Based on the research carried out by Prof. Tullio Scrimali, founder and director of the Cannabis Medica ALETEIA (www.cannabismedicaaleteia.it), the prospect of using a cannabidiol product in Psychiatry, such as NegEnt (registered trademark), appears promising.
The only cannabidiol-based medication currently registered in the United States and in the European Union is Epidiolex, with the only therapeutic indication being Gastaux-Lennox epilepsy syndrome.
The registration of NegEnt as a cannabidiol medication, with a tranquilising, anxiolytic and antipsychotic profile, will involve a fair amount of time and substantial economic investments.
In the meantime, in order to make NegEnt available to patients as soon as possible and at a low cost, Professor Scrimali decided to introduce the product as an Aromatherapy preparation in the shortest possible time and to begin, immediately afterwards, the path for its registration in Europe as a herbal medicine.
Sales are carried out directly via e-commerce. This operational choice makes possible to make NegEnt available at a low cost and, therefore, allowing the clinical trial to be extended, which is currently facing difficulties because of the extremely high costs of the galenic preparations. In this regard, we should note that Sicily constitutes a geographical area with optimal climatic characteristics for the cultivation of Cannabis sativa.
Herbal Neurocare proposes, therefore, to implement a NegEnt production project in the medium term, where the entire supply chain is located in Sicily and, in particular, in Ennese, one of the most economically depressed areas of Europe.
To achieve this ambitious goal, in a short time, but in scientifically based terms, moving in a dynamic of strict legality and good commercial practices, as well as medical ethics, and within the tight-knit current Italian and European legal framework, the relative themes related to the production and trade of NegEnt as a "Natural Phytoproduct for Aromatherapy" have been identified, with the aim of introducing it as soon as possible in the autumn of 2019, on the Italian, European and global markets.
But what exactly are Aromatherapy preparations? These are basically essential oils, produced from plants rich in essences. Cannabidiol, extracted from the "legal" Cannabis sativa, with a low THC content, is one of these essential oils, extracted from the dried inflorescences of the female hemp plant.
The sale of essential oils in Italy is currently not regulated. EU institutions and the Italian government, in fact, have not yet defined a regulatory framework that confers legal recognition on bio-natural disciplines. In particular, in Italy, we are still at the draft regulatory level such as the latest bill of May 3rd, 2010 (no.2152) regarding the regulation of the naturopath, namely a professional who uses natural remedies.
Natural products are, however, regulated in Italy, which limits the products that can be sold by herbalists to those with little or no toxicity. From this point of view, cannabidiol is a very safe substance as there is an enormous amount of literature that shows its absolute tolerability, even at very high dosages.
Furthermore, the use of pure CBD in aromatherapy makes it possible to exclude the presence of any contaminant with characteristics that are toxic or harmful to human health.