CAUMZ™, a cannabinoid-derived medicine that uses synthetic THC and CBD delivered to patients using an inhaler called theMighty Medic, a medical device created byStorz & Bickell, a wholly-owned subsidiary of Canopy Growth. The device is currently approved for use in Canada and is under review by theU.S. Food and Drug Administration(FDA) as part of the approval process for CAUMZ™.
CAUMZ™ is being investigated for two indications. Our Phase II/III clinical trial called SERENITY©will study CAUMZ™ as a treatment to improve physical functioning and for modulating cachexia progression in patients with advanced cancer. Cancer cachexia remains an unmet medical need even though an estimated 50-80% of cancer patients suffer from it.
A further Phase II trial called REBORN© is a head to head study investigating the efficacy of CAUMZ™ versus immediate-release oral opioids to measure pain intensity and the onset of action for breakthrough pain in cancer patients. For individuals suffering from debilitating pain, the faster they can achieve relief the better, so if successful, this research may offer an improved quality of life for these patients and reduce their opioid consumption. We are optimistic that CAUMZ is qualified for several FDA regulatory pathways that would see the time needed to have the drug approved and to market considerably reduced.
Another of Tetra’s cannabinoid-derived drugs undergoing Phase II clinical trial (the ‘Plenitude’ study; NCT04042545) in the United States is QIXLEEF™, an inhaled medicine that is being tested for the treatment of uncontrolled pain in advanced cancer patients. Unlike CAUMZ™ which is based on a synthetic cannabinoid, QIXLEEF™ is a botanical product that uses dried flower buds. A Letter of Advice and Type B meeting with the U.S. Food and Drug Administration (FDA) added important information that will evaluate the drugs’ impact on advanced cancer patients with uncontrolled pain. Based on a successful outcome, Tetra would be able to commercialize the world’s very first dried flower botanical cannabinoid drug product for the treatment of uncontrolled pain in patients with advanced cancer.