Eton Pharmaceuticals Announces Commercial Availability of Biorphen® (phenylephrine HCI) Injection
~ Biorphen is the First and Only Ready-to-Use FDA-Approved Injectable Formulation of Phenylephrine ~
~ Biorphen is Now Available for Order Through Major Wholesalers ~
~ Biorphen is Eton Pharmaceuticals’ First Commercially Available Product ~
“Since Biorphen’s approval, we have seen strong interest from both physicians and hospital pharmacy directors and we are excited to begin supplying the product. The availability of Biorphen reduces the need for hospitals to rely on compounders to provide unapproved compounded phenylephrine,” said
“The teams at Eton and Sintetica have worked closely together to ensure that Biorphen is ready for launch and to assuredly supply
Eton estimates the total addressable market for Biorphen is more than 20 million units annually. In tandem with its manufacturing partner Sintetica, Eton expects to have the capacity to supply this market as necessary. Eton’s sales force currently includes a team of field representatives and inside sales representatives that will be initially targeting the institutions with the highest phenylephrine usage.
For ordering and product information visit www.Biorphen.com.
Biorphen® (phenylephrine HCI) Injection is the first and only
Indications and Usage
BIORPHEN injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Important Safety Information
Warnings and Precautions: BIORPHEN can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. Can also cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs. Extravasation during intravenous administration may cause necrosis or sloughing of tissue. Can cause severe bradycardia and decreased cardiac output, renal toxicity, augmented pressor effect in patients with autonomic dysfunction and pressor effect with concomitant oxytocic drugs.
Most common adverse reactions during treatment: nausea, vomiting, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact
- Agonistic Effects (increase in BIORPHEN blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids.
- Antagonistic Effects (decrease in BIORPHEN blood pressure effect) can occur with α-adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed α- and β-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents
Overdose of BIORPHEN (phenylephrine hydrochloride) can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.
About Eton Pharmaceuticals, Inc.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the
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Source: Eton Pharmaceuticals