Nasus Pharma Receives FDA Clearance to Initiate Clinical Study of NS002
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Nasus Pharma said the FDA has cleared its IND application for NS002, an investigational intranasal epinephrine powder for the treatment of anaphylaxis (搜索).
The cleared clinical study will compare self-administration of NS002 with administration by a health care professional as a needle-free alternative to EpiPen.
Nasus plans to start a pivotal study in the fourth quarter of 2026, with topline data expected in the first quarter of 2027.
Nasus Pharma Ltd. (NYSE American: NSRX) has received FDA clearance of its Investigational New Drug application for NS002, an investigational intranasal epinephrine powder for the treatment of anaphylaxis (搜索). The cleared clinical study will evaluate NS002 as a needle-free alternative to EpiPen for patients experiencing anaphylaxis and will compare self-administration with administration by a health care professional.
Beyond the study covered by the IND, Nasus Pharma plans to initiate its pivotal study in the fourth quarter of 2026 and anticipates topline data readout in the first quarter of 2027. Chief Executive Officer Brendan O'Grady said the clearance is a major development milestone and cited the company's recent Phase 2 results, in which NS002 reached the critical 100 pg/mL plasma epinephrine threshold with a median T100 of 1.69 minutes versus 3.47 minutes for EpiPen.
Nasus Pharma is a clinical-stage biopharmaceutical company developing intranasal therapies through a proprietary intranasal powder technology platform. NS002 is its lead product candidate, developed as an intranasal epinephrine treatment for Type I allergic reactions, including anaphylaxis (搜索), and the company is using the same platform to build a pipeline of intranasal candidates across multiple therapeutic areas.
Source: Yahoo Finance