LUMC starts clinical study on fibromyalgia and cannabis

Can herbal cannabis be used to treat fibromyalgia symptoms that are not properly managed with standard therapy?

This year marks the start of a worldwide series of double-blind, placebo controlled clinical trials with standardised, pharmaceutical grade medicinal cannabis. The first trial is being conducted in Leiden, The Netherlands, where prof. dr. Albert Dahan of the department of Anesthesiology of the Leiden University Medical Center (LUMC) is leading a study on the effects of inhaled medicinal cannabis on fibromyalgia symptoms.

Fibromyalgia is a disorder characterised by widespread musculoskeletal pain and sensitivity to touch. These symptoms are frequently accompanied by chronic fatigue, sleep disturbance, and emotional changes. It is estimated that around 3 to 5 percent of the general population is affected by this disease. Interestingly and for unknown reasons, the majority (80 to 90 %) of patients diagnosed with this condition are women.

Commonly used pharmacologic treatments for fibromyalgia include the central nervous system depressant pregabalin (Lyrica®) and the selective serotonin and norepinephrine reuptake inhibitor duloxetine (Cymbalta®), both of which have received regulatory approval in multiple countries for the treatment of this disorder. However, while these medicines have been shown in clinical trials to be effective and relatively safe, not all patients have responded to treatment. In addition, in some patients they have been found to produce a variety of side-effects, including dizziness, drowsiness, or emotional changes which may lead to depression or even, in severe cases, suicidal thoughts.

Cannabis as an alternative treatment

Research shows that cannabinoids – the active compounds present in the cannabis plant – can have a beneficial effect on fibromyalgia symptoms by reducing pain and improving sleep quality. Although cannabis has not been established as an approved medicine for this medical condition, surveys indicate that fibromyalgia patients already self-medicate using cannabis. Moreover, some patients have reported cannabis to produce fewer side-effects than the available conventional treatments and, most importantly, to be effective.

Clinical study

Bedrocan International – licensor for production of standardised, pharmaceutical-grade medicinal cannabis – hypothesises that herbal cannabis can be used to treat fibromyalgia symptoms that are not properly managed with standard therapy. For that reason, the LUMC is conducting a study that evaluates how the symptoms of fibromyalgia are affected by the two major cannabinoids (the active pharmaceutical ingredients) of the cannabis plant: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Specifically, a group of patients is being administered these two compounds in the form of vaporized herbal cannabis. The three different investigated drug products are Bedrocan®, Bediol® and Bedrolite®, which are standardised medicinal cannabis varieties that are legally available in The Netherlands. During the study, patients are being subjected to different established measurements and tests that will provide information about the efficacy of the medication in reducing both the physical, as well as cognitive and affective, symptoms of fibromyalgia. It is hoped that the obtained information will push standardised medicinal cannabis forward as a possible alternative treatment for fibromyalgia, particularly for patients who do not respond, or do not respond sufficiently, to existing treatments.

Bedrocan becomes world’s first GMP producer

Following a rigorous inspection by the Dutch Health Care Inspectorate, Bedrocan in the Netherlands has become the world’s first producer of medicinal cannabis to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards. This is the first time a medicinal cannabis producer has reached such a high level of compliance. Bedrocan’s production facilities in Canada and the Czech Republic are expected to become fully compliant next year.

GMP is the highest standard a medicine manufacturer must meet in its production process. Bedrocan’s GMP status is a guarantee of the highest quality in both its cultivation and packaging process.

Tjalling Erkelens, Chairman of Bedrocan International, said: “This is a significant recognition. We have always aimed to meet the highest pharmaceutical standards. Now our way of working is officially recognised by the authorities.”

Since 2003, Bedrocan has produced standardised medicinal cannabis as an active pharmaceutical ingredient (API). It is the only company in the world to produce cannabis flos (the whole, dried flower) with a constant composition of cannabinoids and terpenes.

