The tendering procedure for the cultivation of medicinal cannabis in Germany was bumpy from the start. After the first procedure was stopped, the Federal Institute for Drugs and Medical Devices (BfArM) started the next round in July 2018. But even here there were delays. First the application deadline was extended twice and then the contract was awarded. Nonetheless, the BfArM insisted on being able to bring in the first harvest in Germany this year.

According to a recent report of the pharmacy adhoc, the cannabis producers Aurora, Aphria and Demcan will not be able to harvest German cannabis this year. The blame lies with the corona crisis. As a result, the competent authorities were unable to issue the necessary BtM (narcotics) and GMP certifications in time.

Producers confirm delays

At present Aurora is preparing to start up its production plant in Leuna and made an ad hoc statement according to the pharmacy:

“We look forward to starting production as soon as all necessary steps for production preparation and regulatory approvals have been taken – some of these steps will take longer than originally expected and planned due to the ongoing pandemic. Aurora regularly discusses the progress of the project with the Cannabis Agency and agrees on how to proceed and any delays in the schedule. The first delivery will probably be postponed until next year”.

The Berlin-based start-up Demecan is also planning production near Leuna. In Ebersbach, near Dresden, the company acquired a former slaughterhouse from the insolvent cannabis company Wayland. Now the cannabis production has to be adapted to the new conditions, making a harvest this year impossible.

“Our aim is to start plant cultivation as soon as possible in order to guarantee delivery to the Federal Institute for Drugs and Medical Devices as soon as possible in the new year”, Demecan said ad hoc according to the pharmacy.

The delay in the cannabis harvest was also confirmed by Aphria, whose production plant is located near Neumünster. Delivery is planned for the first quarter of 2021.

No changes on the German cannabis market

The delays in the German cannabis harvest due to the corona crisis are understandable. However, the imported medical cannabis is not sufficient, which is why BfArM had to apply for the approximately 12.4 tons.

But even if German cannabis is available next year, the 2.6 tons per year may still be far from sufficient, so that Germany will probably continue to depend on companies such as CanPharma, which import medical cannabis into Germany.

Source: https://mjbizdaily.com/germanys-first-medical-cannabis-harvests-likely-delayed-until-2021/

https://www.apotheke-adhoc.de/nachrichten/detail/markt/bfarm-cannabis-dieses-jahr-keine-ernte/?tx_aponews_newsdetail%5B%40widget_4%5D%5BcurrentPage%5D=2&tx_aponews_newsdetail%5B%40widget_4%5D%5BitemsPerPage%5D=1&cHash=25c7ab284ce95b6f9449e330a777fc2a

Obsessive-compulsive disorder (OCD) is a mental disorder in which patients suffer from obsessive-compulsive thoughts or actions. Although patients are aware that this compulsion is excessive, they have to give in to the urge. Depending on the severity of the disorder, the patient’s daily life may be considerably impaired.

The causes have not been definitively clarified. Psychological explanatory models are being discussed, as well as disorders involving neurotransmitter metabolism as risk factors. There is also evidence of the involvement of various other signalling pathways, such as the glutamatergic, dopaminergic or GABAergic system.

OCD: involvement of the endocannabinoid system

Various studies, in particular a small number of animal experiments, suggest that the endocannabinoid system may be involved in the pathophysiology of OCD.

In 2019, researchers from Columbia University published a review on whether the endocannabinoid system could be a new treatment target for OCD. In addition to a comprehensive review of endocannabinoids and phytocannabinoids, the researchers also presented data from different trials.

In two case reports, the researchers said that treatment with dronabinol had positive results in two patients with OCD who were refractory to treatment. Data from a small open-label, uncontrolled trial also showed that the combination of nabilone and psychotherapy was more effective than any treatment on its own.

In summary, the researchers stated the following:

“Is there a place in psychiatry for cannabinoid-based drugs? Studies in animals and humans have shown that the endocannabinoid system is an important emotional regulator. But how can we use this knowledge for therapy? This review article offers a critical evaluation of the evidence focusing on obsessive-compulsive disorders and provides pointers for future research.”

Medical cannabis in the treatment of Tourette’s syndrome

Patients with Tourette’s syndrome suffer from chronic vocal and/or motor tics, often associated with comorbid obsessive-compulsive behaviour. Various studies and clinical trials have shown in the past that patients with Tourette’s syndrome can benefit from treatment with medical cannabis. After taking various cannabis-based medicines (Sativex, medical cannabis flowers), patients reported an improvement in tics.

