Analgesic Characteristics of NanoBEO Released by an Airless Dispenser for the Control of Agitation in Severe Dementia

Abstract

Chronic pain is one of the most common causes of the need for clinical evaluation, acquiring more importance in the elderly with cognitive impairment. Reduced self-reporting capabilities cause unrelieved pain contributing to the development of agitation. Safe and effective pain treatment can afford the management of agitation without the serious increase in death risk associated with neuroleptics. To this aim, the essential oil of bergamot (BEO), proven by rigorous evidence to have strong preclinical anti-nociceptive and anti-allodynic properties, has been engineered (NanoBEO, patent EP 4003294) to allow randomized, double-blind, placebo-controlled trials (BRAINAID, NCT04321889). The present study: (1) assesses the analgesic effects of a single therapeutic dose of NanoBEO, as supplied by an airless dispenser for clinical translation, in models of inflammatory, neuropathic, and sensitization types of pain relevant to clinic; (2) provides a dose–response analysis of the efficacy of NanoBEO on scratching behavior, a typical behavioral disturbance occurring in dementia. A single therapeutic dose of NanoBEO confirms efficacy following thirty minutes pre-treatment with capsaicin and on the central sensitization phase induced by formalin. Moreover, it has an ID50 of 0.6312 mg and it is efficacious on static and dynamic mechanical allodynia. Altogether, the gathered results strengthen the potential of NanoBEO for clinical management of pain and agitation.

Exploitation of Autophagy Inducers in the Management of Dementia: A Systematic Review

“…The essential oil of bergamot (BEO) is able to enhance both basal and induced autophagy [119], thus proving to be a promising candidate for the improvement of AD-related pathogenesis. Moreover, BEO was subjected to a step-by-step preclinical-to-clinical pathway to obtain proof-of-concept of its efficacy and safety as an engineered, nanotechnological, pharmaceutical form, known as NanoBEO, released by an airless dispenser [120][121][122][123][124][125][126][127][128]. Pain processing is subjected to an important dysfunction during aging [129][130][131], and it is involved in the development of agitation [132,133] and in the reduction of the quality of life [134] of demented patients.…”

Targeting Neuroplasticity for the Management of Pain and Agitation in Alzheimer’s Disease via Bergamot Nanotherapy

“…This nanotechnology delivery system is able to prevent the methodological biases of the clinical trials conducted in aromatherapy up to now. NanoBEO can entrap the smell allowing masking in clinical trials, prevent components from degrading, permit titration of the dose, and can be applied through an airless dispenser affording feasibility of administration [84]. NanoBEO (recently patented (EP 4003294)) retains the antinociceptive and anti-allodynic actions of BEO, to which it adds efficacy to scratching behavior, which is a typical neuropsychiatric symptom [83].…”

Efficacy of Essential Oils in Relieving Cancer Pain: A Systematic Review and Meta-Analysis

“…Preclinical research from our group built the rationale for clinical translation of the essential oil of bergamot (BEO) for continuous administration as aromatherapy, and for transdermal application of an engineered, nanotechnological, pharmaceutical form named NanoBEO released by an airless dispenser [ 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 ]. Since BEO proved its analgesic effectiveness both in inflammatory and in neuropathic pain models, reliable to clinic, it could represent a candidate for the treatment of cancer pain.…”