Cannabidiol (CBD) is a component of cannabis. Avecho's product uses a synthetic form of CBD. CBD is non-psychoactive , meaning it doesn't make you high and doesn't impact your ability to drive a vehicle.
Currently, there is just one CBD product in the world with regulatory approval –Epidiolex, which is sold as an oil (Avecho’s product comes in capsule form).
Epidiolex became the first FDA approved drug for the rare diseases of Dravet and Lennox-Gastaut syndromes in 2018, and its developer, GW Pharma, was subsequently acquired by Jazz Pharmaceuticals for up to US$7.2bn in 2021.
Epidiolex has since been approved in 35 countries. Jazz recently announced Epidiolex revenues of $972M in 2024 with expectations of sales of US$1bn + in 2025. The company also announced that it had recently settled with 10 companies which had filed to sell generic copies of Epidiolex, thus staving off generic competition until the “very late 2030s” or earlier under certain circumstances.
Recommended dosage of Epidiolex in its approved indications is up to 12.5mg/kg twice daily. Thus daily dosage for a 50kg individual would be 1250mg. Epidiolex has an estimated oral bioavailability of 6–14%. At high doses, GI issues are common; these include decreased appetite, diarrhoea and vomiting.
Avecho released preclinical results from independently-conducted animal studies in 2022 which demonstrated not only better absorption of TPM CBD than Epidiolex, but also no symptoms of GI effects, despite the 4 x increase in average CBD absorption.
The Therapeutic Goods Association of Australia (TGA) permits approved CBD products, up to a maximum daily dosage of 150mg, to be sold as either a behind-the-counter OTC product or by prescription.
Avecho's TPM/CBD capsule with enhanced bioavailability is currently being trialled in a randomized, blinded, placebo-controlled Phase 3 study, at doses of 75mg and 150mg, for the treatment of insomnia.
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