Emerphed is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent indicated for clinically important hypotension occurring in the setting of anaesthesia, and was initially approved for use in a ready-to-use vial
Emerphed single-dose pre-filled syringe. (Credit: Business Wire/ Nexus Pharmaceuticals, Inc.)
Nexus Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Emerphed (ephedrine sulphate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes.
Emerphed is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent indicated for clinically important hypotension occurring in the setting of anaesthesia.
The US-based healthcare company initially received FDA approval for Emerphed Injection in a ready-to-use vial, in April 2020.
The 10mL formulation is the first and only FDA-approved ready-to-administer pre-filled syringe available in this volume, said the company.
Nexus Pharmaceuticals president and chief executive officer Usman Ahmed said: “We are pleased to announce the addition of our latest EMERPHED product to our suite of existing FDA-approved, ready-to-use ephedrine sulphate products.
“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.”
In August 2021, Nexus secured a patent covering certain applications of Emerphed ready-to-use Ephedrine Sulphate Injection by the US Patent and Trademark Office (USPTO).
The company 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 a clinical study published by the Medical College of Wisconsin (MCW), Emerphed Injection in a ready-to-use vial reduced the potential risk for error and ease of use, compared to commercially used concentrated ephedrine.
Nexus Pharmaceuticals chief operating officer Omair Ahmed said: “In 2020, we were the first manufacturer to launch an FDA-approved ephedrine sulphate 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 sulphate products once again.”
In April last year, Nexus rolled out Erythromycin Lactobionate for Injection, an AP-rated generic to Erythrocin, in 500mg/vial in single-dose vials.