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Catalent to partner with Ethicann on new fast-dissolve cannabinoid-based treatment for multiple sclerosis spasticity


4th December 2019
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products, has entered into a partnership with Ethicann Pharmaceuticals Inc, a Calgary-based pharmaceutical company using botanically sourced cannabinoid oils to formulate prescription drugs. The program will initially focus on using Catalent’s proven Zydis orally disintegrating tablet technology to develop a new combination pharmaceutical-grade cannabidiol (CBD) and tetrahydrocannabinol (THC) product that, if approved, would treat patients suffering from multiple sclerosis (MS) spasticity.
 
One of the more common symptoms of MS, muscular spasticity causes feelings of stiffness and a wide range of involuntary muscle spasms in patients. Ethicann will investigate the new Zydis product for the treatment of patients who have shown inadequate response to other symptomatic treatments or who have difficulty tolerating the side effects of other treatments.

Ethicann currently intends to seek approval from the U.S. FDA for this developmental therapeutic product under the “505(b)(2)” regulatory pathway and, for Canada, an expedited approval pathway not requiring extended clinical studies.

Ethicann plans to work with Catalent to leverage the Zydis delivery platform for other cannabinoid-based products as they approach clinical studies, including a combination of THC and CBD for the treatment of chemotherapy-induced nausea and vomiting (CINV), chronic pain, post-traumatic stress disorder (PTSD), and opioid mitigation.

Commenting on the partnership, Jonathan Arnold, President of Catalent’s Oral and Specialty Delivery business unit, stated, “CBDs and THCs are notoriously insoluble and poorly bioavailable so a Zydis sublingual dosage form provides a drug delivery solution by avoiding first pass metabolism.” He added, “Catalent has a proven track record in working with partners to bring new therapies to market quickly and we look forward to collaborating with Ethicann as it prepares for these important studies.”
 
Bruce Mackler, Ph.D., J.D., Ethicann’s President continued, “We believe that Catalent’s Zydis technology could give Ethicann’s pharmaceutical cannabinoids a distinct advantage in the marketplace, allowing patients to ‘self-dose’ if approved to optimize therapeutic effect.”
 
Catalent’s 250,000 sq. ft. site in Swindon, U.K. houses the company’s Zydis development and manufacturing operation, which produces over one billion tablets annually and employs more than 600 people. The company recently began work on extending the facility to allow for the commercialization of its proprietary Zydis Ultra® technology, which allows an increased drug load and taste masking to be incorporated into each dose.