AusCann set to launch cannabinoid medicine for chronic pain

Medical cannabis company AusCann has announced the successful completion of pilot production of its capsule-based cannabinoid medicine for sufferers of chronic and neuropathic pain, enabling the company to move into commercialised manufacture.

The capsules will target the estimated 1.9 million Australians who suffer chronic neuropathic pain through the TGA’s Special Access Scheme, and will also be available for supply internationally and for clinical studies towards registration on the Australian Register of Therapeutic Goods. While other medicinal cannabis products — including oral liquids, oral sprays, soft-shell gelatin capsules containing cannabinoids dissolved in oils, and dried material or extracts — suffer from poor stability of the active cannabinoids, AusCann’s hard-shell capsules provide consistent and stable dosage of the active ingredients.

US-based company PCI Pharma, which provides outsourced drug development and manufacturing services to the healthcare sector, has been appointed to produce the solid hard-shell capsules in time for release to patients in the first half of 2019. It will manufacture the hard-shell capsules at its manufacturing facilities in Australia, where it is licensed by the TGA.

“AusCann elected to work with PCI Pharma due to their significant experience in providing manufacturing services of solid dose potent products to high standards of safety and quality,” said AusCann Managing Director Elaine Darby. “This allows AusCann to bring its first hard shell capsules into the chronic pain market as quickly as possible, while continuing to focus on the development of our second-generation cannabinoid pharmaceutical products.”

The manufacturing work by PCI Pharma complements AusCann’s research and development site it proposes to establish in Western Australia in early 2019. The WA site will be focused on the development of AusCann’s cannabinoid pharmaceutical product pipeline and will encompass cultivation, extraction, new product development and manufacturing activities.

Strain improvement cultivation at the WA site is expected to commence in H1 2019 with genetics provided by Canopy Growth. These genetics have already cleared quarantine and are available for collection and planting. Material from this cultivation will also be used in AusCann’s own manufacturing R&D work.

Cultivation activities will be overseen by AusCann’s master grower, Canadian Luke Pigeau, which has over 10 years cannabis cultivation experience. Development, extraction and manufacturing will be overseen by AusCann’s pharmaceutical team, headed by Dr Paul MacLeman, which has over 80 years’ combined experience in the pharmaceutical sector.

AusCann has lodged a patent in respect to the intellectual property of the dose form it has developed. The company has also ensured that international Good Manufacturing Practice standards were followed in the design and manufacturing process, enabling export to key overseas markets.

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