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Focus on Nutraceuticals & Natural Products: Medical Use of Cannabis
Posted on July 5th, 2017 by Dr. Makarand Jawadekar, Ph.D in Pharma R&D
These days, there is a lot of focus on nutraceuticals and ‘natural products’, derived from nature or alternately synthesized as ‘nature-identical compounds’ and used in nutraceuticals products.
Many of the FDA-approved (about one third) products are derived from natural (plant/animal) sources. However, most of these pharmaceutical products are synthesized in a way which makes a task easier for quality assurance reasons, as well as for retaining batch-to-batch consistency. This allows one to have a reference standard, where a pure drug can be identified and verified every time a batch is manufactured.
The way I am defining pharmaceutical product is one that needs to go through characterization of the active ingredient, do an exhaustive pre-clinical testing in multiple animal species to ensure animal safety as well as see efficacy in lab animals. Additionally, it means conducting a variety of testing to develop ADME, pharmacokinetic and pharmacodynamics studies. This also includes understanding mechanism of action of the drug to understand basic pharmacology of the compound. After having done all the pre-clinical work, then one needs to file an IND (Investigational New Drug) Application to the FDA. When a clinical investigation focuses on an endpoint involving the cure, mitigation, prevention, treatment or diagnosis of disease, the IND process for the pharmaceutical R&D comes into play.
However, the way nutraceuticals or natural products are defined, when the product contains a single or multiple active ingredients, the focus of the study is solely on the function of the human body and no disease endpoint is implied or the endpoint falls within the scope of a ‘healthy claim’ or ‘medical food’, and then the IND requirements defined above do not come into play. The regulatory requirements for nutraceuticals are around purity and quality. There are no medical ‘cure’ or ‘endpoint’ claims or labeling claims that are expected to be included in the package. One can only say that the capsule or a tablet “supports” or is useful for maintaining a healthy condition.
Now with a recent focus on cannabis and its potential use for medical purposes, there are already many potential cannabis-based drugs in the pharma pipeline at various stages of development. Christopher Cunningham & Missy Lowery just published a review article in AAPS Magazine (June 2017 issue), where they have provided a detailed table, which summarizes the current drugs undergoing the regulatory approval process: Marinol, Sativex and Syntros for various AIDS-associated conditions and MS plasticity.
According to them, there are five products undergoing clinical trials. These are Epidiolex (CBD, oral solution), Insys Pharma CBD oral solution for Dravet Syndrome, CBD Gel for Epilepsy, CBD Gum (Can Chew) for IBS and CBDV extract for focal seizures. In addition to these in clinical studies, they have also listed four compounds in pre-clinical development, namely for neuropathic pain, intra ocular pressure, ulcerative colitis and traumatic brain injury. These are all in the pharma R&D project pipeline.
Of course, there are nutraceutical companies working on some of the naturally-derived Cannabinoid actives, where application of novel drug delivery paths would allow better compliance and better controlled release action for the patient’s convenience. These companies will obviously have an alternate path for progression, supposedly quicker than the pharmaceutical R&D path. Before they proceed, they will need a clear policy guidance from state and federal legislative branches.
In early March 2017, Jay Syrmopoulos published the following post and explained the current status (in italics below):
In an effort to push back against repressive federal control of marijuana policy, bipartisan legislation was introduced in Congress by representatives Tom Garrett (R-VA) and Tulsi Gabbard (D-HI) to exclude cannabis from the federal Controlled Substances Act (CSA), which absurdly lists marijuana as a Schedule 1 substance — a classification that denotes a substance being dangerous and having no known medicinal value.
Passage of this legislation would provide states with the exclusive authority to regulate marijuana how they see fit – without the ominous threat of federal criminalization. In a prepared statement, Rep. Garrett explained that states are “more than capable” of deciding what policies best benefit their own citizens – without the need for federal oversight. If passed, this bill would take marijuana off the federal controlled substances list – joining other industries such as alcohol and tobacco. Passage of the “Ending Marijuana Prohibition Act of 2017” would remove cannabis from the CSA so that it would no longer be listed as a substance regulated by federal law. This bipartisan legislation would empower states to establish their own marijuana regulations, which would allow for more flexibility in creating policy.
Let us see where this legislative process leads us to. There are for sure obvious medical benefits that everyone sees and it all depends upon how the federal government and states collaborate on these regulations so that the patient gets the real value from cannabis, which was not possible in the past, due to its inclusion in CSA.
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All opinions shared in this post are the author’s own.
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Dr. Makarand Jawadekar, Ph.D
Independent Pharma Professional
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