Recent case report of a patient with OCD

In a case report, a 22-year-old patient was presented suffering from a severe obsessive-compulsive disorder since childhood. The treatment with medical cannabis significantly reduced the symptoms of OCD. His depression also improved, leading to a significant improvement in his quality of life.

Source:
https://www.eurekalert.org/pub_releases/2019-05/mali-cch053119.php
https://pubmed.ncbi.nlm.nih.gov/32848902/

The Federal Institute for Drugs and Medical Devices (BfArM) has set out to tender a quantity of 10.4 tonnes of medical cannabis over four years in Germany. However, this quantity is far from sufficient to cover demand. Import dependency is expected to remain.

In the German government’s response to a minor enquiry from the FDP parliamentary group, it was stated that the import demand for medical cannabis has grown to 14 times its size between 2015 and 2019. This year, as in previous years, the BfArM had to apply retroactively for an increase in the import volume, namely of 75 percent. According to the Federal Government, however, supply bottlenecks are not to be expected.

The use of a complicated import procedure instead of strengthening domestic production

The German government regulates the supply of medical cannabis by means of an import procedure requiring approval. In advance, the Federal Opium Agency must report the expected demand to the BfArM and the International Narcotics Control Board (INCB) by the 30^th of June.

The estimation of the demand includes medical cannabis flowers for direct delivery to the patient as well as cannabis flowers for the production of extracts, dronabinol and finished drugs. The quantities of cannabis needed for clinical trials and research must also be considered.

“The estimate is based on the consumption data available up to the 30^th of June of a given year, their development within the previous year and taking into account the quantities of stocks held by participants in the legal narcotics trade,” says the Federal Government.

The demand for medical cannabis is constantly increasing

The FDP criticises the above-mentioned approach because the demand for medical cannabis is constantly increasing and the estimated quantities are not adjusted. According to the online magazine Apotheke Adhoc, the authorised import volume was 1485 kilograms in 2015, 1500 kilograms in 2016, 10,380 kilograms in 2017, 10,688 kilograms in 2018 and 20,774 kilograms in 2019. In all these years, a re-estimate had to be made because the imported quantity was not sufficient.

The authorised import quantity for 2020 is 16,100 kilograms. This is over four tonnes less than in 2019.

“As this figure is expected to be exceeded before the end of 2020, BfArM has already applied to the INCB for an increase in the quantity as part of a reassessment of the expected additional medical and scientific need for 2020 totalling 12,355 kilograms,” explained the Federal Government.

The INCB has yet to reply.

The Government also stated that there were no plans to increase the quantities cultivated in Germany. According to Apotheke Adhoc, FDP health policy expert Dr. Wieland Schinnenburg criticised that this was a missed opportunity. At the same time, he called for a strengthening of cannabis cultivation in the country.

“The planned harvests in Germany cover only a fraction of the actual demand. We must minimise our dependence on imports and increase production volumes in Germany. The lucrative export market should also be opened up to German companies. There is no reason to discriminate against German companies and exclude them from the world market,” said Dr Schinnenburg.

Sources:
https://dip21.bundestag.de/dip21/btd/19/214/1921416.pdf
https://www.apotheke-adhoc.de/nachrichten/detail/politik/cannabis-bfarm-verschaetzt-sich/

According to the online magazine DAZ.online, the Association of Cannabis Supplying Pharmacies (VCA) is now advocating a prescription requirement for CBD products. However, the VCA believes that the classification of cannabidiol (CBD) as a narcotic is not necessary.

In many pharmacies the demand for CBD products is increasing, because it is said that they have a calming, sleep-inducing and pain-relieving effect. However, it is problematic that CBD products are not produced according to standardized procedures and that therefore no studies according the long-term effect exist. In addition, the legal situation in Germany is unclear. Some products are available as food supplements and others as medicals.

The report further says that “CBD preparations according to NRF prescription (Oily Cannabidiol Solution 100 mg/mL NRF 22.10. and Oily Cannabidiol Solution 50 mg/mL NRF 22.10.) are not available only on prescription. The CBD-drug Epidyolex is, however, only available on prescription, which unsettles pharmacists and raises the question whether the marketing of CBD products is permissible.

