Scienture Holdings, Inc. (NASDAQ: SCNX) announced that its subsidiary, Scienture, LLC, will begin commercial distribution of REZENOPY® 10 mg naloxone HCl nasal spray. The product received FDA approval on April 19, 2024 and the company secured exclusive U.S. commercialization rights in March 2025. Manufacturing is slated to be complete by the first quarter of 2026, with wholesale channel loading in the same period and commercial availability expected in early Q2 2026.
REZENOPY® is the highest‑strength naloxone available in the United States, offering a 10 mg dose that can address overdoses involving potent or multiple opioids. The U.S. naloxone market is estimated at $154 million in annual sales and 9.3 million units sold each year, according to IQVIA data. Competitors include Kloxxado (8 mg), Rextovy (4 mg), Narcan (4 mg), ReVive (3 mg), and an OTC 4 mg nasal spray launched by Amneal in April 2024. REZENOPY®’s 10 mg strength positions it as a distinct option for high‑potency overdoses.
Manufacturing will be conducted by a contract manufacturer with experience in sterile nasal products, and the company has confirmed that production capacity will meet the projected demand. The product will be loaded into the wholesale channel during Q1 2026, and the first commercial shipments are planned for early Q2 2026, aligning with the company’s broader rollout strategy for specialty pharmaceuticals.
While the launch represents a significant revenue opportunity, Scienture’s financial profile remains challenging. In Q3 2025, the company reported revenue of $590,050, up from $64,861 in the same period a year earlier, but it continued to post net losses and a low current ratio, indicating limited liquidity. The company’s cash burn rate remains high, and it has yet to achieve profitability. Nevertheless, the successful commercialization of its flagship losartan liquid formulation, Arbli™, in Q3 2025 demonstrates the company’s ability to navigate the regulatory and distribution landscape.
Executive Chairman and co‑CEO Shankar Hariharan said the company is confident that the manufacturing timeline will be met and that REZENOPY® will fill an unmet need in the overdose response market. President and co‑CEO Narasimhan Mani highlighted the product’s design for patients requiring multiple doses, underscoring the company’s focus on patient‑centric solutions in critical therapeutic areas.
The introduction of REZENOPY® expands Scienture’s specialty portfolio and could generate substantial sales once the product reaches the market. However, the company’s ongoing financial constraints and the competitive naloxone landscape mean that successful commercialization will depend on effective pricing, distribution, and continued demand for high‑strength formulations. Investors will likely weigh the potential upside against the company’s liquidity challenges and the need for additional capital to support the launch.
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