Ethicann Pharmaceuticals
Pipeline Products
Ethicann’s business strategy is to leverage its unique formulation and regulatory strategies, developed for the lead MS Spasticity product, to enable launch of three pipeline products into markets worth collectively more than USD $20B (2025 company estimate) – all by 2032. In particular, EPI-004 represents a submarket of a gigantic market (chronic pain in general):
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- EPI-003: Adult Focal Epilepsy
- EPI-004: Chronic pain from cancer
- EPI-005: Chemotherapy-Induced Nausea and Vomiting (CINV)
- CBD-only Zydis ODT formulation (for dose optimization of all pipeline products)
Of unique and particular interest is the notion that patients may be able to ultimately “self-dose” with a CBD-only Zydis ODT, to improve performance of EPI-003 through EPI-005 – see descriptions below. The development timeline, including initial regulatory pathway, is outlined in the table immediately below. The products in this table are referred to as “First Generation Products” – meaning products that can be rapidly moved into various markets with effective execution by Ethicann.
Pipeline & Development Timeline for First Generation Products
Pipeline Drug Products and Regulatory Strategy Summary
EPI-003 - Adult Focal Epilepsy
Focal epilepsy is the most common type of epilepsy in adulthood. Globally, more than 70 million adults are affected by epilepsy, and the market for adult epilepsy treatments is projected to exceed $8 billion by 2030. EPI-003 will be a CBD-only product, like the active pharmaceutical ingredient in Epidiolex®, currently on the market for childhood epilepsy indications. CBD has been shown efficacious in an animal study and an open label human study. FDA Approval will require Phase 2/3 studies and a 505(b)(2) NDA approval.
EPI-004 - Chronic Pain from Cancer
As with EPI-003, Ethicann believes that using its foundational formulation strategy (or a fine-tuned variant) for EPI-004 to address the market for chronic cancer pain has the potential to be a promising approach and could open the door to other pain indications. – a worldwide market exceeding $70 billion. Sativex, clinically tested at a 1:1 THC:CBD ratio, has shown inconsistent results, which could be due to an improper ratio, or perhaps a non-optimal ratio+dose.
EPI-005 - Chemotherapy-Induced Nausea and Vomiting (CINV)
EPI-005 represents a re-formulation of the EPI-002 product for the treatment of CINV. Ethicann plans to deploy a delivery system using the Zydis utilizing a Zydis THC/CBD ODT formulation already developed by Catalent for Ethicann – that will have clinical and safety benefits in treating CINV. In contrast, competing Marinol oral capsules (5 and 10 mg doses) cause a bolus (i.e., a single administration) spike of THC in the blood, which frequently can produce adverse psychogenic effects. Ethicann would only pursue this if the level of efficaciousness were significantly higher than THC alone, given THC is approved and there are six approved generic THC products for this indication.
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CBD Dose Optimization (for Pipeline Products and Future Indications)
Ethicann plans to develop CBD-only Zydis ODT doses, at 15-20 mg of CBD per dose. First will be to perform dose ranging studies in humans, along with each EPI pipeline product, in order to more rapidly determine the optimum therapeutic dose for each indication, thus facilitating dose optimization or use different Zydis CBD dose tablets. In parallel, Ethicann intends to develop the CBD-only Zydis tablet for indications where just CBD might be sufficient to show therapeutic effect. This would include indications such as epilepsy (described above). The liver removes 30-45% of CBD delivered through the stomach. The approach could be used to lower the amounts of CBD (no liver first pass effect) to achieve a desired therapeutic effect, resulting in lowering liver toxicity associated with CBD.