Japanese Arm of British Drugs Company GW Pharmaceuticals Gears Up for Clinical Trial of CBD Medicine for Epilepsy

The Japanese division of British drugs manufacturer GW Pharmaceuticals is preparing to launch clinical trials into a medicinal drug containing the non-psychotropic cannabinoid cannabidiol (CBD). Despite the fact that this cannabis-derived substance has not been legalized for medicinal use in Japan, global awareness of the cannabinoid's remedial qualities has thrust it into the forefront of pharmaceutical discussion across the sea-surrounded country.

Currently, the Cannabis Control Law of Japan—otherwise known as 1948 Law No. 124—forbids the possession of cannabis and the use of cannabis for medicinal purposes. Nonetheless, progress is being made in revising the existing law. The Health, Labor, and Welfare Ministry is seeking to amend the legal framework so patients can swiftly receive cannabis-based treatment once it is approved across Japan.

CBD has been shown to harbor anticonvulsant properties, as proven in a 2010 study published in the Journal of Pharmacology and Experimental Therapeutics. With that being said, the cannabinoid may present epileptic patients with relief from seizures, minus the "high" that its psychoactive cousin tetrahydrocannabinol (THC) produces.

As many as 10,000-20,000 patients could benefit from receiving the medicine in Japan - which is home to 125.7 million people. In other countries where GW Pharma's, the product is marketed under the name 'Epidiolex.' It is designed to ease the symptoms of intractable epilepsy among patients who are non-responsive to alternative over-the-counter medications.

Should the soon-to-be-trialed cannabis medicine gain approval, it could emerge as the first-ever therapeutic cannabis-derived drug to be broadly marketed across the island country. The medicine already bagged approval in the United States in 2018 and Europe in 2019, thus reinforcing faith in Japanese lawmakers who are currently pondering the potential benefits cannabis could bring to the country's medical (and economic) landscape.

What Will Japan's CBD Trial Entail?

The forthcoming trial will see patients aged 1-65 participate. Each study subject will have been diagnosed with three kinds of intractable epilepsy, one of which is Dravet Syndrome. Over four months, the trial will require 84 patients to consume the oral medication daily at approximately 20 unique medical institutions.

Trained staff will record the frequency of epileptic seizures and side effects if any. Patients must continue taking medicine for 12 months to ensure its safety. The outlook is promising, with a previous overseas study revealing that the drug effectively minimized seizures by almost 40% in recipients.

"It will help expand treatment options for patients with intractable epilepsy," said the professor of neurosurgery at St. Marianna University School of Medicine, Ichiro Takumi, as she discussed the importance of the looming clinical trials in Japan with reporters.

Following an influx of calls from epileptic patients and families with intractable epilepsy, the health ministry approved the tests in March 2019. The Japanese government's push to support the medicine also prompted the ministry to give the tests the green light.

Despite the favorable prospects for trial, concerns have arisen regarding the safety of cannabis. Cannabis is still considered a "gateway drug" that can influence people to use more dangerous drugs, including stimulants. However, the Drug Policy Alliance debunked the gateway drug theory.

To avoid cannabis abuse problems, the Japanese government must bolster its efforts to raise awareness of cannabis' potentially harmful side effects while enlightening people about its medicinal properties.

About British Pharmaceutics Company GW Pharmaceuticals

British pharmaceutics company GW Pharmaceuticals is best known for producing globally-renowned multiple sclerosis treatment products called nabiximols. It was the first natural cannabis plant-derived product to gain market approval in any country.

The subsidiary of Jazz Pharmaceuticals is a biopharmaceutical giant specializing in the discovery, development, and commercialization of novel therapeutics from its proprietary plant-derived cannabinoid product platform.

In addition to nabiximols, GW Pharmaceuticals presents patients with Sativex, formulated to relieve the symptoms of multiple sclerosis-related spasticities. Another product featured in the company's portfolio is Epidiolex, which has been touted as a powerful treatment for young patients who suffer from Lennox-Gastaut syndrome or Dravet syndrome.

GW Pharmaceuticals boasts subsidiaries in Australia, England and Wales, Guernsey, and the United States. The company headquarters can be found in Cambridge, UK; in 2020, revenue soared to $527.2 million.

Japan May Soon Permit Medicinal Cannabis Product Imports and Consumption

On Thursday, September 29, a Japanese health ministry panel advised lawmakers to amend the country's drug laws to meet citizens' medical needs. The committee also attributed the recommendation to the ever-changing international standards that Japan needs to stay on top of.

Based on the details of the recommended revision, medical cannabis products in Japan would be subject to safety and efficacy laws equivalent to those associated with medical and pharmaceutical standards.

Although the cultivation, importation, sale, and possession of cannabis are still deemed criminal offenses in Japan, consumption is still legal. It is also legal to use CBD products produced from stalks or seeds. The panel also pointed attention that just 1.4% of Japanese citizens had used cannabis, as opposed to 20-40% in Western countries.

There is a chance that Japan might opt for medical cannabis legislation, but the country maintains a strict stance towards adult-use cannabis. In 2021, Japanese authorities made 5,482 cannabis-related arrests. Compared with Statista data recorded in 2014, this is almost triple the amount.

Elsewhere across Asia, cannabis policies and views differ. One of the first movers for medical cannabis legalization was South Korea, which legalized medical cannabis in November 2018. One month later, the Kingdom of Thailand followed suit.

So successful was Thailand's medical cannabis industry that the Kingdom's lawmakers took things one step further this past June by legalizing adult-use cannabis. It was the first Asian country to legalize adult-use cannabis at the federal level.

On the other end of the spectrum is Indonesia, where a judicial review of the country's narcotics laws and potential medical cannabis legalization was dismissed in July. Cannabis is also an illegal substance in China.

China's neighbor, Hong Kong, seeks to outlaw cannabidiol (CBD) by February - a move will abruptly halt operations for business owners currently selling CBD-infused supplements and drinks.

Source:

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2819831/
• https://www.statista.com/statistics/996474/japan-number-of-people-arrested-cannabis-drug- crimes/#:~:text=In%202021%2C%20the%20number%20of,were%20arrested%20for%20this%20crime.