Updates

The UMC Utrecht Brain Center, in collaboration with various organisations in the Netherlands, will conduct research into the effects of adding medicinal cannabis to the treatment of children with treatment-resistant epilepsy. The study drug to be administered is the Bedrolite® oil from the  Dutch Transvaal pharmacy. This medicinal oil is made from Bedrocan’s cannabis. The research group has been allocated 1.4 million euros from ZonMW s Good Use of Medicines programme, which funds research in the Netherlands. The research will take about four years.

A total of 50 patients can participate in the study. Importantly, the patients have not previously used CBD oil to treat epileptic seizures. In the first instance, the medicine’s effect on the attacks is examined, which is why participants must have a minimum of eight attacks every four weeks. Otherwise, the effectiveness cannot be assessed.

The study will start in the summer of 2023, and the first patients are expected to be treated by the end of 2023.

Lead researcher Floor Jansen hopes that after the research, neurologists can better predict for which patients CBD (cannabidiol) is an effective treatment. You can read more about this on the UMC’s website. Jansen: “Our research focuses on the individual. Instead of looking at a group, we look at whether the drug is effective per patient. We want to investigate whether the number of attacks decreases, but we also pay attention to other important outcomes for a patient. Think of less use of emergency medication against prolonged attacks, a change in alertness or a better night’s sleep.”

Practitioners of children with epilepsy who would like to know more about the study can contact Floor Jansen, pediatric neurologist at UMC Utrecht (via the secretariat of pediatric neurology at UMC Utrecht, Netherlands).

Bedrocan highly welcomes that drastic restrictions of patient’s access to medical cannabis discussed in Germany are off the table. The German G-BA (Federal Joint Committee, a decision-making body regulating reimbursements for patients with public health insurance in Germany) decided on March 16 to cancel plans to tighten the currently applicable rules for prescribing medical cannabis. According to the original G-BA draft, most doctors could have lost their right to prescribe medical cannabis and health insurances could have refused a larger proportion of prescriptions. As the largest supplier of medical cannabis in the EU and the only purely pharmaceutical market player with an exclusive focus on patients, Bedrocan is pleased with the fact that the initially proposed restrictions are not being implemented.

Bedrocan CEO Jaap Erkelens comments: “Our experiences from Canada and the Netherlands show that such restrictions would have led to shortcomings for suffering patients. They would have been forced into the black market and into medically unaccompanied self-medication. We are relieved that decision makers in Germany understand this danger, which increases even further with the planned liberalisation of recreational cannabis. Before that liberalisation, patients’ access to medicinal cannabis should not become more difficult but easier.”

Some patients go to the coffee shop rather than to a doctor. Others grow their own cannabis. These are just two examples of how patients obtain cannabis for medicinal use in the Netherlands. According to figures from the Trimbos Institute, more than 130,000 people in the Netherlands use cannabis for medicinal purposes. Of these, fewer than 7,000 patients are prescribed cannabis by a doctor. Therefore, most of them get their cannabis from other sources, such as coffee shops or growing it themselves.

To understand how access to and supply of medicinal cannabis can be improved, the Trimbos Institute is conducting an independent survey among cannabis users. The online questionnaire is already live. The research and knowledge institute in the mental health and substance field hopes to map out patients’ needs and wishes. Bedrocan finances the research.

Patients’ voice

According to Trimbos Researcher and Project Leader Lisa Strada, it is common knowledge that patients use weed, hashish, cannabis oil or other cannabis products to reduce physical or psychological complaints. Strada: “Based on more recent findings, almost half a million people use cannabis-based products for medicinal purposes. Of these people, 50% use CBD products, including CBD products from drugstores.” Strada continues: “With this research, we want to give these patients a voice. Patient-centred care means that the patient’s needs are the driving force behind care decisions. And while this is the norm in other healthcare sectors, medical cannabis treatment is lagging in this regard.”

Since 2003, patients in the Netherlands have been able to obtain cannabis from pharmacies on a doctor’s prescription. Chief Scientific Officer Mikael Kowal of Bedrocan: “Despite the fact that medicinal cannabis has been available in the Netherlands for twenty years, most people do not get their products from a pharmacy. It’s important to understand why so many people choose the unofficial route. What obstacles do they experience? Is cannabis from pharmacies too expensive, do doctors not want to prescribe it, or are specific products missing? It’s guesswork. We don’t know now.”

Kowal hopes the outcome will lead to change: “We will have to come up with strategies to meet the needs of patients who are now using cannabis from non-official sources. The aim should be for more patients in the Netherlands to use standardized, controlled and safe cannabis, instead of products of unverified quality.”

