A European pharmaceutical company – which focuses on drugs for the central nervous system (CNS) – has been selected to supply cannabis medicines for France’s landmark pilot study.
Neuraxpharm France announced this week it has been selected as one of winners for the participation in the programme, which has been issued by The French National Agency for the Safety of Medicines and Health Products (ANSM) and is due to start in March 2021.
The company emerged as one of the first European pharmaceutical companies to include medical cannabis products in its portfolio, with a business collaboration starting last year in Germany, the largest cannabis market outside the USA.
As part of its strategic collaboration with Panaxia Labs – Israel’s largest medical cannabis manufacturer – to enter the French market, the companies submitted a joint application for the pilot study.
The programme is based upon strict and demanding compliance specifications, with good cultivation and manufacturing practices, the quality of the drugs and the safety of the distribution channel.
France is the fifth largest pharmaceutical and CNS market in the world and is known to have the strictest regulation in the western world with regard to medical cannabis use.
With a population of about 67 million, recent estimates expect about 700,000 patients in France may be eligible for a medical cannabis prescription.
The prestigious medical cannabis pilot programme will last two years and intends to provide free products to 3,000 patients who meet the criteria.
Selected doctors, nurses and pharmacists participating in this program will undergo special training in registering and issuing medical cannabis prescriptions to patients.
At the end of the study, a decision will be made by the French Authorities regarding a license for the use and sale of medical cannabis products in France.
Along with Neuraxpharm and Panaxia, three of the world’s leading medical cannabis companies were selected as main suppliers for this pilot program, emphasizing Neuraxpharm’s status as a leading player in the European medical cannabis market.
As part of the programme, four finished products were selected that have successfully met the stringent ANSM requirements in relation to finished products.
They include the oral formulations in both the THC and CBD dominant forms together with the balanced THC / CBD formulations.
The list of indications compiled by the ANSM includes diseases such as cancer, certain types of epilepsy, multiple sclerosis, palliative care and pain, where conventional treatments don’t work.
“We are excited to have been awarded and selected to participate in this pilot program for the medical cannabis use in France, a significant market in the fast-growing international medical cannabis sector,” said Dr Jörg-Thomas Dierks, CEO of Neuraxpharm.
“As one of the first pharmaceutical companies to distribute medical cannabis products in Europe, we are ideally positioned, in partnership with Panaxia, to responsibly introduce medical cannabis products to new markets, in line with our corporate mission to offer ground-breaking therapeutic CNS solutions to patients with unmet medical needs.
“We are confident that France will lead the way for other countries to embrace the use of medical cannabis in the coming years.”
Dr Dadi Segal, CEO of Panaxia Israel, added: “Our collaboration with Neuraxpharm positions us as a leading player in the medical cannabis market in France, which is poised to experience accelerated growth. Our extensive combined experience in manufacturing and commercializing processed and advanced cannabis products will provide the program’s patients with state-of-the-art, high-quality medical cannabis products to meet the growing demand for conditions that don’t respond to conventional treatment.”
New global platform offers affordable cannabis education
New online courses are set to offer low-cost, reliable, cannabis education.
A new online education platform is set to tackle stigma around cannabis and open up opportunities for learners across the globe.
Canadian education platform, Edusity, has partnered with the Pharmacology University of Texas-based CHNC, to help learners assess the risks, benefits and business opportunities that come with cannabis legalisation.
Cannabis may be a legal product in Canada, but there are still barriers to learning about the plant, according to Edusity’s founders.
The online education platform enables instructors to post self-directed, video-based courses and to teach live webinars via its virtual classroom. Pharmacology University is another online educational platform which aims to transform the social stigma around medicinal cannabis.
“Education really is the best tool for addressing every area of social change,” said Vishal Shah, co-founder of Edusity.
“In the past, there have been difficulties communicating about legal cannabis education, but with the use of age gate technology and other safeguards, Edusity is helping to create a culture of cannabis literacy that is essential to building a stable, safe industry.”
There are currently 12 low-cost courses from Pharmacology University’s programme available on Edusity.com ranging from cannabis and obesity to cannabis dispensary operations.
Anne Graham, CEO of Pharmacology University, commented: “Pharmacology University is pleased to partner with Edusity on the delivery of our program. As the legalisation of cannabis spreads around the world, there is a need for clear, honest and expertise-driven education about the herb itself, the medical science, the legislation and the business that moves it. We are pleased to have Edusity work with us to make Cannabis education happen.”
