Paragon BioTeck, Inc., Announces FDA Acceptance and Priority Review Designation of New Drug Application
TIGARD, Ore. — Paragon BioTeck, Inc., a privately held biopharmaceutical company specializing in the development of ophthalmic pharmaceuticals and therapies, today announced that the New Drug Application (NDA) for Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% to dilate the pupil has been accepted for review and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). Paragon submitted the NDA in September 2012 under Section 505(b)(2) of the Food, Drug and Cosmetic Act.
Priority designation is given to therapies that offer potential major advances in treatment, including improved safety, or provide a treatment where no adequate therapy exists. Based upon the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of March 21, 2013 for FDA action on the NDA.
About Phenylephrine Hydrochloride Ophthalmic Solution
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly α-adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic by constricting ophthalmic blood vessels and the radial muscle of the iris.
Phenylephrine Hydrochloride Ophthalmic Solution Important Safety Information
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension or thyrotoxicosis, as well as in pediatric patients under the age of one due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients. It’s for topical ophthalmic use only, and not for injection.
Serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, some fatal, and significant elevations in blood pressure have been reported. Caution is advised in pediatric patients less than five years of age, and in patients with elevated blood pressure, cardiovascular disease or hyperthyroidism. Blood pressure should be monitored in patients with cardiovascular or endocrine disease. Rebound miosis has been reported one day after instillation.
Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision and photophobia. Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage.
About Paragon BioTeck, Inc.
Paragon BioTeck, Inc., is a privately held ophthalmic-focused biopharmaceutical and medical device company pursuing the development and commercialization of products addressing unmet medical needs in the fight to protect and preserve eyesight.