Eton Pharmaceuticals has secured the US Food and Drug Administration (FDA) approval for its Biorphen to treat hypotension resulting primarily from vasodilation in the setting of anesthesia.
The US pharmaceutical firm said that its Biorphen marks the first and only ready-to-use formulation of phenylephrine to secure the FDA approval.
Eton Pharmaceuticals chief executive officer Sean Brynjelsen said: “Today’s FDA approval of Biorphen addresses a critical medical need for an approved, ready-to-use standardized formulation of phenylephrine that can potentially reduce medication administration errors and improve patient safety.
“The approval of Biorphen represents an important step forward in Eton’s commitment to improving existing medicines to address unmet patient needs. We look forward to working with our manufacturing partner, Sintetica, to make Biorphen available to hospitals across the United States before the end of the year.”
Biorphen can be administered without diluting
Until the FDA approval of Biorphen, phenylephrine injection was available only as a highly concentrated formulation, which needed to be manually diluted for administration. The ready-to-use phenylephrine formulations are available only at 503B compounding pharmacies.
According to the company, compounded drugs are frequently associated with higher risks of a medication error, resulted by the lower regulatory standard, where compounded drugs are not considered for FDA premarket review for safety, effectiveness and manufacturing quality controls.
Eton said that the Biorphen is an alpha-1 adrenergic receptor agonist, which can be administered without diluting, to offer patient safety by reducing the risk of sterility breach and medication error.
In addition, Biorphen has been designed to have a three-year shelf life, and can be standardized and stocked in the operating room, emergency department and intensive care unit, and crash carts in hospital.
University of Illinois Chicago Hospital Anesthesiology Associate Professor Heather Nixon said: “Providers at the bedside need reliable, easy to use, safe drugs that have a consistent supply. Many hospitals outsource unapproved ready-to-use phenylephrine from 503B compounders, however often have to navigate supply disruptions through these suppliers.
“The availability of Biorphen will help address many of the underlying causes for risk and error associated with compounded phenylephrine while also reducing potential for waste associated with overdrawing medications. This will be an important new tool for anesthesiologists, pharmacists and other hospital providers in their efforts to enhance patient safety and prevent patient harm.”