Bedrocan’s Dutch-made medicinal cannabis supplies patients and researchers in the Netherlands, Germany, Finland, Israel, Italy, Macedonia and Poland. In Australia it is used in Australia’s first clinical trial of vaporized cannabis flower bud.

Perry Davidson, CEO and founder of Israel’s Syqe Medical, which incorporates Bedrocan’s medicinal cannabis in its metered-dose inhaler said: “Syqe Medical has developed the world’s first inhaler that delivers medicinal cannabis with the level of precision of traditional medicines. A key factor in our ability to provide a pharmaceutical-grade solution is Bedrocan’s standardised product and uncompromising quality. The GMP compliance achieved by Bedrocan marks a major leap forward for medicinal cannabis, and its acceptance as a mainstream treatment by the medical community.”

In Canada and the Czech Republic, Bedrocan’s unique production methods are licensed to exclusive partners.

Bedrocan’s cannabis used in clinical trial Australia

The first of its kind in Australia, Bedrocan’s cannabis flos and placebo will be used in a cancer palliative care clinical trial. Led by Professor Meera Agar, the double-blind randomised controlled trial will explore whether vaporized medicinal cannabis flos can promote appetite and improve quality of life. For people with cancer, the pathways that promote appetite are disrupted. Their quality of life is reduced due to fatigue, low mood, nausea and insomnia – aspects critical to health and wellbeing.

Researchers are now recruiting patients. Approximately 30 adult patients with advanced cancer will be included in the trials undertaken at Sydney’s St Vincent’s Sacred Heart Health Service and Newcastle’s Calvary Mater Hospital. The results may lead to a further trial, enrolling up to 250 patients from metropolitan and regional hospitals across the state.

The New South Wales Minister for Medical Research, the Hon. Pru Goward, fully supports the trial as part of the state Government’s $21 million funding commitment to medicinal cannabis clinical trials and reforms. To learn about the NSW Government’s Centre for Medicinal Cannabis Research and Innovation and the trial see www.medicinalcannabis.nsw.gov.au.

For more on vaporization as a way of administering cannabis flos, read our article Not all vaporizers are the same.

Placebo for use in clinical studies

Modern clinical trials are typically performed as double-blinded, placebo-controlled studies. To meet these needs, Bedrocan now offers placebo versions of all of our strains for use in clinical studies. Each placebo contains the precise terpene profile of the original strain, with all cannabinoids removed.

The method we use to turn active cannabis into placebo uses homogenised cannabis as the starting material. We do this through a process called granulation, where the cannabis is broken up into smaller particles. For that reason, placebo material only comes in the form of granulate.

Full HPLC (high-performance liquid chromatography) and GC (gas chromatography) profiles are available on request, showing detailed information about cannabinoid and terpene content of all varieties.

Click here for more information about our placebo.

placebo-medicinal-cannabis-by-bedrocan-6

Towards a clearer classification of medicinal cannabis varieties

Detailed chemical analysis shows clear differences between Sativa and Indica types of cannabis.

The terms Sativa and Indica have been used for centuries by cannabis cultivators and end users to identify certain types of cannabis. Patients have learned to use these terms to navigate their search for their favorite variety, but it was unclear how this reflected actual differences in chemical composition and medicinal effects.

A recently completed study, commissioned by Bedrocan International, shows that certain terpenes are the chemical markers that distinguish Sativa from Indica type cannabis. The use of biochemical markers is a useful addition to the commonly used classification system based on popularized vernacular or ‘cultivar’ classification names such as Amnesia Haze or Purple Kush. A more advanced scientific approach makes it easier to discover varieties with chemical composition (‘chemovars’) that better match patients’ pharmacological needs.

In his study, titled ‘From cultivar to chemovar II’, Dr Arno Hazekamp analysed the largest collection of cannabis samples (460) reported in scientific literature. Samples were chemically mapped and divided into clusters with similar composition. The study showed that Sativa and Indica samples were clearly different on a chemical level, with certain terpenes as the main markers. Hydroxylated terpenes (also known as terpenoids) were significantly more prevalent in Indica type samples. Opposite to common belief, Sativa and Indica types did not differ in their average content of THC or CBD.

