this public health issue.
I am certain we can all agree that this week’s news holds out hope for those suffering from unrelenting pain, as well as for their families. The ability to advance our research with equal vigour for both QIXLEEF™ and CAUMZ™ brings Tetra and medical science that much closer to addressing an unmet medical need. With American Thanksgiving taking place this week, this Canadian believes there is a lot to be thankful for.