Eton Pharmaceuticals Inc. (NASDAQ: ETON) shares jumped on Tuesday after the firm announced that the U.S. Food and Drug Administration (FDA) has approved Biorphen.
Biorphen is the first and only FDA-approved ready-to-use formulation of phenylephrine for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Prior to the FDA approval of Biorphen, phenylephrine injection was only approved and available as a highly concentrated formulation that required hospitals to manually dilute the concentrate prior to administration.
Compounded drugs do not have to undergo FDA premarket review for safety, effectiveness and certain controls over manufacturing quality. Due to this lower regulatory standard, compounded drugs are often associated with higher risks of medication error.
Sean Brynjelsen, CEO of Eton Pharma, commented:
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.
Shares of Eton traded up about 8% Tuesday to $6.31, in a 52-week range of $5.13 to $10.20. The consensus price target is $15.50.