A French pioneer in therapeutic cannabis-based medicines, LaFleur created by DelleD proposes the experimentation of a medical device of cannabis flower by vaporization in order to obtain a marketing authorization from the ANSM (National Agency for the Safety of Medicines and Health Products).
DELLED PARTNERS WITH RYAH TO EXPERIMENT A CANNABIS FLOWER INHALER
Article 1 of decree n°2020-1230 of 7 October 2020 authorizes, on an experimental basis, the medical use of cannabis. Within this precise framework, LaFleur submits its candidacy for the experimentation launched by the ANSM on the galenic form “flower by vaporization”. During this experiment, LaFleur wishes to make available its connected vaporizer and its secure car- keys made from imported cannabis flowers.
The supply and distribution of cannabis-based medicines for patients participating in the experiment will be free of charge. LaFleur, via its medical device, will ensure the traceability and reliability of data from the experimentation in order to accompany patients beyond the experimentation in order to reduce the risks of use.
“Our objective is to support the medical profession and patients to meet the current and future needs of research. Indeed, we note a strong demand from the scientific, medical and patient communities for therapeutic cannabis-based medi- caments”. Franck Milone, CEO of DelleD.
AN OPPORTUNITY FOR 3000 PATIENTS REFRACTORY TO CONVENTIONAL TREATMENTS
The decree reserves the medical use of cannabis to clinical situations that are refractory to the indicated and accessible treatments. The list is limited to the following pathologies:
– Neuropathic pain that is refractory to accessible therapies (drug or non-drug); – Certain forms of pharmaco-resistant epilepsy;
– Certain rebellious symptoms in oncology related to cancer or cancer treatment;
– Palliative situations;
– Painful spasticity in multiple sclerosis or other central nervous system pathologies. »
The experiment is scheduled to begin in March 2021 for a period of two years. An estimated 3,000 patients are expected to benefit from this new type of therapy. As such, to ensure and secure the monitoring of these patients during the experiment, the decree provides for “a national electronic monitoring register” (Art. 4 of the decree).
Solene by LaFleur
ABOUT DelleD SAS
At DelleD SAS, we are working to optimize the production of cannabis-based drugs through innovative lighting and artificial intelligence methods. The LaFleur project, created by DelleD, focuses on the development of drugs in partnership with public and private laboratories.