Nexus Pharmaceuticals, Inc. announced that it has received US Food and Drug Administration (FDA) approval for EMERPHED (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes. The 10mL presentation is the first and only FDA-approved ready-to-administer 10mL pre-filled syringe available.
“We are pleased to announce the addition of our latest EMERPHED product to our suite of existing FDA-approved, ready-to-use ephedrine sulfate products,” said Chief Executive Officer and President, Usman Ahmed. “These patented products showcase Nexus’ ability to provide innovative therapies that address clinicians’ concerns about delivering efficient and safe medications. With EMERPHED, we look forward to transforming how patients are treated, while continuing to offer the quality they’ve come to expect.”
Nexus received FDA approval for EMERPHED (ephedrine sulfate) Injection in a ready-to-use vial in April 2020. A patent covering certain applications of EMERPHED Ready-to-Use Ephedrine Sulfate Injection was issued by the United States Patent and Trademark Office (USPTO) in August 2021. Nexus has since earned several additional patents on its EMERPHED line of vials and syringes and continues to pursue further patent protection related to EMERPHED.
In February 2021, the Medical College of Wisconsin published a clinical study showing the reduction of potential risk for error and ease of use of EMERPHED (ephedrine sulfate) Injection in a ready-to-use vial as compared to commercially used concentrated ephedrine. MCW published a press release with their findings in February 2021, and the clinical study was published in the Journal of Pharmaceutical Science and Technology in June 2021.
“In 2020, we were the first manufacturer to launch an FDA-approved ephedrine sulfate injection in a ready-to-use vial. Since that time, the market has changed and refined itself, so we are incredibly excited to introduce the next generation of ready-to-administer ephedrine sulfate products once again,” said Omair Ahmed, Chief Operating Officer.
Nexus Pharmaceuticals’ EMERPHED (ephedrine sulfate injection) pre-filled syringe is available immediately in cartons of ten single-dose syringes.