Medical marijuana to hit local markets?

By Skandha Gunasekara

A new medication extracted from the marijuana plant will soon be available for Sri Lankan patients with a local company expecting to import the medicine to treat severe pain, if given approval by the State.

Marijuana was used for thousands of years with the earliest records of its use in the Indian subcontinent dating as far back as 2000 BC, during the Vedic period. In Sri Lanka too, it was used as part of Ayurvedic treatments since its inception.

Since the 20th Century, marijuana, also known as cannabis, was subject to legal restrictions for various reasons. The possession, use, and sale of cannabis are illegal in most countries of the world including Sri Lanka.

However, in the 1990s, following research evidence, cannabis was legalised in some countries for the use of medical purposes, including Australia, Canada, Chile, Colombia, Germany, Greece, Israel, Italy, the Netherlands, Peru, Poland, Portugal, and Uruguay.

The United States of America legalised it for medical use in 1996.

Fast forward to present day Sri Lanka, while the use of cannabis still remains illegal, it is known to be widely used in Ayurvedic treatments. Therefore, its introduction into western medicine in Sri Lanka, especially with the wide bodies of international research supporting its effectiveness, was only a matter of time.

Positive clinical trials

Ceyoka Healthcare and Pharmaceuticals entered into an agreement with Australian cannabis producer Creso Pharma to import the latter’s flagship product – cannAFFORD 50 – a pain relieving medication comprised of the cannabis extract cannabidiol (CBD).

The marijuana plant contains more than 100 different chemicals called cannabinoids.

Each one has a different effect on the body.

Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the main chemicals used in medicine.

THC also produces the “high” that people feel when they smoke marijuana or eat foods containing it.

Cannabidiol is one of the major constituents of cannabis.

CBD products are made from industrial hemp and come in various forms.

Although hemp and cannabis are in the same plant species, CBD products now on the market contain less than 0.3% THC (tetrahydrocannabinol), the cannabis compound that is the principal psychoactive constituent that gives the user a “high”.

Extensive research found that CBD was effective in treating a number of health problems including stress, anxiety, joint pain, post-traumatic stress disorder (PTSD), menstrual cramps, nausea, insomnia, addiction, autism, multiple sclerosis, other autoimmune disorders, as well as schizophrenia.

In 2018, the US Food and Drug Administration Agency approved the drug Epidiolex, an oral preparation of pure CBD for treatment of two rare and severe forms of epilepsy in children.

The drug is made by the GW Pharmaceutical Company and was tested in three randomised, double-blind, placebo-controlled clinical trials, including 516 patients. It was found to be effective in reducing the frequency of seizures.

Ceyoka Health, a subsidiary of the Nawaloka Group, is one of the leading pharmaceutical distribution companies in Sri Lanka, representing 30 companies, with a distribution network of more than 1,800 pharmacies and deals with pharmaceuticals as well as medical devices,
Creso Pharma – based in Barangaroo, New South Wales, Australia, is a pharmaceutical company focusing on cannabis products.

Founded by a team of highly-experienced pharmaceutical executives, Creso sets out to leverage cutting edge science and research to develop, register, and commercialise innovative cannabis and hemp-derived products for consumer use.

It also has an office in Switzerland, where cannAFFORD 50 is produced. It was the first company to import cannabis into Australia.

Potent painkiller

Ceyoka Healthcare Chief Executive Officer W.S. Premakumara, speaking to The Sunday Morning, said that the product, cannAFFORD 50, will be solely targeted for the treatment of chronic and severe pain management.

“This product will help those with severe pain such as post-accident pain, post-surgical pain, and pain during cancer treatment,” he said.

While noting that the cannAFFORD 50 was stronger than more commonly used artificial pain killers such as Codeine, Premakumara pointed out that it had no psychotropic effects whatsoever.

“This is one of its advantages – the lack of any psychotropic effects and the fact that it’s a plant-based product and not artificially manufactured.”

He said that if approved, it would be available only in select pharmacies that are registered with the Ministry of Health and would only be purchasable with a prescription issued by a medical professional.

Nevertheless, Premakumara said that the first step would be to have the product approved and registered with the Ministry of Health.

Government yet to decide

“We are in the process of preparing the registration dossier. We will apply for registration soon after.”

He said the pricing of the product would be calculated and decided once approval is given by the Government for its distribution in the Sri Lankan market.

Meanwhile, Creso Pharma’s Chief Executive Officer and Co-founder Dr. Miri Halperin Wernli told the media that Creso Pharma had found the perfect partner in Ceyoka Healthcare to distribute its products in Sri Lanka.

“In addition to their broad distribution network, this is a company (Ceyoka) which is heavily focused on investing in innovation. With Ceyoka, we found an ideal fit with Creso’s own philosophy and we anticipate a very long and successful collaboration,” Dr. Wernli said.

CannAFFORD 50 is a CBD lozenge designed to treat chronic pain. It is designed to dissolve in the mouth, ensuring it works faster than tablets or capsules as the active ingredients enter the bloodstream directly, without having to travel through the liver first.

National Medicines Regulatory Authority Director General and Chief Executive Officer Kamal Jayasinghe told The Sunday Morning that a committee of experts reviews any new product before it is approved for the local market.

Accordingly, the New Chemical Entity (NCE) is submitted to the Medicine Evaluation Committee, which consists of consultants from several fields as well as clinical pharmacologists.

“This committee will review the NCE and decide on whether to allow the medicine into the Sri Lankan market or not,” he said.
While noting that no applications have thus far been submitted for any CBD-based products, Jayasinghe said that the process of review would take no more than a month.

“The Committee meets once a month, so any new product would be reviewed by the expert committee and a decision would be reached within a month on whether to approve it or not,” he said.

Minister of Health, Nutrition, and Indigenous Medicine Rajitha Senaratne earlier told The Sunday Morning that the Government was looking into entering the medical marijuana industry that is booming worldwide.

He said that proposals had already been made to begin cannabis cultivation in Sri Lanka so that it can be processed into medical marijuana and exported to western countries such as the US.

The Minister noted that other countries had already begun this endeavor and that it was a market that Sri Lanka could enter easily as Sri Lanka had prime conditions for cannabis cultivation.