Brisbane-based company De Motu Cordis, which is developing products to enable more rapid epinephrine absorption, has "enthusiastically" welcomed the US FDA's approval ARS Pharma's Neffy.
The FDA recently approved ARS Pharma's first-ever needle-free intranasal epinephrine delivery device for the treatment of anaphylaxis.
De Motu Cordis said the approval of Neffy represents a significant step forward in expanding emergency treatment options for patients at risk of severe allergic reactions.
The Australian company is actively developing DMC-IH1, a proprietary drug-device inhaler platform technology specifically designed for emergency medicine in community settings. It is being tailored to be easily used by non-medically trained patients and caregivers, providing a more accessible and effective treatment option.
It said approval confirmed the applicability of the FDA's 505(b)(2) regulatory pathway for anaphylaxis treatments.
This pathway allows applicants to leverage existing public literature or the regulator's prior safety and effectiveness findings for an approved drug. It often applies to changes in already approved drugs or the introduction of a new chemical entity without a right of reference to previous studies.
De Motu Cordis said this pathway is critical for anaphylaxis products, where extensive Phase 3 clinical studies may not be feasible.
“We are pleased to see the approval of a needle-free treatment alternative,” said Professor John Fraser, the founder and chief medical officer of De Motu Cordis.
“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.”
“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, the CEO of De Motu Cordis. “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."