Acacia Pharma markets FDA‑approved hospital‑grade injectables for peri‑operative care, including Barhemsys® (IV amisulpride), a selective dopamine D₂/D₃ antagonist for postoperative nausea and vomiting, and Byfavo® (IV remimazolam), an ultra‑short‑acting benzodiazepine for procedural sedation up to 30 minutes. The company is also advancing APD403, a dual‑route amisulpride formulation targeting acute and delayed chemotherapy‑induced nausea and vomiting. Its direct U.S.
Funding
Funding not disclosed
Founders
Product
Problem
Patients undergoing surgery, invasive procedures, or chemotherapy frequently experience postoperative nausea and vomiting (PONV) or require rapid, controllable procedural sedation, leading to delayed discharge, reduced patient satisfaction, and increased healthcare costs. Existing antiemetic and sedative options often have suboptimal efficacy, safety profiles, or limited duration of action for short procedures. Oncology patients also lack an approved therapy that effectively prevents both acute and delayed chemotherapy‑induced nausea and vomiting (CINV).
Solution
Acacia Pharma delivers a portfolio of differentiated hospital‑grade pharmaceuticals that address these gaps. Barhemsys® (amisulpride injection) is a selective dopamine D₂/D₃ antagonist approved in the U.S. for the prevention and treatment of PONV in adult surgical patients. Byfavo® (remimazolam injection) is an ultra‑short‑acting intravenous benzodiazepine sedative approved for induction and maintenance of procedural sedation lasting up to 30 minutes, offering rapid onset and predictable recovery. The company’s late‑stage candidate APD403 combines the same selective dopamine antagonism in both intravenous and oral formulations to prevent acute and delayed CINV, having demonstrated safety and efficacy in Phase 2 studies. All products are marketed directly in the United States through Acacia’s own commercial organization, ensuring alignment with hospital formularies and anesthesia/surgical workflows. The portfolio leverages targeted pharmacology to improve patient comfort, shorten recovery times, and support hospital quality metrics tied to postoperative outcomes. By focusing on high‑impact therapeutic niches, Acacia creates a clear pathway from regulatory approval to bedside adoption.
Target Audience
Primary customers are anesthesia and surgical teams in U.S. hospitals, procedural‑sedation providers, and oncologists managing chemotherapy patients, as well as hospital pharmacy and formulary committees responsible for medication selection.
Features
- Barhemsys®: IV amisulpride injection, selective D₂/D₃ antagonism, FDA‑approved for PONV, with detailed prescribing and safety information.
- Byfavo®: IV remimazolam, benzodiazepine class, rapid onset (<2 min), short context‑sensitive half‑life, approved for procedural sedation ≤30 min, includes boxed warning and safety data.
- APD403: Dual‑route (IV and oral) amisulpride formulation targeting both acute and delayed CINV; completed proof‑of‑concept and Phase 2 dose‑ranging studies showing tolerability and efficacy.
- Proprietary formulation and dosing regimens designed for hospital use, compatible with existing anesthesia and peri‑operative protocols.
- Direct U.S. commercial infrastructure enabling hospital‑level distribution, formulary placement, and physician education.
- Compliance with FDA labeling, HIPAA‑compatible data handling for prescribing information, and adherence to U.S. regulatory standards.
- In‑licensed rights for Byfavo® from Paion UK Limited, ensuring exclusive U.S. market access.