In:
PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 10 ( 2022-10-14), p. e0270543-
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.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0270543
DOI:
10.1371/journal.pone.0270543.g001
DOI:
10.1371/journal.pone.0270543.g002
DOI:
10.1371/journal.pone.0270543.g003
DOI:
10.1371/journal.pone.0270543.g004
DOI:
10.1371/journal.pone.0270543.g005
DOI:
10.1371/journal.pone.0270543.g006
DOI:
10.1371/journal.pone.0270543.t001
DOI:
10.1371/journal.pone.0270543.t002
DOI:
10.1371/journal.pone.0270543.t003
DOI:
10.1371/journal.pone.0270543.t004
DOI:
10.1371/journal.pone.0270543.t005
DOI:
10.1371/journal.pone.0270543.s001
DOI:
10.1371/journal.pone.0270543.s002
DOI:
10.1371/journal.pone.0270543.s003
DOI:
10.1371/journal.pone.0270543.s004
DOI:
10.1371/journal.pone.0270543.s005
DOI:
10.1371/journal.pone.0270543.s006
DOI:
10.1371/journal.pone.0270543.s007
DOI:
10.1371/journal.pone.0270543.s008
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2022
detail.hit.zdb_id:
2267670-3
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