Cannabinoids in pharmaceutical development

The development of cannabinoids in the pharmaceutical industry has exploded over the past few years. With the gradual liberation of regulations worldwide that govern cannabis and its pharmaceutical derivatives for medicinal use, this week PharmaCompass leveraged its Technology Prospector tool to develop a map of the global development landscape of these drugs.

MORE INFORMATION ON EXCIPIENTS FOR CANNABINOIDS IN THE CPHI SPECIAL

Technology Prospector is a proprietary Pharmacompass technology. We scanned patents and journal publications, over the past five years, for cannabinoid-related content to identify the organizations which are developing products linked to the technology of interest.

Over the past two decades, there has been a resurgence of patient interest in using cannabis and cannabinoids to treat a variety of conditions, including chronic pain, cancer pain, depression, sleep disturbances and neurological disorders. This increased interest has resulted in a renewed scientific focus on the medical use of substances found in the cannabis plant, namely cannabinoids.

The two most extensively studied ingredients in cannabis are tetrahydrocannabinol (THC) and cannabidiol (CBD). However, it is estimated that over 100 other cannabinoids and terpenoids in cannabis may also have medical uses.

THC is known to produce the psychoactive effects sought by recreational users, such as euphoria, relaxation and heightened sensory experiences. There is also evidence to support the medical use of THC in controlling nausea and vomiting, stimulating appetite and reducing pain. CBD, on the other hand, may moderate the psychoactive effects of THC, while also reducing epileptic seizures.

In the early 1990s, a cannabinoid system in the human brain and body was discovered that was responsible for the control of important biological functions, such as cognition, memory, pain, sleep and immune functioning.

In view of this increased interest in cannabinoids, we are leveraging PharmaCompass’ Technology Prospector to provide an overview of the organizations actively involved in developing products linked to cannabinoids.

Cannabinoid products on market

Several cannabinoid-containing medicinal products have been on the market for many years. Dronabinol (brand name: Marinol), a synthetic form of THC, got approved in 1985 for prevention of nausea and vomiting during chemotherapy and hauled in over US$ 100 million in annual sales. After the initial launch, the product also got approval for appetite and weight loss in patients with HIV/AIDS. In 1998, the product got reclassified from a Schedule II drug to a Schedule III drug by the Drug Enforcement Administration (DEA) in the US.

In order to prevent drug abuse, the DEA has divided these substances into five categories (or Schedules) based on each drug’s (1) potential for abuse, (2) safety, (3) addictive potential and (4) whether or not it has any legitimate medical applications. The potential for drug abuse is the highest for Schedule I drugs and lowest for Schedule V drugs.

MORE INFORMATION ON EXCIPIENTS FOR CANNABINOIDS IN THE CPHI SPECIAL

Nabilone (brand names: Cesamet and Canemes) is a synthetic cannabinoid similar to THC. The main indication for its use is nausea and vomiting associated with chemotherapy, usually after previous treatments have failed.

GW Pharmaceuticals’ Sativex, a mixture of equal quantities of THC and CBD from two cannabis extracts, is approved for sales in countries for the treatment of spasticity (muscle spasms and stiffness) related to multiple sclerosis — a disease that affects 1.3 million people worldwide, of which up to 80 percent suffer from spasticity.

In 2018, the US Food and Drug Administration (FDA) approved GW Pharmaceuticals’ Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome. The drug can be taken by patients aged two years and above.

The battle of synthetic versus natural Cannabinoids

In order to win approval for Epidiolex, GW Pharmaceuticals set up giant greenhouses in the United Kingdom where it raises cannabis plants under highly controlled conditions. The plants are then made to undergo extraction and purification to crystallize pure CBD at GW’s facilities.

There are other firms which are supporting production of cannabinoids via organic synthesis rather than extraction from the cannabis plant. There are already multiple Drug Master Files (DMF) submissions to the FDA for synthetic cannabidiol, as companies bet that the future of cannabinoid production will be from organic chemistry.

Firms like Noramco and Johnson Matthey, which have conventionally been active in producing controlled substances from opium like morphine, codeine etc, have focused significant resources … continue on pharmacompass

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