NEW YORK, Oct. 9, 2025 – ACA Pharma is pleased to announce that it has signed an exclusive distribution agreement with Eagle Pharmaceuticals, Inc. for ACA Pharma to commercialize Ryanodex® (dantrolene sodium for injection) and Barhemsys® (amisulpride injection) across Hong Kong, Macau, Singapore, and Greater China.

Ryanodex and Barhemsys are innovative hospital products with established use in the U.S. Ryanodex is indicated for the treatment of malignant hyperthermia and for the prevention of malignant hyperthermia in patients at high risk. Barhemsys is indicated in adults for the prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class as well as the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

ACA Pharma has already completed fast-track registration in Macau (30–90 days) for Ryanodex, while Barhemsys registration is still in progress, and is proceeding in parallel with Hong Kong and Singapore filings. In addition, ACA Pharma’s Macau team has scheduled meetings with China’s Center for Drug Evaluation (CDE) to prepare for national registration, while also working with Hainan authorities to include Ryanodex and Barhemsys on the Urgently Needed Clinical Medicines List for accelerated hospital adoption.

Despite the presence of local generics in China, imported originator medicines continue to hold a strong position and competitive advantage within the hospital sector. Leveraging ACA Pharma’s established fast-track regulatory pathways and its broader global distribution alliances, both products are also being positioned for expansion into Latin America, Asia, Europe, and other unregistered regions — bringing life-saving hospital therapies to a significantly wider patient population.

This agreement allows ACA Pharma to quickly provide healthcare professionals and patients with access to critical hospital medicines,” said Mike Zhou, CEO of ACA Pharma. “With Ryanodex already expanding into the Middle East and India through local registration and wholesale partnerships, and Barhemsys progressing toward national registration in China, we see significant opportunities to address urgent unmet needs across multiple regions.

About ACA Pharma

Founded in 1997, ACA Pharma is a U.S.-based pharmaceutical distributor providing end-to-end commercialization for U.S. and European originators across Greater China and Southeast Asia. ACA specializes in fast-track regulatory pathways, market access, medical affairs, supply chain, and commercial execution. Leveraging its Macau Fast Track platform, ACA enables patient access in as little as 30–90 days, reaching leading hospitals in the Greater Bay Area and beyond. For pediatric and orphan drugs, ACA also coordinates direct entry into China’s top pediatric hospitals and children’s medical centers — covering over 95% of rare disease patients nationwide — through group procurement across 45 designated hospitals, without requiring national registration. Learn more at www.acapharma.net.

About Eagle Pharmaceuticals, Inc.

Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Additional information is available on Eagle’s website at www.eagleus.com.

About Ryanodex®

• Ryanodex® (dantrolene sodium for injection) is FDA-approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.

Important Safety Information

• RYANODEX® is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia (MH), including discontinuing use of MH-triggering anesthetic agents, managing the metabolic acidosis, instituting cooling when necessary, and administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis).
• RYANODEX® is associated with skeletal muscle weakness such as loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea, and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to prevent extravasation of RYANODEX® into the surrounding tissue due to the high pH of the reconstituted RYANODEX® suspension and potential for tissue necrosis.
• RYANODEX® full Prescribing Information can be found at www.RYANODEX.com

About Barhemsys®

• Barhemsys® (amisulpride injection) is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, FDA-approved in adults for:
  
  • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
  • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis

Important Safety Information

Contraindication

• Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation

• Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.
• Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol.
• Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions

• Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).
• Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.
• The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Use in Specific Populations

• Pregnancy: Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

• Lactation
  • Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.
  • Barhemsys may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after Barhemsys treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.
  • To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of Barhemsys.

• Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

• Geriatric Use: No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Drug Interactions

• Barhemsys causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of Barhemsys in patients taking droperidol.
• ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
• Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and Barhemsys. Avoid using levodopa with Barhemsys.
• To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Media Contact

ACA Pharma: team@acapharma.net