12.03.19
Catalent has entered into a partnership with Ethicann Pharmaceuticals Inc., a pharmaceutical company using cannabinoid oils to formulate prescription drugs. The program will initially focus on using Catalent’s Zydis orally disintegrating tablet technology to develop a new combination pharmaceutical-grade cannabidiol (CBD) and tetrahydrocannabinol (THC) product that, if approved, would trat patients suffering from multiple sclerosis (MS) spasticity.
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 aims to seek approval from the U.S. FDA for this therapeutic candidate 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.
Jonathan Arnold, president of Catalent’s Oral and Specialty Delivery business unit, said, “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. 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 said, “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 more than 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 Zydis Ultra technology, which allows an increased drug load and taste masking to be incorporated into each dose.
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 aims to seek approval from the U.S. FDA for this therapeutic candidate 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.
Jonathan Arnold, president of Catalent’s Oral and Specialty Delivery business unit, said, “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. 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 said, “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 more than 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 Zydis Ultra technology, which allows an increased drug load and taste masking to be incorporated into each dose.