CBD products: No classification as narcotic

In a statement, the VCA said that it is not necessary to classify CBD as a narcotic because it does not have a psychedelic effect. Nor is there any danger of addiction. Instead, it would be necessary to make products containing CBD available only on prescription.

“CBD is an important ingredient of the cannabis plant, which both influences the effect of THC and can itself trigger significant effects through its ability to activate specific receptors of the body’s endocannabinoid system,” the VCA said according to the media report.

According to the VCA, CBD has great therapeutic potential. That’s why they say that the cannabinoid has to be classified as a drug substance – just like the CBD drug Epidyolex. The VCA is critical of the classification as a food supplement.

“The initially consistently positive reporting in various magazines and sales-promoting announcements on countless manufacturer sites on the Internet aroused people’s curiosity about this potential panacea,” the association says. “CBD is more than just a hope for patients and has very good pharmacological effects. Even if the long-term effects have not yet been researched, it deserves the chance to be perceived as an effective drug,” the VCA said.

CBD products: Prescription requirement as a solution?

The VCA sees a solution in the fact that CBD products are sold through pharmacies as prescription-only preparations or finished drugs.

“A classification of CBD as a standardized prescription-only substance, whether as a prescription preparation or as a ready-to-use drug such as Epidyolex, supplemented by its eligibility for reimbursement under the statutory health insurance system, is completely sufficient in the eyes of the VCA to give CBD the opportunity to develop where it really needs to arrive: For the sick person who needs help,” the VCA concludes in its statement.

Sources: https://www.deutsche-apotheker-zeitung.de/news/artikel/2020/08/26/cannabis-apotheker-fordern-rezeptflicht-fuer-cbd-produkte/chapter:1, https://vca-deutschland.de/stellungnahme-des-vca-zur-angedachten-einstufung-von-cannabidiol-cbd-als-betaeubungsmittel-btm/

The Israeli scientist Dr. Raphael Mechoulam is a pioneer in the science surrounding cannabis. As early as the 1960s, he isolated the cannabinoids cannabidiol (CBD) and tetrahydrocannabinol (THC).

In autumn of 2019, the scientist then announced that he had discovered a new synthetic cannabinoid. According to him, this is more potent than CBD or THC. After several months of testing, Mechoulam and his team of researchers found that the new compound called cannabidiol methyl ester (EPM301) could be effective in the treatment of inflammation, nausea and anxiety.

Together with his research team at the US based biotech company EPM, he patented the new compound. EPM301 is the synthetic version of a natural acid found in the cannabis plant. It has long been known that the cannabis plant contains numerous acids, such as CBDA or THCA, and that these can be very effective. However, these acids are very unstable.

Modification and Stabilisation of Acids

The instability of the acids makes it difficult to isolate them from the cannabis plant so that they can be used for medical purposes. However, Mechoulam and EPM seem to have found a way to modify and also stabilise them. The researchers used an esterification process to accomplish this. This means that two chemicals combine to form the stable ester compound.

According to a media report, Mechoulam explained that EPM had developed a method “to work with the original substances of cannabis”. He told Forbes magazine:

“So, while everybody is discussing THC and CBD, these cannabinoids are actually a secondary substance; they only appear later in the plant. Originally there is an acid that appears in the plant, and those acids are these mysterious worlds of compounds that are much more potent than cannabinoids.”

The Therapeutic Potential of the New Cannabinoid

In recent months, Mechoulam and EPM have started to explore the therapeutic potential of the new cannabinoid EPM301. Preliminary results of the research suggest that the cannabinoid may be able to relieve anxiety and suppress nausea without causing side effects. EPM301 is also believed to be effective against inflammation. Further research, in particular clinical trials, is needed to confirm these initial positive results.

Sources:
https://www.hanf-magazin.com/news/dr-raphael-mechoulam-isoliert-neues-cannabinoid-mit-medizinischem-potenzial/?fbclid=IwAR2xrfTEp3LEBnK3c4wh3Ld2VZ_uHN7Eydeo7RSk6R_vAtjvvGcRxE51Kfg
https://www.forbes.com/sites/javierhasse/2020/07/12/dr-mechoulam/

In May of this year, we already reported on studies investigating the effect of cannabidiol (CBD) on the lung disease COVID-19. Israeli researchers are planning to conduct clinical trials on patients to find out to what extent CBD is able to regulate the immune system and inhibit inflammation. Besides the effect of CBD on COVID-19, the researchers also want to investigate the therapeutic potential of cannabis with all its cannabinoids.
The results of a study conducted at Augusta University of Georgia in the USA have now been published.

