SCIENTURE HOLDINGS, INC. a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today provided an update on the commercial launch of REZENOPY.
As previously disclosed, Scienture, LLC, a wholly owned subsidiary of Scienture Holdings, Inc. entered into a definitive agreement with Summit Biosciences Inc. (a Kindeva subsidiary) in March 2025, for the exclusive U.S. commercialization rights to REZENOPY (naloxone HCl) Nasal Spray 10 mg, which received FDA approval on April 19, 2024.
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REZENOPY is a high-strength naloxone HCl nasal spray approved by the FDA. The product leverages the proven use of the naloxone hydrochloride and form factor, with increased effectiveness against potent opioids. IQVIA data (MAT September 2025) indicates a total annual sales of $154 million, unit volume of 9.3 million (eaches) for Naloxone in the US market.
“REZENOPY represents a significant advancement in overdose response as the highest-strength naloxone available on the market at 10 mg. It is specifically designed for patients who often require multiple doses of lower-strength naloxone for stabilization in emergency situations,” commented Narasimhan Mani, President and co-CEO of Scienture. “By delivering a higher dose of naloxone, REZENOPY is intended to support opioid receptor antagonism and may help address overdose situations where multiple or potent opioids are involved.”
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“Our manufacturing efforts are firmly on track, and we expect product to be ready as planned in the first quarter of 2026. We anticipate loading REZENOPY into the wholesale channel during Q1 2026, with commercial availability beginning in early Q2 2026,” stated Shankar Hariharan, Executive Chairman and co-CEO of Scienture. “We are excited about this upcoming launch and confident that bringing the highest-strength 10 mg naloxone product to market will address a critical and growing unmet need.”
About REZENOPY
REZENOPY (naloxone HCl) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present.
REZENOPY nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device.
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Source- GlobeNewswire
