ARS Pharmaceuticals (SPRY) announced that the Pharmaceuticals and Medical Devices Agency, PMDA the Japanese authority responsible for the scientific review of drugs and medical devices, has granted approval for neffy 1 mg and 2 mg doses, for the emergency treatment of allergic reactions in adults and children who weigh greater than 15 kilograms. “We are proud to receive this approval in partnership with Alfresa, which broadens access of neffy and offers the first needle-free epinephrine treatment available in Japan for both adults and children with severe allergies,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. “This represents a significant breakthrough as neffy meets a vital need for patients who may not carry, or hesitate to use, an injectable option for use during emergencies. With its compact design, and extended shelf life, compared to other forms of epinephrine, of 24 months, this advancement empowers patients and caregivers to consistently carry and administer epinephrine at the earliest signs of a severe reaction.”
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