MGC Pharma’s CannEpil+ epilepsy treatment has been approved for import by the UK’s Medicines and Healthcare products Regulatory Agency.
It is the first time that an epilepsy treatment currently in a clinical trial process, and containing THC, has been approved for import into the UK.
CannEpil+ will be made available for free on compassionate grounds to 10 patients with refractory epilepsy for six months. Their treatment will be monitored as part of an observational trial using a data collection app to provide real-time insights into its efficacy.
Meanwhile, the company’s proprietary nutraceutical food supplement Artemic, which has shown effectiveness in improving the clinical recovery of patients with mild COVID-19, has been approved for sale in Germany, opening it up to the EU and other international markets.
AusCann has engaged US consultancy Knoell Animal Health to advise on its clinical program and US regulatory strategy for veterinary drug candidate CPAT-01.
CPAT-01 is a Phase 2 standardised pharmaceutical derived from THC and CBD extracts, in development for US Food and Drug Administration, Centre for Veterinary Medicine (FDA-CVM) approval for pain and inflammation in dogs.
The move comes ahead of the company’s pre-submission conference meeting with the FDA-CVM.
Dr Laura Treml is AusCann’s technical lead for the engagement, bringing more than 20 years’ experience in companion animal practice and veterinary drug development for US and EU regulatory approvals.
The veterinary pain and inflammation market is worth over US$1 billion globally. AusCann told the ASX there is an unmet need for safe and viable treatment options for dogs suffering from painful conditions.
Creso Pharma has secured two new purchase orders (POs) from Swiss-based health products distributor MHG GmbH for its cannaQIX range worth around A$338k.
The POs, for Creso’s cannaQIX hemp seed oil lozenges and cannaQIX 50 lozenges, will see the products sold throughout Europe via MHG’s extensive sales network. It has more than 3,500 international points of sale.
The companies are also in discussion about additional purchases of Creso’s animal health products.
Canopy Growth has launched its first CBD vape in the US to capitalise on a market valued at US$15 billion last year.
The company’s ‘Whisl’ pods will be available in three varieties, targeting mood management at different times of the day. Each will contain 200mg of purified CBD, sourced locally.
The product will be available in more than 3,000 Circle K convenience stores in 21 states from the start of October.