Biological bases for a possible effect of cannabidiol in Parkinson's disease

Current pharmacotherapy of Parkinson's disease (PD) is palliative and unable to modify the progression of neurodegeneration. Treatments that can improve patients' quality of life with fewer side effects are needed, but not yet available. Cannabidiol (CBD), the major non-psychotomimetic constituent of cannabis, has received considerable research attention in the last decade. In this context, we aimed to critically review the literature on potential therapeutic effects of CBD in PD and discuss clinical and preclinical evidence supporting the putative neuroprotective mechanisms of CBD. We searched MEDLINE (via PubMed) for indexed articles published in English from inception to 2019. The following keywords were used: cannabis; cannabidiol and neuroprotection; endocannabinoids and basal ganglia; Parkinson's animal models; Parkinson's history; Parkinson's and cannabidiol. Few studies addressed the biological bases for the purported effects of CBD on PD. Six preclinical studies showed neuroprotective effects, while three targeted the antidyskinetic effects of CBD. Three human studies have tested CBD in patients with PD: an open-label study, a case series, and a randomized controlled trial. These studies reported therapeutic effects of CBD on non-motor symptoms. Additional research is needed to elucidate the potential effectiveness of CBD in PD and the underlying mechanisms involved.

Biological bases for a possible effect of cannabidiol in Parkinson's disease.

Current pharmacotherapy of Parkinson's disease (PD) is palliative and unable to modify the progression of neurodegeneration. Treatments that can improve patients' quality of life with fewer side effects are needed, but not yet available. Cannabidiol (CBD), the major non-psychotomimetic constituent of cannabis, has received considerable research attention in the last decade. In this context, we aimed to critically review the literature on potential therapeutic effects of CBD in PD and discuss clinical and preclinical evidence supporting the putative neuroprotective mechanisms of CBD. We searched MEDLINE (via PubMed) for indexed articles published in English from inception to 2019. The following keywords were used: cannabis; cannabidiol and neuroprotection; endocannabinoids and basal ganglia; Parkinson's animal models; Parkinson's history; Parkinson's and cannabidiol. Few studies addressed the biological bases for the purported effects of CBD on PD. Six preclinical studies showed neuroprotective effects, while three targeted the antidyskinetic effects of CBD. Three human studies have tested CBD in patients with PD: an open-label study, a case series, and a randomized controlled trial. These studies reported therapeutic effects of CBD on non-motor symptoms. Additional research is needed to elucidate the potential effectiveness of CBD in PD and the underlying mechanisms involved.

Desafios do desenvolvimento dos dossiês de registro de medicamentos fitoterápicos / Challenges in developing herbal medicine dossiers for registration at anvisa (brazilian health surveillance agency)

Os benefícios da utilização de plantas medicinais são amplamente discutidos no âmbito acadêmico por meio de pesquisa básica e pela população em geral, baseado no ainda presente uso tradicional. Porém, é evidente a baixa demanda por registro no órgão sanitário competente (ANVISA) de produtos considerados medicamentos fitoterápicos ou produto tradicional fitoterápico. A ANVISA tem implementado requisitos visando a garantir qualidade, segurança e eficácia desses produtos, a luz do que se exige aos medicamentos classificados como sintéticos. Nesta revisão, aspectos relacionados à pesquisa e desenvolvimento, em linhas gerais, de um medicamento fitoterápico são relacionados com o arcabouço regulatório que normatiza o registro de tais produtos. Cada etapa de desenvolvimento relaciona-se a uma normativa em específico, de tal forma, que a execução de qualquer experimento de forma diversa da preconizada, impossibilita sua utilização na documentação de registro do produto. Este link é essencial para que se obtenha resultados satisfatórios no sentido de viabilizar-se o registro e futura comercialização dos produtos desenvolvidos. O aproveitamento dos estudos realizados, a qualidade da documentação gerada e a aderência aos requisitos regulatórios, permitem a submissão de dossiês de registro, que uma vez analisados, serão aprovados pelo órgão competente. A aplicabilidade das políticas de atenção básica a saúde que preconizam a utilização de fitoterápicos, depende do correto desenvolvimento destes produtos, aprovação do órgão regulador para que somente então a população possa ter acesso.

The benefits of using medicinal plants are widely discussed in the academic field through basic research and the general population, based on the still present traditional use. However, the low demand for registration of products considered herbal medicine or traditional herbal medicine is clear in the competent health surveillance agency (ANVISA). ANVISA has implemented requirements aiming to ensure the quality, safety and efficacy of these products in light of what is required for drugs classified as synthetic. In this review, general aspects related to research and development of herbal medicines are related to the regulatory framework that regulates the registration of such products. Each development stage relates to a specific normative, so that the implementation of any form differing from the proposed experiment precludes its use in product registration documentation. This link is essential in order to obtain satisfactory results to enable the registration and future commercialization of the developed products. The use of studies, the quality of the generated documentation and the adherence to regulatory requirements allow the submission of registration dossiers, which, once analyzed, are approved by the competent body. The applicability of primary care health policies that advocate for the use of herbal medicines depends on the correct development of these products, and approval by the regulatory entity, and only then, the general population can have access to such medicine.