71% of CBD consumers see improvement in wellbeing
3,000 people took part in the ‘first of its kind’ study
Results from what is thought to be the largest study to date, show over 70 per cent of CBD consumers saw improvements to their wellbeing.
The study, carried out by Radicle Science, involved over 3,000 participants who were given CBD products to try at home.
The organisation’s Advancing CBD Education and Science (ACES) report, aimed to determine the effectiveness of botanical CBD products.
The randomised controlled trial involved 13 US brands and examined different reasons for taking CBD. This included wellbeing, quality of life, pain, anxiety and sleep quality.
The results revealed that 71 per cent of participants saw an improvement in well-being, with 63 per cent seeing a ‘clinically meaningful improvement in anxiety. A further 61 per cent reported an improvement in sleep quality while 47 per cent said their pain levels were decreased.
Sixty one per cent of participants reported feeling the effects of the CBD within one to four hours of consuming their chosen products.
Speaking with Cannabis Health, Jeff Chen, CEO and co-founder said: “There are studies of American consumers showing that millions are using CBD yet despite that, we still don’t know a lot about it. One of the key reasons is that it was lumped together with cannabis for the longest time so if you wanted to study these products then it was near impossible. What little understanding we have comes mainly from cell and animal studies which shows some amazing things.”
He added: “When we talk about human studies of CBD then there is so little data. The main reasons people are using it is for pain, sleep, stress and anxiety. So our job, as Radicle Science was to generate a body of knowledge and understanding to help consumers.”
The result was a ‘first of its kind’ study providing real-world data on CBD use.
It examined how people used CBD in their own homes rather than a medical setting, how much they use and also what side effects they experienced. To do this, the researchers gathered a diverse pool of participants and paired them with different brands. As the products were mailed to consumers, the study wasn’t limited to those who live near a laboratory and as a result, 3,000 people took part.
Jeff said: “We wanted to involve a variety of different brands with a variety of formulations but we also wanted a diverse pool of participants. This included people from different geographies, ethnicities and demographics to make this as ‘real world’ as possible. We mailed the products to people to take in their own home.”
The success of the CBD was measured with different scientific scales. These findings were assessed through five indices: the World Health Organization (WHO)-5 Well Being Index, the Kemp QOL scale, the Generalised Anxiety Disorder (GAD)-7 scale, the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance SF 8B scale, and the PEG-3 Scale for pain.
Jeff said: “When we were assessing the outcomes, we used measures that were developed by the World Health Organisation or the US National Institue of Health for sleep or pain. We collected all of these validated survey instruments along with tonnes of information on demographics, behaviour and health conditions. we want to understand if there are any variables, whether ethnicity or caffeine consumption may affect usage.”
He added: “As we were working with the brands, we knew exactly what products they were taking and what was in them. Our study made calculating the dosage really easy too, which can be really difficult for consumers. We had participants report how many servings they were using whether that is a gummy or a capsule. The bottle is very clear about what each serving is. We have the chemical analytic results, we can back-calculate the dosage to give us a normalised dosage data.”
Radicle Science report results
The study reported significant improvements in the three main areas people reported using CBD for, such as pain, sleep and anxiety.
Jeff said: “We found that depending on what health outcome you are looking at, 47 to 63 per cent of people experienced not just an improvement but a clinically meaningful one. This means that they are experiencing changes to sleep quality or anxiety that is large enough to make a healthcare provider say it is meaningful. It’s strong enough that it deserves to be further utilised.
Another interesting result was that a majority of people reported the impact within several hours of taking the product. We are still trying to figure out the mechanism of action for CBD. It appears that one of the mechanisms seems to be affecting the serotonin system. If you look at things like SSRIs that are prescribed for anxiety, then they can take several weeks to kick in. What we saw was the onset of effects from CBD happening within several hours.”
Jeff highlighted that the study also examined the participant’s quality of life and wellbeing, which may have seen an improvement due to decreased anxiety and sleep problems. The next phase will examine more of the data points from the study.
He said: “We will be doing a lot more sophisticated biostatistics. The next stage will examine the role that demographic or behavioural characteristics may have played or if they had predictive effects on the outcomes. For example, is the use of caffeine or alcohol made you more or less likely to experience an effect. Did ethnicity mean you were more likely to experience a positive outcome?
“We will look at the different product attributes for the 13 brands to see if a gummy had an advantage over a tincture for example. There is still a lot to be determined that will come in the next wave of analysis.”
Prospect Farms entered some of its products into the ACES study.
