US FDA CBD Approvals Set to Soar

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Sophia Ononye outlines the history of cannabis as a medicine in the US and, following the first FDA approval of a cannabis-derived drug product in 2018, the highly promising landscape for further approvals.

 

The landscape for approved CBD products is highly promising and will undoubtedly lead to additional FDA approvals for the management of several diseases

It is fairly well established that cannabis, which is also known as marijuana, and cannabis-derived products can be potentially used for the effective management of a number of medical conditions, such as AIDS wasting syndrome, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea. Moreover, natural products have found diverse applications as antimicrobial, antifungal, and anticancer agents as well as in the treatment of neurological disorders. In fact, the medical benefits of the cinchona tree and quinine, which are still used today for appetite stimulation and malaria respectively, were published as early as 1794 per PubMed data. Although there has been a prominent shift towards the development of large molecules, such as biologics and antibody-drug conjugates, natural products remain a fundamental core of medicinal chemistry

 

The use of cannabis for pain management is well documented and in light of the ongoing opioid crisis, many biopharmaceutical companies are exploring innovative ways to utilize has spurred widespread interest because of the ongoing opioid crisis. Yet, despite its considerable potential, the US Food and Drug Administration (FDA) has only approved one cannabis-derived and three cannabis-related drug products mainly due to variability in patient response and abuse potential.

 

In 1985, the FDA approved Marinol®, an oral form of dronabinol that is indicated for the treatment of anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS) and as an alternative therapy for the management of nausea and vomiting associated with cancer chemotherapy in patients with inadequate response to conventional antiemetic treatments. In 2017, the FDA approved Syndros®, which is a liquid formulation of dronabinol with the same indications as Marinol but under a different schedule (class II) due to the potential for Syndros abuse via inhalation. Cesamet®, generically known as Nabilone, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.

 

Dronabinol is a light yellow, sticky resinous oil formulated in sesame oil that was created to mimic tetrahydrocannabinol (THC), which is the primary psychoactive component of cannabis. In 2006, the FDA approved Cesamet, which contains the active ingredient nabilone, for the management of nausea and vomiting associated with cancer chemotherapy in patients with inadequate response to conventional antiemetic treatments. Nabilone is synthetically derived with a chemical structure similar to THC and is considered a class II controlled substance because of its high potential for abuse.

 

In 2018, the FDA approved the first prescription pharmaceutical formulation of highly purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the “high” associated with marijuana, and the first in a novel category of anti-epileptic drugs (AEDs). Hence, it comes as not surprise that many biotech investors increased their investment stake in several emerging CBD stocks surging the stock prices and increasing conversations about the benefits of medical cannabis.

 

Yet it took another 20 years following the Marinol approval for the FDA to ease the regulatory requirements for biopharmaceutical companies to conduct research on CBD. There are several reasons for the FDA’s skepticism such as the psychomotor effects associated with cannabis used, dose variability issues, delayed onset and short duration of effects. In addition, the potential for abuse is an obvious concern for the FDA. From a manufacturer’s perspective, development of cannabis is usually stalled by challenges such as hydrophobicity, insolubility and poor bioavailability. Yet the landmark approval of Epidiolex has paved the way for additional indications beyond pain management.

 

Taken together, the landscape for approved CBD products is highly promising and will undoubtedly lead to additional FDA approvals for the management of several diseases, including glioblastomas, autism spectrum disorders and multiple sclerosis spasticity. Moreover, as more states continue to step in to legalize and regulate the recreational use of cannabis, the stigma surrounding its use will decline and allow for increased receptivity and innovation in its use for medicinal purposes.

 

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