SCIENTURE Broadens Commercial Access for REZENOPY™, Highest-Dose FDA-Approved Naloxone Nasal Spray, Through GPO Agreements Reaching Over 5,000 U.S. Institutions
Expands institutional footprint with potential penetration of more than ~ 60% of the U.S. market, while expanding reach across EMS providers and rehabilitation centers
U.S. naloxone market totals $141M with 9.4 million prescription units annually, represents significant commercial opportunity for REZENOPY™
COMMACK, NY, March 11, 2026 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ:SCNX), 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 announced that it has formalized multiple commercial Group Purchasing Organization (GPO) agreements for REZENOPYTM (naloxone HCl) Nasal Spray 10 mg, providing access to more than 5000 healthcare institutions, including hospitals, clinics and nursing homes, representing potential penetration into roughly 60% of the U.S. institutional market while also establishing a broad footprint across first responders, EMS providers and rehabilitation centers.
"These GPO agreements represent a significant step forward in the commercial expansion of REZENOPY™," commented Narasimhan Mani, President and co-CEO of Scienture. "They meaningfully expand our institutional reach, providing access to more than 5000 healthcare facilities representing potential penetration into approximately 60% of the U.S. institutional market. With the U.S. naloxone market representing approximately $141 million in annual sales and 9.4 million prescription units, we believe REZENOPY™, the highest-dose FDA-approved naloxone nasal spray, is well positioned to drive broader adoption and capture market share as we continue executing our commercialization strategy."
Shankar Hariharan, Executive Chairman and co-CEO of Scienture, added, "Institutional procurement channels are a key driver of growth for emergency overdose treatments. Through these GPO partnerships, we are significantly expanding our presence across hospitals, EMS providers, and rehabilitation centers, creating a scalable pathway for the adoption of REZENOPY™. We expect broader availability through these institutional channels to drive adoption and strengthen our growth trajectory as we scale our commercial operations."
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.
REZENOPY™ is the highest dosage naloxone HCl nasal spray approved by the FDA. The product leverages the proven use of the active ingredient and form factor, with increased effectiveness against potent opioids. IQVIA data (MAT January 2026) indicates total annual sales of $141 million, and unit volume of 9.4 million (eaches) for naloxone in the US market.
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.
IMPORTANT SAFETY INFORMATION
REZENOPY™ (naloxone hydrochloride) Nasal Spray 10 mg 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 and is not a substitute for emergency medical care.
Important Safety Information
- Contraindications: REZENOPY™ nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
- Warnings and Precautions:
- Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.
- Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
- Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
- Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
- Adverse Reactions: The following adverse reactions were observed in a REZENOPY™ nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.
For complete product information, including Patient Information, please refer to the full Prescribing Information.
About Scienture Holdings, Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: "SCNX"), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com.
Cautionary Statements Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed to be "forward-looking statements" within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, such as REZENOPY™, the success those products may have in the marketplace, and our strategies related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.
Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
Contact:
SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Phone: (866) 468-6535
Email: [email protected]