Speaking with Cannabis Health, CEO Brad Tipper explained how beneficial the study has been for the brand.
“Our focus has been creating terpene-forward products,” said Brad.
“It makes Prospect Farms products unique in the market compared to a lot of our peers. Our balance products which were included in the ACES study are great for mood and cognition. This was a great opportunity for us to be able to differentiate our view of the market right now. We wanted to be able to show the difference in using quality carriers or terpene blends for health outcomes.”
He added: “One of the biggest areas we hoped Radicle Science would shine a light on is consumer behaviour around dosing. Tinctures are still a very unique concept for the broader audience. We are used to taking a supplement or an over the counter product but we are not used to holding something on our tongues for 30 seconds. Thinking about pipettes and graduated marks can be an intimidating concept.”
CBD report and product changes
Brad highlighted that the insights into dosing have been incredibly valuable for the brand. They have been able to take this into consideration when it comes to their products.
He said: “It has informed a lot of our product development considerations. We are restricted in terms of what we can do under current regulations and we can’t make explicit dosage recommendations. We can allow you to understand how much is in each one of your doses and have direct consultations with the consumer. It has also highlighted a need for potentially higher strength products. This has informed some of our product development.”
British Cannabis products receive breakthrough from the FSA
British Cannabis is dedicated to ensuring the long-term continuity of cannabis-based food supplements in the UK
British Cannabis is the first company to receive confirmation that its cannabis-derived CBD oils and supplements will remain on the UK market, following the implementation of Novel Foods laws.
British Cannabis™, registered as CBD Health Foods Ltd, is delighted to become the first company to receive confirmation from the Food Standards Agency UK (FSA). that its cannabis-derived products will remain on the market.
On Thursday 13th January 2022, the FSA confirmed via emails to British Cannabis CEO, Thomas Whettem, that the evidence submitted in support of 15 dossiers, spanning over 3,000 products “has been checked and is sufficient” and that “the public list will be amended to reflect these changes”.
Meanwhile, it is widely speculated that an as-yet-undetermined number of other products, made by other manufacturers, will be removed from shelves by Trading Standards. This process looks set to begin once the FSA public lists are updated later in 2022.
British Cannabis products
Robert Jappie, the partner at legal firm Ince and preeminent cannabis industry lawyer, remarked at the news: “I’m delighted that British Cannabis has received a positive response from the FSA to their Novel Food submission. Admission of British Cannabis’ products to the compliance registers confirms the company’s position at the forefront of the U.K. CBD industry. Novel Food compliance should now provide a platform for the sector to build on its fantastic success to date.”
Over the course of 18 months and a multi-million-pound investment, British Cannabis, whose brands are stocked across many pharmacies and retailers internationally, have dedicated themselves to ensuring the long-term continuity of all-natural, cannabis-based food supplements in the UK. This is for the reassurance of their own consumers and of all the customers whose brands are powered by British Cannabis.
Making this achievement of particular note is the fact that British Cannabis products are among the few remaining on the market to use ‘100 per cent Cannabis sativa L.”, naturally derived formulas, thus they contain the hundreds of clinically proven plant phytochemicals found in cannabis, whilst also being 0 per cent THC, meaning that they will not cause a “high”. Their food supplements (CBD oils, capsules etc.) are also free from other controlled cannabinoids.
British Cannabis’ CEO, Thomas Whettem, reacted shortly after hearing the news, he said: “Confirmation directly from the Food Standards Agency, that British Cannabis will be the first manufacturer In the world to have cannabis-derived consumer products ratified by the UK government, is yet another monumental breakthrough in our history. For years we have not just pioneered change in this industry but strived to set the bar when it comes to compliance, safety and the simple dedication to excellence we have had since day one.”
British Cannabis’ Managing Director, David Ralson, commented: “This is a huge milestone for our business and the Cannabis industry as a whole. I would firstly like to pay testimony to our staff, who over the past 6 years have endeavoured to make British Cannabis the leading legal-cannabis experts in our sector and this exemplifies our phrase ‘We Know More Because We Do More’.
“We have always believed in wholly cannabis-derived, natural products and obtaining the highest quality standards. This is underpinned by our own retail brands, which to date have received over 4,200 Trustpilot reviews with a 5-Star rating.
“This also paves the way for our trusted white label partners brands, who continue to work with us, to also remain on the UK market. This allows our business and its compliant partners to continue to grow in what is going to be a very exciting year indeed.”
At the time of going to press, the Novel Foods public list has yet to be updated.
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