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The legalization of recreational marijuana use has broadly increased the availability of cannabis and the number of cannabis users. In the latest information (2019) compiled bySAMHSA, an estimated 31.5m individuals over 12 in the US used cannabis in the last month. These rates are growing at approximately 10% per year, with the largest growth in use by adults over 26 (19% growth in 2018-2019). However, growth in the sales of edible cannabis products hasoutpacedeven these trends: sales of edible expanded 60% from 2019 to 2020 for an estimated market of $1.23 billion.

This rise in edible cannabis has had several unintended consequences, in particular a rise in the number of cases of accidental over ingestion. Edibles contain a range of different THC concentrations, including many with several times the average dose for an adult. Also the onset of drug effects for edibles is much longer than for smoked or vaped cannabis products, and this can lead to individuals overconsuming these products under the impression that they have under-dosed.

There is evidence that these cases of over-consumption have lead to an increase in the rates of acute cannabinoid intoxication (ACI) requiring medical attention. Poison control centers have documented adramaticincrease in the number of reports involving edible cannabis, rising from 8.4% to 31.2% of reports from 2017 to 2019.

This report also documented the increased risk to children from edibles, with these products making up 48% of reports involving children under 10, despite being only 11.1% of cannabissalesnationwide. The availability of gummies, cookies, brownies, and other sweets likely exacerbates the issue. ACI is a medical emergency in children and isassociatedwith encephalopathy, coma, severe respiratory depression requiringventilation, and evendeath.

Anebulo Pharmaceuticals developing a treatment to help address the issues of ACI from edibles and other products. The company’s lead compound ANEB-001 is an antagonist of the CB1 receptor responsible for the effects of cannabis and THC intoxication. ANEB-001 works by binding to and blocking these receptors from engaging THC and other cannabinoids (eg. synthetics like K2 or Spice).

The hope is that this could be used as a quick treatment to alleviate the symptoms and risks of ACI when these patients arrive in the emergency room. There were over 1.7 million estimatedER visitsassociated with cannabis in 2018, or over 1% of all visits to the ER during that year.

The drug has already been tested in Phase I clinical studies and shown to be safe across a range of doses. The company is planning on initiation a Phase II clinical study in cannabis smokers in 2021.