Scienture Holdings Inc. (SCNX) announced an update on the upcoming commercial launch of REZENOPY, its FDA-approved 10 mg naloxone HCI nasal spray for emergency treatment of opioid overdose.
Opioid overdose remains a critical public health challenge, often requiring multiple doses of lower-strength naloxone for stabilization.
REZENOPY (naloxone HCl) is administered intranasally via a single-use spray device. Each carton contains two blister packages, enabling immediate emergency use. The therapy is intended for adult and pediatric patients experiencing respiratory or central nervous system depression due to suspected opioid overdose.
The product had received FDA approval in April 2024, and Scienture has secured exclusive U.S. commercialization rights through an agreement with Summit Biosciences, a Kindeva subsidiary.
Manufacturing remains on track, with wholesale channel loading expected in the first quarter of 2026 and commercial availability beginning in the early second quarter of 2026.
IQVIA data shows the U.S. naloxone market at approximately $154 million annually, with unit volume of 9.3 million annually. Scienture emphasized that REZENOPY's higher strength addresses a growing unmet need in overdose response.
SCNX has traded between $0.46 and $7.68 over the past year. The stock closed yesterday's trading at $0.52, down 8.60%.
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