06th May 2020 – Neurelis, Inc. issued an announcement, which is summarized as follows：
– ARS Pharmaceuticals’ lead product, ARS-1 (epinephrine nasal spray) to treat severe allergic reactions, has previously been granted Fast Track designation by the U.S. Food and Drug Administration (FDA)
– Neurelis’ lead product, VALTOCO (diazepam nasal spray), approved by the FDA for seizure cluster rescue, also utilizes Intravail as a key component of its formulation
– New data further highlight the permeation enhancement potency of Intravail for both small and large molecules
Neurelis, Inc., today announced that the American Academy of Allergy, Asthma & Immunology (AAAAI) presented promising results for ARS Pharmaceuticals’ lead asset, ARS-1, a 1-mg intranasal epinephrine product utilizing the Intravail technology. The abstracts released by AAAAI show that ARS-1 results in bioequivalent exposure to epinephrine injection given once and twice, as well as results in a more rapid absorption and onset of hemodynamic effects. ARS-1 is being investigated as a treatment for patients with severe allergic reactions (including anaphylaxis) to food, medications and insect bites that could lead to life-threatening anaphylaxis.
VALTOCO (diazepam nasal spray), Neurelis’ lead product, also leverages Intravail as a key component of its formulation. VALTOCO was granted approval by the FDA on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
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