Medlab Clinical Developing New Buccal Spray for Chronic Cancer Pain Relief

PainRelief.com Interview with:
Dr.  Jeremy Henson
Director of Medical Affairs
Medlab Clinical Ltd

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: THC and CBD combination medicines have the potential to provide a non-opioid option for chronic pain that does not have the GIT or respiratory adverse reactions of opioids and allows better cognitive functioning.

Delivery across the oro-buccal membrane appears to be best method of administration of cannabinoids for chronic pain. Oro-buccal delivery has pharmacokinetics appropriate for 6-8 hourly maintenance dosing and avoids first pass metabolism and the slow erratic onset of ingestion; and the high serum THC peaks, frequent redosing and toxic oxidation products of vaping.

The problems with using a 50% ethanol vehicle to deliver cannabinoids across the oro-buccal membrane include local irritation, incomplete absorption and significant systemic ethanol levels. These issues could be solved by using a micellular nanoparticle to solubilise the cannabinoids and deliver them across the oro-buccal mucous membrane.

This study was a first in human study of a micellular nanoparticle formulation of 1:1 THC and CBD delivered as an oro-buccal spray for chronic cancer pain.

PainRelief.com: What should readers take away from your report?

Response: The micellular formulation of THC and CBD in NanBisTM demonstrated a good safety and tolerability profile over the two weeks of use in advanced cancer patients and did not cause the local irritation that has been reported for a 50% ethanol formulation. The micellular formulation provided twice the bioavailability reported for a 50% ethanol formulation (based on the single dose pharmacokinetics and the maintenance dose required for same analgesic effect).

PainRelief.com: What recommendations do you have for future research as a result of this work?

Response: The efficacy of NanBisTM for chronic pain needs to be demonstrated in randomised controlled clinical trials. Because the initial patient group will be cancer patients this will be challenging.

Cancer patients in general are a heterogeneous group and mostly have a nociceptive type of pain from ongoing organ destruction. A homogeneous cancer patient cohort with primarily pain hypersensitivity symptoms (neuropathic-like pain symptoms) should be used for further studies as this seems to be the pain type for which THC-CBD combinations are most effective.  

CBD can inhibit opioid metabolism, which emphasises the need to for clinical trials that demonstrate the analgesic effectiveness of NanaBisTM independent of opioids. Ethically this is problematic in advanced cancer patients; however, randomised withdrawal designs have been used successfully for this purpose.

Disclosures: I am employed part-time by Medlab Clinical (Australia), the sponsor of NanaBisTM.

Citation:

Pain Week 2021 Poster #34: Number 34 – A THC/CBD oro-buccal spray with improved mucosal absorption and preliminary efficacy for chronic pain.

https://www.painweek.org/

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