Nasus Pharma Receives FDA Clearance for NS002 Clinical Study
News related to:Nasus Pharma Ltd · 1 min read
Nasus Pharma, a clinical-stage pharmaceutical company based in Israel, has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a clinical study of its investigational intranasal epinephrine powder, NS002, for the treatment of anaphylaxis. This development marks a significant step forward in the company’s efforts to provide a needle-free alternative to the current EpiPen® for patients experiencing severe allergic reactions.
According to Brendan O'Grady, Nasus Pharma’s Chief Executive Officer, the FDA clearance is a major milestone for the company. "Our recent Phase 2 study demonstrated that NS002 can achieve the critical 100 pg/mL plasma epinephrine threshold with a median time to peak of 1.69 minutes, compared to 3.47 minutes for EpiPen®. This rapid onset and intranasal administration offer a potentially superior alternative for patients and caregivers."
The clinical study, which is planned for the fourth quarter of 2026, will compare the self-administration of NS002 to administration by a healthcare professional. The company anticipates topline data readout in the first quarter of 2027. O'Grady emphasized the potential impact of NS002 in a market currently dominated by needle-based autoinjectors.
Nasus Pharma, which is advancing innovative intranasal therapies through its proprietary intranasal powder technology platform, is developing NS002 as an intranasal epinephrine treatment for Type I allergic reactions, including anaphylaxis. The company is also leveraging its technology to develop a pipeline of differentiated intranasal product candidates for various therapeutic areas.
The approval of the IND application by the FDA is a significant step toward commercializing NS002.
The company is currently focused on the pivotal study, which is expected to provide critical data to support further development and potential approval of NS002. Nasus Pharma remains committed to advancing its pipeline of innovative treatments and improving patient outcomes in the field of allergy management.