Most corona infections are mild. However, patients who become seriously ill with COVID-19 are dependent on intensive medical care and in the worst case may even need to be ventilated because an inflammatory reaction develops in the lungs. The lungs are then literally flooded with inflammation-promoting messenger substances, so that doctors speak of a “cytokine storm”. According to the current study, the non-psychoactive cannabinoid CBD seems to help against this.

Results of the study

In some patients COVID-19 causes an excessive production of pro-inflammatory substances such as the interleukins IL-6 and IL1ß. Due to the inflammation, the function of the lungs is severely impaired. It is hardly able to absorb oxygen from the blood and release carbon dioxide into the blood. As a result, the lung tissue is damaged and the patient must be ventilated.

The researchers found in animal experiments that CBD was able to reduce the incidence of infection and lower body temperature. At the same time, the lungs regenerated faster. CBD was also able to improve the oxygen supply.

Clinical studies are necessary

Although the results of the study are promising, clinical trials are lacking. Especially, to find out how treatment with CBD in patients could look like. The researchers also state that the coronavirus can attack other organs. Therefore, further studies are needed to investigate the effect of CBD on other organs that are damaged by the virus, such as the heart, brain and intestines.

https://www.liebertpub.com/doi/10.1089/can.2020.0043

Antiseptic mouthwashes are often used for prophylaxis in the oral cavity. Depending on the ingredients, such as chlorhexidine, cetylpyridinium chloride, floride or alcohol, these are said to be effective against gum inflammation, tooth erosion, plaque or caries.

Belgian researchers have now carried out an interesting study in which they added the cannabinoids cannabidiol (CBD) and cannabigerol (CBG) to mouthwash products and had volunteers test them.

The antiseptic effect of cannabinoids

In addition to the well-known cannabinoids tetrahydrocannabinol (THC) and cannabidiol (CBD), the cannabis plant contains more than 100 other cannabinoids, including cannabigerol (CBG). Various studies have already shown that CBD can have an anti-inflammatory and antiseptic effect.

The cannabinoid CBG is less well researched, but it is increasingly becoming the focus of scientific attention. Thus CBG is also attributed anti-inflammatory and antibacterial properties. It is particularly interesting to note that CBG, in combination with other cannabinoids like CBD, could have similar effects to antibiotics. This is shown in a study from 2008, although the exact mechanisms are still unknown.

Results of the study

The mouthwash products contained less than one percent of the cannabinoids CBD and CBG. To compare efficacy, the researchers included two conventional mouthwash products (product A and product B) in the study. Chlorhexidine digluconate 0.2 percent was used as a positive control. The products were tested on plaque samples from 72 adults.

In conclusion, the researchers stated that the CBD and CBG added mouthwash products showed on average a similar bactericidal efficacy as chlorhexidine 0.2 percent in the samples tested.

In contrast, no significant antimicrobial effect was observed for product A, except for a low level of inhibition in nine samples. In the case of product B, no inhibition could be detected in any sample either.

According to the researchers, these results show the potential of CBD and CBG, so that mouthwash and oral care products containing cannabinoids could be the next generation without alcohol and without fluoride.

https://jcannabisresearch.biomedcentral.com/articles/10.1186/s42238-020-00027-z

More than 300 out of 1000 people suffer from recurring tension headaches. About 150 out of every 1000 people complain about migraine headaches and one or two out of every 1000 people complain about cluster headaches, although women are slightly more likely to suffer from chronic headaches than men.

For the majority of people affected, headache attacks mean the interruption of their normal daily routine. In severe cases, headaches can last for several days. Accompanying symptoms such as nausea and vomiting, loss of appetite, hypersensitivity to noise as well as photophobia are additional stress factors.

In acute cases, painkillers and migraine medications can provide relief, but these can sometimes cause considerable side effects.

Various studies suggest that medical cannabis could be a treatment option with fewer side effects. Researchers think that a clinical lack of endocannabinoids might be a cause of different diseases like migraines. It is also known from various reports that medical cannabis and freely available CBD oil for chronic pain can reduce symptoms in acute cases. However, research here is still in its infancy.

