The experimentation with medical cannabis in France, intended for a maximum quota of 3,000 patients, has given rise to an extremely positive response from patients.
According to the first clinical data published since the launch of the experiment in March 2021, 91% of patients say they are satisfied with their treatment.
Despite this positive response, the results should have little or no impact on the potential legalization of medical cannabis in France, the experiment having been extended for a year in order to officially collect more data.
While this is great news for companies providing free products for experimentation, vendors will now have to go through a competitive bidding process to be selected to supply their products for this year. extra, which means there is no guarantee that they will be reselected.
Positive results
According to data published by the National Medicines Safety Agency (ANSM), as of October 18, 2022, 2,204 patients were included in the experiment.
Of the 1,453 still in the study, 792 were being treated for refractory neuropathic pain, 215 for painful spasticity related to multiple sclerosis, 181 for drug-resistant epilepsies, 105 in oncology, 104 in palliative settings and 56 for spasticity.
For indications of treatment-resistant neuropathic pain, results showed that medical cannabis reduced the percentage of patients reporting “severe” or “unbearable” pain from 81% to just 29% after six months.
Just under a third of patients reported a 30% reduction in their pain intensity score after six months, according to the Brief Pain Inventory (BPI) questionnaire, while just over 40 % reported a ‘significant’ or ‘very significant’ reduction in pain at month three, a reduction that continued after six and nine months.
According to data presented by Dr Nicolas Authier, university professor and president of the ANSM scientific committee on medical cannabis, 28% of 739 patients suffering from neuropathic pain abandoned the experience – 49% due to adverse effects. and 41% due to ineffective treatment.
The results were equally positive for palliative care patients, particularly regarding insomnia and pain – 51% reported “significant improvement” and 45% “moderate improvement”.
Across the study, 91% of patients said they were in favor of legalizing medical cannabis in France.
Its impact
Although the results are mostly positive, they should have little impact on the French government’s verdict on the legalization of cannabis for medical use in France.
First of all, as Nathalie Richard, director of the ANSM, pointed out, the objective of this trial was “not to evaluate the effectiveness of medical cannabis, even if clinical data is collected”.
On the contrary, it aims to “assess, in a real situation, the committee’s recommendations in terms of prescribing and dispensing conditions and the adherence of healthcare professionals and patients to these conditions”, only providing safety and efficiency than as a “secondary objective”.
Benjamin-Alexandre Jeanroy, of Paris-based cannabis consultancy Augur Associates, echoed the remarks, adding that it would have been ‘surprising’ if these results were not positive, as these indications were selected specifically. for the trial because medical cannabis had already been ‘assessed as effective’.
While this data is likely to ‘mean very little’ to the entire trial, it should be a significant boon to companies that have been providing free trial products for over a year.
Addressing Marijuana Business Daily in 2020, Dr. Authier said: “It would not be legal to give exclusivity to suppliers, but with hundreds of patients already treated (at the end of the experiment) and doctors accustomed to prescribing their products, c is probably a marketing advantage. »
He added that these companies would also be “first to market” if and when the legalization of medical cannabis was implemented, while these companies would also make “savings” on clinical research.
Companies currently providing the French medical cannabis experience at their own expense include Canadian giant Aurora Cannabis in partnership with Ethypharm, Tilray in partnership with Medipha Sante, Israel’s Panaxia Pharmaceutical in partnership with Neuraxpharm France, Australia’s Little Green Pharma in partnership with Intsel Chimos, and Emmac Life Sciences, which has since been acquired by the American actor Curaleaf.
However, now that the project has been extended for another year, there is no guarantee that these supply agreements will remain in place.
A call for tenders is currently underway and potential suppliers will have to undergo a rigorous verification process before being selected.
The key difference this time around is that providers should be paid for their contributions, with the National Health and Medicines Agency having already asked current providers for a price list to estimate the cost of the extended trial. The call for tenders mentions 14€ per bottle of oil of 10mL and 14€ per bottle of flowers of 10g.
The first round of the experiment is due to end in March this year. Questions remain as to how the following year will be funded.
