Neffy May be Safe, Effective for Treatment of Urticaria Flares: Daily Dose

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Last week, we reported on findings from a study presented at the 2024 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI).

The study

Researchers conducted a phase 2 study to evaluate the safety and efficacy of a low-dose version of the investigational epinephrine nasal spray neffy^® (ARS-2) in patients with chronic spontaneous urticaria (CSU) treated with chronic medications who were still experiencing flares. The oral presentation given at AAAAI 2024 includes data from 18 adults as of the cut-off date who enrolled in the study and then returned to the clinical site while experiencing a flare.

Participants were randomized to receive a single treatment of ARS-2 (1 mg and 2 mg) and placebo nasal spray “and then crossed over to other treatment during subsequent flare events,” stated investigators.

Researchers assessed efficacy using patient-rated scores (patient-reported pruritus/hive score and visual analog scale for pain) and investigator-rated assessment (extent of urticaria and erythema score) from 5 minutes to 120 minutes after dosing.

The findings

Results showed that both 1 mg and 2 mg doses of ARS-2 resulted in improvement beginning at 5 minutes and persisted for 120 minutes post-dose.

There were no meaningful differences in efficacy between the 2 doses of ARS-2. Investigators noted that statistically significantly improvements (P < .05) between ARS-2 and placebo were observed in all assessments.

In addition, ARS-2 was well-tolerated, with mild-to-moderate adverse events reported in 8 participants, according to the press release. The most common adverse event was nasal discomfort in 5 participants; there were no serious adverse events reported.

Authors' comment

“Urticaria is not only a standalone type I allergy disease, but also represents the most frequent symptom observed during type I allergic reactions including anaphylaxis. The improvement in urticaria symptoms almost immediately after dosing neffy demonstrated its rapid onset of action, and is consistent with the previously reported responses on pharmacodynamic markers of efficacy in as little as one minute after dosing.”

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