Formulations in the Multimodal

Overview

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Key numbers

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• Guillermo Moreno-Sanz 1*, Alvaro Madiedo 2 , Paula Hernandez 2 , Janosch Kratz 3 ,
• Khiron Life Sciences Spain SL, Madrid, Spain, 2 Khiron Life Sciences SAS, Bogotá, Colombia, 3 Khiron Europe GmbH,
• Frankfurt am Main, Germany, 4 Sovereign Fields SL, San Sebastián, Spain, 5 Zerenia Clinic, London, United Kingdom,
• between May and September 2021 at the Latin American Institute of Neurology
• Guillermo Moreno-Sanz and Nervous System (ILANS-Zerenia) in Bogotá, Colombia. During this period, 2,112
• This article was submitted to were female (76.1%) with an average age of 58.7 years old, and 92.5% (1,955 patients)
• Pharmacological Treatment of Pain, reported some improvement in their primary symptom (p < 0.001). Two monovarietal,
• full-spectrum, cannabis formulations containing either cannabidiol (CBD 30 mg/mL; THC
• < 2 mg/mL) or a balanced composition (THC 12 mg/mL; CBD 14 mg/mL) accounted
• Accepted: 21 February 2022 for more than 99% of all prescriptions (59.5 and 39.8%, respectively). The degree
• effectiveness in the first 4 weeks of treatment. Sex-specific differences were also found in
• Aizpurua-Olaizola O, Brown MRD, overtime. For many patients (71.7%) there were no adverse side effects associated
• to the treatment and those most reported were mild, such as somnolence (13.0%),
• Prescription Patterns and Clinical dizziness (8.1%) and dry mouth (4.2%), which also appeared to fade over time. Our
• doi: 10.3389/fpain.2022.854795 Keywords: cannabis, cannabinoids, oral extracts, chronic pain, sex, Zerenia, Khiron, Colombia
• Cannabis sativa L. is one of the oldest plants cultivated by medicinal cannabis (15). However, the therapeutic use of
• cultures (1). The therapeutic value of cannabis extracts as clinical trials (RCTs) using approved medications such as
• medicine in the mid-19th century. At the beginning of the 20th pain states, and the broad range of CBMPs used in both
• century, cannabis-based medicinal products (CBMPs), including experimental and observational clinical studies (16). Because
• spastic medication (2). The medical use of CBMPs started to (such as Canada or Israel), and expert medical opinion. Many
• decline in the 1930’s, partially due to their marked variability in recent meta-analyses have reached inconsistent conclusions,
• but mainly owing to the passing of the first international efficacy of medicinal cannabis to treat chronic pain (17, 18)
• research into the clinical applications of CBMPs (3). Because highlighting the significant research gaps which exist (19, 20).
• banned the cultivation of cannabis in 1939 (4). Shortly after, generally small and potentially accompanied by the presence
• unique to the cannabis plant, were first identified (5, 6). The thought to be related to the use of CBMPs containing THC,
• (CBD) (8) prompted a medical chemistry campaign that led therefore intriguing that several experts panels have recently
• to the discovery, in the early 1990s, of the endocannabinoid supported the choice of CBD-predominant CBMPs to initiate
• system (ECS), the pharmacological target for cannabinoids in the treatment of patients experiencing chronic pain (25, 26),
• the human body (9). The ECS is a complex physiological an approach clearly aimed at promoting safety over efficacy
• such endocannabinoids (10). The ECS is evolutionarily well- of CBD is minimal (27). In order to assess the translational value
• functions (11), including the regulation of nociception (12). defined, oral cannabis-based formulations on patient-reported
• HIV (THC/dronabinol, Marinol R and Syndros R ), alleviate September of 2021.
• presentations containing cannabinoids, such as cannabis flos of 2021 were reviewed. Study procedures were approved by
• (14). Over the last 4 years, medicinal cannabis in the form Committee of Universidad El Bosque (Act No.012-2021). At
• pharmacy compounding, under the regulations of Decree 613 clinical improvement, as well as the occurrence of any side
• of 2017. These magistral formulations must comply with all effects. First, participants were asked to detail the primary
• specify the content of THC and CBD as active ingredients (4). CBMPs they were currently taking, and if they had experienced
• were then asked to rate (0–100) their current illness score in Gomedisys (Bogotá, Colombia) and analyzed using the Jamovi
• relation to their pre-treatment baseline, with zero being “no free software V2.2.2.
• improvement” and 100 being “total improvement of primary
• (28). Finally, all participants were asked if they had experienced
• CBMPs: anxiety, headache, tachycardia, somnolence, dizziness, A total of 7,874 patients receiving medicinal cannabis as part

Methods (brief)

• sample, our results may over emphasize beneficial responses due recently reported results from a small cohort of chronic pain

Implications

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• Fish — marine, non-predatory (sardines, anchovies, salmon, cod)
• Aluminum

Verification notes

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Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.