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SCIENTURE Provides Update on the Commercial Launch of REZENOPY®, the Highest Strength Naloxone HCl Life-Saving Opioid Overdose Emergency Treatment Approved by the FDA

1. SCNX enters naloxone market with REZENOPY® nasal spray. 2. REZENOPY® aims to address opioid overdoses effectively. 3. Commercial availability expected in early Q2 2026. 4. Naloxone market sales estimated at $154 million annually. 5. REZENOPY® provides high-strength naloxone for emergency treatment.

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FAQ

Why Bullish?

The launch of REZENOPY® taps into an established $154 million market, showing potential for strong revenues. Historical success of similar FDA-approved products suggests SCNX could benefit significantly.

How important is it?

The introduction of REZENOPY® represents a strategic move into a large market, enhancing SCNX's product portfolio. Its potential effectiveness in overdose situations aligns with urgent public health needs, indicating strong demand.

Why Short Term?

Commercial availability in Q2 2026 will drive immediate attention and potential revenue growth. Short-term market responses to new product launches often reflect in the stock shortly after.

Related Companies

SCIENTURE Holdings, Inc. Announces Upcoming Launch of REZENOPY® Naloxone Nasal Spray

Commack, NY – December 22, 2025 – SCIENCE HOLDINGS, INC. (NASDAQ: SCNX), a pharmaceutical company dedicated to delivering enhanced value through novel medication solutions, has today released an update regarding the commercial launch of its FDA-approved product, REZENOPY®. This high-strength naloxone hydrochloride nasal spray is poised to address critical needs within the opioid overdose emergency treatment market.

Commercialization Agreement for REZENOPY®

In March 2025, Scienture, LLC—an entirely owned subsidiary of Scienture Holdings, Inc.—entered into a definitive agreement with Summit Biosciences Inc., aligned with Kindeva’s expertise, granting exclusive U.S. commercialization rights for REZENOPY®. Approved by the FDA on April 19, 2024, REZENOPY® stands out due to its unique formulation and delivery system, rendering it the highest strength naloxone available at 10 mg.

According to the latest IQVIA data (MAT September 2025), the U.S. naloxone market has seen approximately $154 million in annual sales, encompassing about 9.3 million units sold. This positions REZENOPY® strategically to fulfill critical needs in a rapidly evolving market.

Highlights of REZENOPY® and Its Market Readiness

REZENOPY® represents a pivotal advancement in overdose response protocols due to its high strength,” stated Narasimhan Mani, President and co-CEO of Scienture. “It is specifically designed for patients who are at risk of requiring multiple doses of lower-strength naloxone for stabilization during emergencies.”

Shankar Hariharan, Executive Chairman and co-CEO, added, “Our manufacturing efforts are on track for completion in the first quarter of 2026, with plans to load REZENOPY® into the wholesale channel by this timeframe. This product aims to meet a critical and growing demand for improved opioid overdose interventions.”

  • Expected Product Availability: Initial release slated for Q1 2026.
  • Commercial Supply Start: Early Q2 2026.

About REZENOPY® and Safety Information

REZENOPY® (naloxone HCl) Nasal Spray 10 mg is indicated for the emergency treatment of known or suspected opioid overdoses in both adult and pediatric patients. It is essential to administer the spray immediately in environments where opioid exposure is possible.

Key safety information includes:

  • Administration: Use only intranasally; seek emergency medical assistance post-administration.
  • Contraindications: Not for individuals hypersensitive to naloxone or its components.
  • Warnings: Continuous monitoring is critical, especially in patients with a history of opioid dependency or cardiovascular issues.

About Scienture Holdings, Inc.

SCIENCE HOLDINGS, INC. (NASDAQ: SCNX) is committed to enhancing patient outcomes through innovative pharmaceutical products. Our team is dedicated to addressing unmet medical needs across various therapeutic markets.

For further details, visit www.scientureholdings.com or www.scienture.com.

Forward-Looking Statements

This article contains forward-looking statements pertaining to the future performance and financial outlook of SCNX. Actual results may differ due to various factors, including market conditions and product acceptance.

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