About Cannabidiol

Cannabidiol (CBD) is a naturally occurring molecule in hemp plants that possesses tremendous therapeutic potential.

Currently, that therapeutic potential has been proven in a single FDA-approved product for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC). However, with the passing of the Agriculture Improvement Act of 2018, which removed hemp from the definition of marijuana in the Controlled Substances Act (CSA), there has been an explosion of unapproved products containing CBD claiming the ability to treat a wide range of medical conditions and potentially putting the health and safety of consumers at risk.

These products sold at retail locations do not undergo the rigorous testing that FDA-approved pharmaceutical products do, and little is known about the amounts of CBD and other cannabinoids they contain, or the occurrence of toxic elements including pesticides, chemical contaminants, and adulterants.

The reason most often reported for taking these unapproved products is pain management. And while there is a wealth of anecdotal evidence regarding the use of CBD to manage pain, there have been no major clinical studies to demonstrate that CBD as a monotherapy can effectively control pain.

What is known about CBD is that it has a low bioavailability if orally ingested, meaning high doses are required to achieve therapeutic effects, and it can possess serious safety concerns including liver toxicity.

The RITe™ Platform is uniquely positioned to maximize the potential of CBD and may reduce its most serious safety concerns, due to the RITe™ Platform’s superior absorption and ability to avoid first-pass metabolism.

This landscape has driven our decision to systematically collect data on the safety and efficacy of CBD through partnerships with leading independent research institutions. The proliferation of unapproved CBD products and dramatic increase in consumer interest has created an urgency to better understand this molecule and the FDA’s authority to regulate the use of CBD remains unchanged.

We are committed to investigating the potential of CBD utilizing the RITe™ Platform in accordance with FDA regulations and guidelines.

For more information on the FDA’s activities related to CBD, please see their website.

For more information on the development of ORAVEXX™ please check back for frequent updates.

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