Results of the study

That the treatment of chronic headaches could be promising is shown by a small study conducted at Thomas Jefferson University and presented at the virtual annual meeting of the US Headache Society.

48 patients with migraine or other chronic headache types participated in this study. They received treatment with medical cannabis in inhaled or oral form between January and September 2019. A telephone follow-up questionnaire was completed by 28 participants.

The results show that 3 of the 28 participants had stopped cannabis therapy. Before starting therapy, 46.4 percent of the participants took pain medication for at least ten days per month. This rate decreased to 25 percent during cannabis treatment.

In addition, it was reported that the use of cannabis reduced anxiety in 57.1 percent of the participants and 78.6 percent reported an improvement in sleep. On a scale of 10, the participants were asked to rate how useful they felt cannabis therapy was. Here the average score was 5.9 points. 17.9 percent rated the usefulness with a 10.

https://www.medscape.com/viewarticle/933011

The effect of medical cannabis on chronic pain is very well researched. Therefore, it is considered a therapeutic option with few side effects in the treatment of chronic pain. An observational study from Canada proofed that again.

What is the difference between acute and chronic pain?

Acute pain is caused by an injury or damage and is usually limited to the place of origin, such as a broken leg. The intensity of pain depends on the injury. The pain ends when the injury has healed.

We speak of chronic pain if it persists for at least three months. The causes are usually not apparent or the pain persists even though the cause has been eliminated. As a result, an independent disease forms and the brain develops a pain memory.

Treatment of chronic pain

Often the therapy shapes difficultly. Therefore, multimodal therapy, i.e. a combination of different treatments, is commonly used. These include, for example, physical therapies, psychological therapies or complementary procedures such as naturopathic treatment.

In addition to these therapy options, drugs also play an important role in pain medicine. Classic pain medication such as paracetamol, ASS or ibuprofen can relieve pain. However, these drugs can cause serious side effects if taken over a long period of time. Opioids or opiates are also often prescribed for very severe pain, which can not only cause severe side effects but also have a high potential for addiction.

Results of the study

Canadian researchers from Toronto have worked on a prospective observational study with 751 chronic pain patients over a period of 12 months who started medical cannabis treatment. The results show that the patients' pain severity improved after one month of treatment and did not worsen over the 12-month period. Within three months, significant improvements in physical and mental health were also observed. In addition, symptoms such as headaches, anxiety, nausea and fatigue decreased in patients.

Particularly interesting is that patients taking opioid drugs were able to reduce the dose by using medical cannabis.

Insomnia that persists for a long period of time can seriously endanger your health. In a randomized double-blind clinical trial, researchers have now been able to show that treatment with medical cannabis can be effective.

There are multiple causes of chronic sleep disorders. Often, they are triggered by psychological strain, stress and unfavourable sleeping conditions. Various neurological diseases, such as restless legs syndrome or chronic pain, can also make it difficult to fall asleep and prevent people from getting a good night’s sleep. Similarly, the use of medications (e.g. thyroid hormones or antidepressants) and illegal drugs can also cause sleep problems.

Due to the lack of sleep, symptoms such as tiredness during the day, nervousness, inner restlessness as well as concentration and comprehension problems can occur. Sleep disorders can also affect mental stability, resulting in depression or anxiety disorders. The immune system also suffers from sleep disorders.

Treatment of insomnia

The therapy depends on the cause. If psychological problems are present, psychotherapy or cognitive behavioural therapy may be appropriate. Learning relaxation techniques (e.g. autogenic training or meditation) can also be helpful for those affected.

It is also important for those affected to pay attention to a healthy diet and proper sleep hygiene. With the help of special rules of conduct, those affected can promote healthy sleep.

As a rule, sleeping pills are only used in severe cases, as they lose their effectiveness after a short time and also quickly become accustomed. It is also problematic that the sleep disorders reappear when the medication is discontinued.

Medical cannabis as a therapeutic option

In a recent randomized double-blind clinical trial, 23 subjects were treated with medical cannabis for 14 nights. After a one-week rinsing phase, they again received a placebo for 14 nights. The subjects took a single dose of 11.5 milligrams of cannabinoids or a double dose of 23 milligrams of cannabinoids using a sublingual solution.

The results show that the volunteers treated with medical cannabis fell asleep more quickly and also slept significantly longer. The volunteers also reported that their quality of life improved, they felt less stressed and less tired. They also felt better rested after sleep.