The clinical burden of insomnia
Insomnia is broadly defined as difficulty initiating or maintaining sleep.
Insomnia affects 10-30% of the population, with 10-15% of the population classified as chronic.
Insomnia can be a symptom of a range of other disorders, particularly mental health and psychiatric disorders, and can contribute to their onset or exacerbation.
Treating insomnia has been shown to improve depressive symptoms and insomnia may reduce response to depression treatment.
Despite its prevalence, there remains a need for effective pharmaceutical options that support restorative sleep without the next-day impairment.
Positive interim analysis advances Phase III insomnia program
Avecho’s pivotal Phase III trial of its TPM®-enhanced CBD capsule for insomnia has met pre-specified efficacy and safety criteria at interim analysis.
- Trial to continue
Independent review supports continuation to the planned enrolment of 519 participants.
- Safety criteria met
The interim analysis supports the trial’s safety profile to date.
- Program confidence strengthened
The outcome supports continued regulatory, commercial and licensing activity.
No pharmaceutical CBD products are approved for sleep yet, but insomnia remains one of the most prevalent indications targeted globally by medical cannabis and consumer CBD products
Avecho has embarked on a rigorous development program to support the pharmaceutical registration of cannabidiol for the treatment of insomnia. Early phase development is complete, and the product is now being tested in a pivotal Phase III clinical trial to assess its ability to manage insomnia and anxiety.
The trial, targeting 519 patients, is the largest randomized, placebo-controlled study assessing the use of cannabidiol for insomnia conducted to date anywhere in the world.
The study is currently taking place at clinical trial sites around Australia, with locations in Melbourne, Sydney, Brisbane and Perth.