Bedrocan sells its shares in Canopy Growth Corp

Bedrocan International recently sold its remaining shareholdings in Canada based Canopy Growth Corporation (CGC). Herewith the licensor of the global Bedrocan brand underlines its medical disposition in Canada. Bedrocan International distances itself from Canopy Growth’s clearly expressed future strategy, aiming for large scale production of cannabis for recreational use under the expected legalization in Canada by the Trudeau government. Bedrocan International remains fully committed to support and upgrade the Canadian Bedrocan facility acting solely under the name Bedrocan Canada to the highest technical and pharmaceutical standards for it to meet increasing demand and the need to be GMP-compliant. Thus serving the needs of Canadian patients and their physicians.

It is Bedrocan International ‘s strong belief that there should be a clear distinction between medicinal and recreational use of cannabis and that patient needs for safe and consistent cannabis is a priority. Bedrocan International’s founder and chairman of the board, Tjalling Erkelens is convinced that this can be achieved: “Cannabis can and should go through the drug approval process. Fully standardised medicinal cannabis is the foundation on which such approval can be achieved.”

Bedrocan Canada Inc. (wholly owned by CGC) is a licensee of Bedrocan’s brand, cultivation methods and processing technique. CGC doesn’t produce or sell medicinal cannabis. Besides  Bedrocan Canada, CGC also owns Tweed Inc and Tweed Farms.  Bedrocan (International)’s chairman of the board Tjalling Erkelens: “Bedrocan is increasingly recognised as the leading authority in the medicinal use of cannabis worldwide. Cannabis to us is not a lifestyle product. It is a medicine, that should be effective, safe and affordable for any patient. We at Bedrocan International emphasize this in our mission and vision.”

It is the ongoing intention of Bedrocan International to serve patients in Canada with medicinal cannabis only of the highest quality. With this defined position, along with a renewed production facility, Bedrocan International looks forward to further fulfilling its mission and vision in Canada with Bedrocan Canada as its exclusive licensee in Canada.

Irradiation does not affect medicinal cannabis

Gamma-irradiation does not cause significant changes in the composition of medicinal cannabis. A recent study has shown that the most important therapeutically active components THC and CBD are not affected by the radiation. Herbal cannabis products, often used by vulnerable patients, are treated by gamma-irradiation to free them from contamination with potentially harmful microbes. Patients have occasionally expressed their concerns about the effects of irradiation treatment on medicinal cannabis. Some have claimed a change of taste or effect, while others worry about changes in the chemical composition or the quality of their medicine.

The study evaluated the effects of irradiation treatment on four different cannabis varieties covering different chemical compositions. Samples were chemically analysed before and after standard gamma-irradiation treatment. In addition, water content and microscopic appearance of the cannabis flowers was evaluated.  The effect of gamma-irradiation was limited to a slight reduction of some terpenes present in the cannabis, but keeping the terpene profile qualitatively the same. No effects on THC or CBD content was observed.

Based on the study results gamma-irradiation of herbal cannabis remains the recommended method of decontamination, at least until other more generally accepted methods become available.

The study was undertaken by Dr Arno Hazekamp, an international authority on biochemical cannabis research, and commissioned by Bedrocan.

Not all vaporizers are the same

Many of us have heard of vaporizers, and instantly we think of ‘e-cigarettes’ or ‘vape-pens’. However, these are not the only types of vaporizer available.

This article discusses the topic of administering cannabis flos by vaporization and inhalation into the lungs. It explores several aspects of vaporization, highlighting the importance of using medical grade administration devices in combination with standardised, pharmaceutical quality cannabis flos.

Pharmaceutical quality cannabis flos

For vaporization to be truly effective, the cannabis product used with it must be of pharmaceutical quality. Fully standardised cannabis flos assures dosage composition, repeatability and the ability for patient and prescriber to effectively adjust dose by titration. A critical factor to build the evidence-base of medicinal cannabis, it is essential to be able to compare findings from different clinical trials and studies across time. That means the exact quality and dose of the cannabis, used for different conditions, should be known.

