Mitragyna, CBD and Kava Near Green Light for Phase 3 Trial
A match made in botanical heaven? Hot on the heels of an impending federal ban on mitragyna speciosa, on the basis that the plant and it’s constituents are dangerous and have no medical benefit or application, Health Advance, Inc. announces their agreement with Micro Medtech, Ltd. For North American licensing rights to cebidiofen and polyoxyfen, two new patent-pending formulations combining ibuprofen and a botanical extract blend utilizing kratom, cbd and kava root.
These two firms will work hand in hand with Nutrasource Diagnostics, a health claims expert charged with performing the due diligence review, assist in product development and determine medical claims. The formulas would be considered GRAS (generally recognized as safe) by the FDA if the results are favorable.
Six to eight weeks of product development process is estimated beginning in March. The combination of cannabis derived CBD and mitragyna speciosa (kratom) sourced polyoxyfen will be subjected to clinical studies in order to meet the stringent regulatory, clinical and manufacturing prerequisites for FDA clearance and product release.
This breaking news is exciting for more than one reason. For kratom advocates seeking more hard data concerning kratom’s potential medicinal benefits as well as for the fact that this would be one of the first “pharmaceutical food” product to make it to “phase three” clinical trials (the final stage before FDA clearance for it’s sale as a drug or supplement and/or any claims of benefits).
Kratom and CBD research a possible cash-cow
Kratom for a moment broke through to some bit of positive press in Fall of 2014 at the time that Sigma-Aldrich was developing kratom based alkaloidal solutions. After German pharma giant Merck acquired Sigma, the development seemed to be at a standstill but with the introduction of polyoxyfen (the first pharmaceutical food product from kratom to be offered a credible medical study on it’s possible medicinal properties and application.
Following possibly in the footsteps of GW Pharmaceuticals, developers of Sativex, the first plant-derived cannabidiol medication. Sativex is available in 29 countries, if Health Advance can pass GRAS regulatory standards in US and Canada then Health Advance could have the first pharmaceutical product derived from cannabis (or kratom for that matter) to pass FDA muster.