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Pilot clinical and pharmacokinetic study of Δ9-Tetrahydrocannabinol (THC)/Cannabidiol (CBD) nanoparticle oro-buccal spray in patients with advanced cancer experiencing uncontrolled pain.
Clarke, Stephen; Butcher, Belinda E; McLachlan, Andrew J; Henson, Jeremy D; Rutolo, David; Hall, Sean; Vitetta, Luis.
Afiliación
  • Clarke S; Royal North Shore Hospital, St Leonard's, New South Wales, Australia.
  • Butcher BE; Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
  • McLachlan AJ; WriteSource Medical Pty Ltd., Lane Cove, New South Wales, Australia.
  • Henson JD; School of Medical Sciences, University of New South Wales (UNSW), Sydney, New South Wales, Australia.
  • Rutolo D; Sydney Pharmacy School, The University of Sydney, Camperdown, New South Wales, Australia.
  • Hall S; Faculty of Medicine, Prince of Wales Clinical School, University of New South Wales (UNSW), Sydney, New South Wales, Australia.
  • Vitetta L; Medlab Clinical, Alexandria, New South Wales, Australia.
PLoS One ; 17(10): e0270543, 2022.
Article en En | MEDLINE | ID: mdl-36240167
ABSTRACT
This pilot study aimed to assess the safety, tolerability, pharmacokinetics and exploratory analgesic effect of a novel water-soluble oro-buccal nanoparticle spray of a cannabis-based medicine (MDCNS-01) in patients with advanced incurable malignancy with unrelieved pain from opioid analgesic. The study was a non-blinded single arm 2 stage study. Stage I was a single escalating dose (n = 5) [2.5 mg Δ9-THC and 2.5 mg CBD) versus a 3-fold escalated dose. Stage II was an up-titrated dose in patients with advanced cancers and intractable pain (n = 25). During Stage I with an increased cannabis-based medicine dose, maximum observed plasma concentrations of cannabinoids were dose dependant. The water-soluble formulation in the current study resulted in a higher median (min, max) systemic exposure of Δ9-THC than CBD (AUC from 2.5 mg each of Δ9-THC and CBD, was 1.71 ng mL.h-1 (1.1, 6.6) and 0.65 ng mL.h-1 (0.49, 4.1), respectively). During stage II a subgroup of patients diagnosed with breast and prostate cancers with bone metastases, had the highest mean pain score improvement from baseline of 40% (unadjusted) and 33% (adjusted for rescue medication use). For all patients the most reported adverse events were mild or moderate drowsiness affecting 11 (44%) and 4 (6%) patients, respectively, and nausea and vomiting that affected 18 (72%) patients. The water-soluble cannabis-based medicine provided acceptable bioavailability for Δ9-THC/CBD, appeared safe and tolerable in advanced incurable cancers with uncontrolled pain with preliminary evidence of analgesic efficacy.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Dolor Intratable / Cannabidiol / Cannabinoides / Cannabis / Nanopartículas / Neoplasias Límite: Humans / Male Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: Australia

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Dolor Intratable / Cannabidiol / Cannabinoides / Cannabis / Nanopartículas / Neoplasias Límite: Humans / Male Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: Australia