Melbourne-based Entoura Pty Ltd believes the final decision today by the Therapeutic Goods Administration (TGA) to allow the sale at Australian pharmacies of registered low-dose CBD products to be a step in the right direction for broader patient access to safe and quality medication. The significant change from the interim decision with an increase in dose up to 150mg/day is also welcome.
This opens the door for the sale of registered CBD products (with 2% or less other cannabinoids, but only <1% THC) to adults in packets containing up to 4,500mg of CBD, amounting to 30 days supply of the recommended maximum daily dose of 150mg.
PATHWAY TO MARKET
The down-scheduling of low dose CBD from Schedule 4 to a Schedule 3 drug paves the way for Entoura to apply for ARTG registration of all three of its GMP-compliant products to be available over the counter. These products are CBD products (with 2% or less other cannabinoids with <1% THC) in pack sizes containing up to 4500mg of CBD, amounting to 30 days supply of the recommended maximum daily dose of 150mg, thus meeting the TGA and ARTG’s S3 dose and pack size criteria.
Even though the implementation date has also been brought forward to February 2021, it is important for consumers to understand that the S3 product registration pathway can be lengthy. The products need to be demonstrated to be safe, of pharmaceutical grade quality manufactured in a GMP facility, and effective. While the GMP compliance of Entoura’s products will help the submission process, most S3 products may not be on Australian pharmacy shelves until 2022.
PRODUCT INNOVATION AND RESEARCH
Nonetheless, the requirement of efficacy data even at the proposed dose of 150mg/day will likely result in further clinical research in the area of low dose CBD medicines. This is another welcome move, given Entoura’s strong emphasis on research.
Entoura is currently looking at innovation and will be mindful of the S3 space in new product development activities. The company has engaged in the Clinical Trial program with their full range of products, including the S3 candidate products, and will work to ensure that future activity in this program covers the needed data for product registration.
- Entoura embraces TGA’s final decision to legalise over-the-counter low dose CBD
- Down-scheduling helps increase patient access to safe and quality CBD medication but chronically ill patients may still require prescription medicinal cannabis
- Entoura currently has three products in the market that fit the S3 profile from a dose/pack size perspective
- Entoura is planning to file for ARTG registration, with likely availability over the counter in 2022
- GMP compliance of these products may speed up the ARTG submission
- Entoura will encompass S3 products in future product development activities
- Our Clinical Trial program will help gather required ARTG data
- Entoura’s three eligible products also satisfy the final decision requirement of only oral, oral mucosal and sublingual formulations – no vaping or topicals
Clare Barker, General Manager Entoura says : “The registration requirements for S3 medicines are detailed and Entoura is working towards ensuring we have all the required clinical data to support the submission, including information from our current clinical trial with Applied Cannabis Research. With the submission requirements and TGA review timelines, there are unlikely to be S3 product options available for Australian consumers until 2022.”
Professor Ian Brighthope, founding president of the Australasian College of Nutritional and Environmental Medicine (ACNEM) says: “The down-scheduling of CBD to over-the-counter status is welcome but is unlikely to usher in radical change to medicinal cannabis access in Australia. Chronically and seriously ill patients will still require prescription medicinal cannabis, as S3 low dose products are generally for non-chronic or self-limiting conditions, as reflected in the 150mg daily dosing and maximum bottle size for products.”
Any doctors or specialists requiring further information about products can register for the Entoura Cannabis Support Portal .
Available for interview:
- Clare Barker , GM Entoura Pty Ltd
- Prof Ian Brighthope, ACNEM Founding President
For Media Enquiries: AJD Media on firstname.lastname@example.org or call 0422238809
Australian medicinal cannabis company Entoura was established by Professor Ian Brighthope, who over 40 years ago founded Nutrition Care Pharmaceuticals , a leader in the formulation and manufacture of therapeutic nutraceutical medicines. Entoura is committed to the development of high-quality innovative therapeutics that are supported by outstanding research programs, validated with clinical evidence and disseminated via exceptional education programs.
Entoura has recently launched a groundbreaking new online tool for doctors to apply for DVA patients’ funding of medicinal cannabis.
Entoura is also currently conducting two research projects:
- Anxiety Disorders and PTSD
- Sleep Study
Interested parties can find out more information here.
Entoura is always happy to answer questions: Contact Us