Cann Group has met the enrolment target for its Phase III clinical trial of low-dose Satipharm CBD capsules for short-term sleep disturbance.
More than 212 patients have been enrolled in the trial since recruitment started in February at centres in Australia and New Zealand.
The company, in conjunction with its trial investigators, is now undertaking a follow-up analysis to determine if the participant numbers are adequate to detect statistical significance and provide a definitive study outcome.
Cann Group anticipates a favourable trial result will support the registration of Satipharm CBD capsules as a Schedule 3, over-the-counter medicine in Australia.
Global healthcare company Haleon previously secured an exclusive evaluation and option agreement with Cann Group for the marketing and sale of over-the-counter Satipharm CBD capsules in Australia.
Cann said the clinical study report is a pivotal milestone in progressing towards a definitive commercial agreement with Haleon.
CEO Peter Crock added: “Recruiting participants for clinical trials has become more difficult following Covid, so we are happy to report that this study is proceeding well, and we look forward to sharing the results in the coming months.”
Cronos has been granted Victorian Government licences to enable the operation of its newly commissioned Melbourne Distribution Centre (MDC) at an undisclosed location.
Fit out of the MDC was completed last week and it is roughly twice the size of the firm’s existing Gold Coast facility to cater for increasing volumes.
It will cover distribution in Victoria, parts of NSW, SA, WA and Tasmania while the remainder of NSW, Queensland, Northern Territory and the ACT will be serviced from the Gold Coast.
Cronos said the move will result in faster delivery times to patients, with some pharmacies in Melbourne receiving orders on the same day. The MDC will now begin to receive orders, with an official opening anticipated in the coming months.
Cronos Australia CEO Rodney Cocks said the facility would “support a significant uplift in medicinal cannabis sales volume through our market-leading CanView platform” and “puts product closer to pharmacies and patients”.
Medicinal cannabis franchisor Releaf Group has announced the expansion of its pharmacy franchise chain with an additional 20 high street pharmacies scheduled to open in 2023, coinciding with the group’s national clinic rollout.
The company is calling for individual pharmacists and pharmacy groups to contact it about opportunities to partner on individual or multiple high-street sites under the Releaf Dispensary banner.
Releaf is already operating in St Kilda, Fortitude Valley, Coolangatta, Noosa and Caloundra and is currently building new clinics and pharmacies in Queensland, Victoria, NSW and SA with plans to “expand into all key high street city, suburban and regional locations across Australia”.
Medicinal cannabis maker Rua Bioscience has exported its first seeds to Australia, believed to be the first legal export of cannabis genetics under New Zealand’s medicinal cannabis scheme.
The seeds will be grown by Cann Group and assessed for their commercial potential with a similar trial run at Rua’s cultivation research and development facility in NZ.
Managing director Anna Stove said: “This seed export demonstrates the value of our relationship with Cann Group as we further establish an end-to-end cultivation and supply chain solution at scale.
“It’s taking time, but we believe weaving the intergenerational plant knowledge of our team with the global cultivation scale of Cann Group will give us a significant competitive advantage.”
Incannex has completed a pre-investigational new drug (IND) application meeting with the US Food and Drug Administration (FDA) regarding its proprietary drug for treating traumatic brain injury (TBI) and concussion.
CBD/isoflurane combination drug IHL-216A is designed to be administered via inhalation soon after head trauma to reduce secondary brain injuries which could lead to neurological deficits, including chronic traumatic encephalopathy resulting from repeated head blows in contact sports.
The FDA provided guidance on the data requirements for opening an IND for the drug, particularly relating to the development of an inhaled product and conducting clinical trials which involve an anaesthetic.
Incannex said the regulator acknowledged TBI as a significant unmet medical need which requires innovative treatment solutions. The firm is currently drafting a follow-up request for additional information on the FDA’s recommendations.