Medusa research

The first part of the Medusa study is an online questionnaire. Filling it in takes 10-15 minutes, and participants can win 200 euros in a sort of lottery. Some sample questions asked:

• For which complaints do you use cannabis?
• What cannabis products do you use?
• How well does cannabis work against your complaints?
• Why don’t you use cannabis on a doctor’s prescription?

After the questionnaire, participants can participate in follow-up studies. They can choose one of these follow-up tests or both, and participation is voluntary. One is an online interview, and for the other, they can send in a bit of their cannabis. Participants receive a reimbursement of 40 euros per follow-up study.

A new study shows that cannabis, and in particular the THC component, has no effect on the breathing system. The Leiden University Medical Center (LUMC) has conducted research into this. The outcome is important safety information when using cannabis for medical purposes.

There is not much knowledge on the effect of cannabis on ventilatory control – the unconscious and automatic process of breathing. The clinical study at the LUMC administered vaporized Bedrocan® to 18 volunteers to study the effect of THC on breathing with and without the addition of an opioid. Since opioids can potentially cause life-threatening respiratory depression, it is important to understand if combining opioids with cannabinoids can intensify this problem. It is possible that such a combination of products will be used in the treatment of chronic pain. Fortunately, the results of the clinical trial suggests that THC has no effect on ventilatory control.

Below you can find the original abstract of the study, executed by the research team of professor dr Albert Dahan.

Can higher CBD levels reduce the harmful effects of cannabis use? That is the question that researchers from King’s College London tried to answer in a psychopharmacological study of forty-six healthy participants, who had little or no experience with cannabis use. The group received various cannabis preparations with 10 mg THC and a varying CBD content (0, 10, 20 and 30 mg) via a vaporizer, in a double-blind and randomised study. The cannabis used for the study originated from Bedrocan and was produced in accordance with Good Manufacturing Practice.

Fifteen minutes after cannabis inhalation, participants completed a series of tasks measuring mental abilities and reported how “pleasant” they experienced the cannabis. They also went on a 15-minute ‘hospital walk’, with the task of buying a £2 item of their choice from a cashier in the hospital shop. They had to ask for a receipt. They were observed from a distance by the research team. After any intoxicating effects had subsided, psychological questionnaires and a semi-structured clinical interview were administered.

No evidence

The researchers found no evidence that CBD reduces the acute adverse effects of THC. In terms of cognition, the adverse effects of THC mainly refer to effects on attention and memory. In terms of mental health, this mostly relates to the emergence of psychotic symptoms.   Also, there was no evidence that it changed the subjective or pleasurable effects of THC. This was the case for all CBD:THC dose ratios used in the study.

Interesting data

Bedrocan’s Chief Scientific Officer Mikael Kowal about the outcome: “This is interesting data which is somewhat contradictory to previous research on the interactions between THC and CBD, in which CBD has been shown to reduce some of the negative effects of THC. It is difficult to say which factors contributed to these different results, however there is a possibility that the differences are related to the use of specific cannabis varieties. Specifically, the current study used Bedrocan® and added various amounts of Bedrolite® to the THC-rich variety, in order to achieve the desirable amounts of CBD. Possibly, using a cannabis variety that already contains both THC and CBD (like Bediol®) would yield different results. This is only speculation, but in such a case it may be possible that other compounds in cannabis, aside of CBD, contribute to modulating the effects of THC.“

Bedrocan is expanding its production capacity with the establishment of a new GMP-approved facility for the cultivation and packaging of medicinal cannabis in Denmark. The new facility will be located in Køge, which is 30 kilometres south of Copenhagen.

Meeting international demand

The main reason for Bedrocan to expand into Denmark is to better meet the growing international demand for its high-quality medicinal cannabis products. Under the current legal framework in the Netherlands, Bedrocan’s products are only available via the Dutch Office of Medicinal Cannabis (OMC), part of the Ministry of Health. Bedrocan expects to significantly improve the availability of its products to vulnerable patients globally. In Denmark, Bedrocan can conduct business directly with other commercial entities.

The new facility will comply with all relevant regulatory requirements (GACP and GMP). Products from this facility are initially meant to supply European medicinal cannabis markets. The facility will employ approximately 40 staff and will be operational by the end of 2023.

Products

The facility starts off by producing some of the currently known Bedrocan varieties, such as Bedrocan and Bediol, plus a new high CBD variety. The dried cannabis products are processed in a cut form (sometimes referred to as granulate) in small and large packaging. For the manufacturing of extracts and isolates, it is also possible to obtain whole-plant cannabis from the Danish facility.

If you have any questions regarding this announcement, please contact our business department at business@bedrocan.com.