CAUMZ is a non-opioid alternative in Phase 3 development for the treatment of pain and inflammation, and Tetra are one step closer to bringing the kit to market.
CAUMZ, a cannabinoid-derived medicine using synthetic THC and CBD, is a non-opioid alternative in Phase 3 development for the treatment of pain and inflammation. The Phase 3 Serenity® trial for advanced cancer pain is currently recruiting patients at 20 clinical trial sites across the United States and Canada. Tetra Bio-Pharma Inc. continues to anticipate regulatory approval for CAUMZ by late 2020.
U.S. Food and Drug Administration (FDA) have allowed the evaluation of CAUMZ Kit as a combination drug/device product, providing clarity on regulatory approval pathway. This is a first step in the regulatory strategy to bring CAUMZ Kit to the market with additional FDA guidance anticipated by the end of 2019.
What do you know about CAUMZ?
Tetra Bio-Pharma Inc., a leader in drug discovery and development for cannabinoid-derived products and therapeutics, late last week announced the U.S. Food and Drug Administration (FDA) has determined that the company’s CAUMZ Kit can be evaluated as a combination drug/device product to be used for the treatment of pain and inflammation.
The CAUMZ Kit is comprised of two constituents: Tetra’s lead drug CAUMZ and the Mighty Medic device of Storz & Bickel, a wholly owned subsidiary of Canopy Growth.
Based on the FDA’s determination, the CAUMZ Kit has been assigned to the Center for Drug Evaluation and Research (CDER) for premarket review and further assessment.
The two constituent parts; a handheld Mighty Medic vaporiser, and two CAUMZ capsules coated with 17mg delta-9-tetrahydrocannibinol and 5mg cannabidiol are contained in a PVC/aluminium blister pack. The drug component and device component will be linked together by the labelling of each component and developed for sale as one combination unit.
The vaporiser, exclusively unique to Tetra’s drug delivery methods, is a portable, handheld, battery-powered device with an LED temperature display. Control buttons on the device set the temperature, and a removeable cooling unit with a disposable lip piece with check valve is located on top of the filling chamber.
For the drug component, CAUMZ is coated onto the surface of a dosing capsule designed for insertion into the medical device. The dosing capsules, available in blisters, are individually packaged in a sealed thermoformed tray. CAUMZ drug dosing capsules and a fully assembled Mighty Medic for vaporisation and inhalation of the generated vapor are required for therapy with CAUMZ and are provided in the CAUMZ Kit. CAUMZ drug dosing capsule blister cards will not be available without the Mighty Medic device.
“Now have a clear regulatory pathway”
Chief Executive Officer of Tetra Bio-Pharma, Guy Chamberland, PhD, said: “We are pleased to have the CAUMZ Kit viewed by the FDA as a drug/device product and now have a clear regulatory pathway through CDER for development in the U.S. Storz & Bickel/Canopy is providing the medical device component, Mighty Medic, of the combination product to be tested in the Serenity trial and to be ultimately evaluated as part of the drug approval review process.”
“This decision by the FDA is the first part of the regulatory strategy to bring the CAUMZ Kit to the market. We are fully engaged to be bringing the Mighty Medic vaporiser medical device to the market for the inhalation of prescription drugs. The Mighty Medic device was selected because it has a robust quality system that adheres to the FDA’s quality system regulations and conforms to European medical device directives.
“We look forward to working with the FDA to create the single regulatory file required for the marketing approval of the CAUMZ Kit as a drug/device combination product.”
Tetra has a co-development agreement with Canopy Growth Corporation, which originally was Storz & Bickel prior to its acquisition by Canopy. The Mighty Medic is not available in the U.S. as a medical device. This medical device will be used in the Serenity clinical trial under authorisations granted by the FDA.
Tetra Bio-Pharma Inc.
Tetra Bio-Pharma Inc. is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved and FDA reviewed clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
Tetra Bio-Pharma has 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 its mission, 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.