Finally, pharmaceutical quality cannabis flos is required from a public and patient safety perspective. Cannabis flos must be free of contaminants such as microbes, pesticides and heavy metals, qualities that make the vapour safe for inhalation into the lungs.

An efficient administration route

The most efficient administration route of medicinal cannabis is by inhalation. Indeed, administration by inhalation is a rapid way to induce measurable serum levels of cannabinoids.

“The most efficient administration route of cannabis is inhalation …the use of a vaporizer medical device avoids the respiratory disadvantages of smoking.”

A vaporizing medical device, compared to smoking, dramatically lowers concentrations of toxic compounds such as carbon monoxide, ammonia and polyaromatic carbohydrates (PACs). Compared to smoking, higher therapeutic levels of THC and consistent, reproducible THC extraction and delivery is possible. The vapour is quickly absorbed by the lungs, permitting patients to effectively titrate to optimise their dose based upon symptom severity, tolerability and avoidance of side-effects. The rapid onset of effects of inhaled cannabinoid use allows easier titration of dose, while standardised cannabis products enable patients to administer an exact dose.

In practice, with prescriber guidance, patients initially focus on finding a dose range that works for their specific condition. On average, patients in the Dutch medicinal cannabis program use only 0.7 grams of cannabis flos per day, divided over multiple doses.

Smoking cannabis in the form of cigarettes (joints) is still the most common way of consumption today, for medical as well as recreational users internationally. The advantage of vaporizing over smoking is obvious with regard to irritation and respiratory complication resulting from smoking. The presence of non-THC constituents, including anti-inflammatory terpenes that protect the lungs from irritation, are present in the cannabis flos vapour. This makes vaporizing the obvious and healthier choice for administration of the full range of therapeutic compounds present in the cannabis plant.

Patient perspectives and providing options

The importance of vaporization is underlined in patient use surveys. The majority of survey respondents report higher satisfaction (approval) scores with the inhalation route. In general, whole plant, herbal cannabis-based medicines received higher scores than other products containing isolated cannabinoids.

While smoking may be a popular administration method internationally, it is evident patients are looking for alternatives to smoking. Patients seek a reliable, affordable and portable vaporizer for administering cannabis flos. Presently there is research dedicated to advancing administration technology. Some examples of major developments in vaporizer medical devices, using standardised cannabis flos, include the Volcano® Medic vaporizer (Storz & Bickel), the Syqe® Inhaler (Syqe Medical), and the Bedrovape® vaporizer.  All devices have relied on Bedrocan standardised cannabis flos for their quality testing and clinical trials.

vaporizer-bedrocan

Vaporizer medical devices, delivering standardised doses, underline quality assurance, safety, and efficacy. With these administration technical advancements, smoking of cannabis flos can soon be a thing of the past. Backed by proper scientific studies, medicinal cannabis flos will become an acceptable therapeutic among patients, prescribers, and regulatory authorities.

Second hand exposure

The content of exhaled cannabis vapour contains no pyrolytic compounds for second-hand exposure. However, it is not exactly known how exhaled vapour is dispersed in the air, and whether there may be significant levels of cannabinoids present in the exhaled vapour. No vapour cloud dispersion studies have yet been conducted. As a result, it is undetermined if passive intake of cannabinoids would present an occupational hazard to health professionals and other carers. While the levels are not likely critical to health and safety, this is an important future research to be undertaken.

Vaporizer

Inhalation

Administration
Absorption via the lungs may reduce total daily intake.

Flos or granulate

Dose Type
Cannabis flos and granulate. A vapour of cannabinoids and terpenoids.

Onset Fast

Onset
Highly efficient and fast acting. Between 2-10 minutes.

Duration

Duration
Between 2-4 hours.

Safety

Duration
Between 2-4 hours.

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