BETHESDA, MARYLAND, USA, May 11, 2022 /EINPresswire.com/ — Ethicann Pharmaceuticals Inc. today announced that following a successful animal pharmacokinetic (PK) study, it will begin full scale-up of CGMP manufacturing of its EPI-002 (THC 2 .7mg: CBD 2.5mg) Zydis® sublingual orally disintegrating tablet (ODT) to treat spasticity in multiple sclerosis (MS). EPI-002 utilizes Zydis ODT delivery technology reformulated from an ethanol-based cannabinoid oral spray drug (THC 2.7mg: CBD 2.5mg) that is approved in over 30 countries to treat spasticity in MS. The mouth spray contains 50% ethanol by volume per dose, and some patients have reported that it does not taste good. MS patients need safer drugs, since three other MS drugs have FDA Black Box safety warnings.
Catalent’s proprietary Zydis drug delivery technology is used in more than 20 approved drugs in 60 countries and is protected by a strong international patent portfolio. Zydis EPI-002 ODT dissolves in ~3 seconds without the need for water and is rapidly absorbed through the sublingual mucosa into the bloodstream, providing therapeutic benefit by bypassing the liver, which typically removes 30%-45% of absorbed cannabinoids through the stomach. Hepatic absorption of swallowed and stomach-absorbed cannabinoids can lead to increased liver toxicity. Ethicann intends to use Zydis ODT sublingual technology across its portfolio of cannabinoid-based medicines, to treat chronic pain, post-traumatic stress disorder (PTSD), nausea and vomiting induced by chemotherapy (CINV), opioid addiction and epilepsy.
Ethicann will use the CGMP EPI-002 tablets to perform a human bioequivalence study in 2023, required for its approval in Canada (2024-25), then use the Canadian data in the UK, Germany and the rest of Europe (2025-28), before rolling out EPI-002 in global markets, where alcohol-containing oral spray to treat MS spasticity is approved. In the United States, Ethicann will pursue a 505(b)(2) New Drug Application (NDA) approval pathway. Ethicann is now targeting pharmaceutical companies seeking partnerships, who will obtain regulatory approval for PPE-002 and provide distribution, marketing and sales. This rapid-to-market reformulation strategy avoids the traditional 7-12 years of drug development and requires an investment of $200 million.
Keiretsu Forum has nominated Ethicann to present at the 2022 Angel Capital Association Summit Event in Atlantic City, NJ., May 17-19, 2022. Keiretsu Forum is the largest and most successful community of investors, venture capital and private equity firm accredited in the world with 52 global chapters. The ACA-2020 Summit is the flagship annual networking event for 31 national angel investor groups, involving entrepreneurs and businesses invited to this investor community. By appointing Ethicann, Keiretsu has just completed a positive and thorough due diligence of all aspects of the Ethicann drug reformulation business opportunity, analyzing the strengths of its business strategy, including its global regulatory go-to-market strategy rapid and growth opportunities in MS spasticity disease. markets.
Business Summary: Ethicann (Canada/US) has positioned itself as a profitable pharmaceutical development company, utilizing established multinational partners to source ultra-purified APIs and patented orally disintegrating tablet technology ( ODT) sublingual Zydis. Ethicann is leveraging these partnerships to further formulate and develop cannabinoid-based pharmaceuticals and avoid deploying capital in building and staffing its own facilities. This commercial reformulation strategy coupled with the use of abbreviated regulatory approval pathways in various countries will also be used for the rapid development of its ongoing Zydis-based drugs to address other clinical indications.
Ethicann Pharmaceutical Inc. #