De Motu Cordis (DMC) Applauds ARS Pharma’s FDA Approval of Neffy®, Expanding Patient Options to Needle-Free Epinephrine Delivery and Inspiring Confidence in Our Own Development Efforts.

Brisbane, Queensland

De Motu Cordis (DMC) is pleased to acknowledge and enthusiastically commends the recent U.S. FDA approval of ARS Pharma’s Neffy^®, the first-ever needle-free intranasal epinephrine delivery device for the treatment of anaphylaxis. This groundbreaking approval, announced on August 9, represents a significant step forward in expanding emergency treatment options for patients at risk of severe allergic reactions.

DMC views this approval as a pivotal confirmation of the applicability of the 505(b)(2) regulatory pathway for anaphylaxis treatments. This pathway is especially critical for emergency indications like anaphylaxis, where extensive Phase 3 clinical studies may not be feasible. This development not only strengthens our commitment to advancing our own clinical program, which is designed to realise the potential for more rapid epinephrine absorption through inhalation (IH) administration, but also underscores the importance of providing more patient-friendly alternatives.

“We are pleased to see the approval of a needle-free treatment alternative,” said Professor John Fraser, Founder, CMO, Director at DMC. “The approval of Neffy^® strengthens the motivation for DMC and the broader drug delivery community to continue pushing the boundaries of innovation. We believe that faster epinephrine absorption via inhalation may prove to be a valuable alternative delivery mode not only for anaphylaxis but also for other emergency medical treatments.”

As we continue our development work, the approval of Neffy^® enhances our commitment to providing cutting-edge solutions to improve patient care and safety in critical situations.

“We expect further growth in approvals of improved treatments for anaphylaxis indications over the next 3 to 5 years, primarily driven by continuing innovation in and approvals of improved delivery technologies,” said Peter O’Neill, Chief Executive Officer, DMC. “With these advancements, we expect the addressable patient market to expand by a factor of 2 to 3. Currently, in the U.S. alone, only 8% of individuals with type 1 severe allergic reactions have an active auto-injector prescription, highlighting a significant unmet need.”

DMC is actively developing DMC-IH1, a proprietary drug-device inhaler platform technology specifically designed for emergency medicine in community settings. This platform is being tailored to be easily used by non-medically trained patients and caregivers, providing a more accessible and effective treatment option, particularly in situations where a rapid response is critical.