REZENOPY®: The Most Potent Naloxone Nasal Spray Enters the U.S. Market

Scienture Holdings Inc. (NASDAQ: SCNX) has secured exclusive U.S. commercial rights for REZENOPY® (naloxone HCl) Nasal Spray 10mg through its subsidiary, Scienture LLC. The partnership between Summit Biosciences Inc. under Kindeva Drug Delivery L.P. and Scienture includes product manufacturing and supplying by Kindeva alongside Scienture’s responsibility for sales, marketing, and distribution activities.

REZENOPY® represents the strongest available version of naloxone HCl because it offers superior potency and is designed for effective opioid overdose reversal. Scienture adds REZENOPY® to its product collection to fulfill its objective of providing healthcare improvements through novel therapeutic choices. The strategic partnership has been crucial in combating opioids and making lifesaving medicine available to the public while collaborating with medical experts and government agencies for both awareness campaigns and educational initiatives.

Nasal naloxone sprays serve first responders and medical providers as essential tools due to their proven effectiveness, easy design, and broad availability. IQVIA data indicates the U.S. naloxone market recorded $189 million in yearly sales and sold 10 million units during the MAT December 2024 period.

President of Scienture, Dr. Narasimhan Mani, stated that this collaboration between Scienture and Kindeva demonstrates the company’s plan to confront the opioid epidemic. CEO Dr. Shankar Hariharan emphasized the necessity of public health agencies and community group collaboration to increase accelifesavingsaving solutions. Kindeva CEO Milton Boyer showed strong excitement about releasing the nasal spray because he saw it could decrease opioid overdose deaths across America.

REZENOPY® functions as an opioid antagonist to treat suspected opioid overdoses where patients display signs of central nervous system and respiratory depression. Provided as a nasal administration product, the product exists in a carton pack containing two single-use spray units.

Administration: For intranasal use only. It is essential to seek immediate medical attention following intranasal use. Administer a second dose if there is no response after 2-3 minutes or when respiratory depression reappears.

Continuous patient monitoring is necessary due to the risk of recurrent respiratory and CNS depression. Effectiveness may be reduced against partial or mixed opioid agonists, such as buprenorphine. The medication has the capacity to initiate opioid withdrawal symptoms, and they tend to be severe, especially when appearing in newborns.

The most common side effects are upper abdominal pain coupled with cold symptoms and changes in taste perception. The medication needs to be stored between 2°C and 25°C and protected from excessive heat and freezing.

The pharmaceutical company Scienture Holdings, Inc. operates through its subsidiaries Scienture, LLC and Integra Pharma Solutions, LLC, to develop and distribute specialty pharmaceutical products. Scienture manages branded pharmaceuticals, and Integra meets the pharmaceutical demands of clinics, hospitals, and retail pharmacies.

Kindeva Drug Delivery L.P. operates as a global contract development and manufacturing organization (CDMO) dedicated to developing sterile injectable, nasal pulmonary, and transdermal drug delivery systems. Through ongoing investments, the company obtains high-end technological systems that strengthen pharmaceutical production alongside sustainability-based activities.

References: Scienture Holdings, Inc. SCIENTURE to commercially launch REZENOPlifesavingsaving opioid overdose emergency treatment through collaboration with Kindeva Drug Delivery L.P. [March 6, 2025]. https://www.globenewswire.com/news-release/2025/03/06/3038102/0/en/SCIENTURE-to-commercially-launch-REZENOPY-a-life-saving-opioid-overdose-emergency-treatment-through-a-collaboration-with-KINDEVA-DRUG-DELIVERY-L-P.html

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