Inspire Pharmaceuticals to increase production of azithromycin ophthalmic solution

Sep 10 2009

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that it has been communicating with the U.S. Food and Drug Administration (FDA) and is increasing its production of AzaSite^® (azithromycin ophthalmic solution) 1% in response to the manufacturing supply shortage of erythromycin ophthalmic ointment (0.5%). Erythromycin ophthalmic ointment is a macrolide antibiotic routinely used in neonates for prophylaxis of ophthalmia neonatorum, a form of bacterial conjunctivitis that may be contracted by newborns during delivery. If not treated, the infection can be serious and may lead to blindness. Erythromycin ophthalmic ointment was recently placed on the FDA Drug Shortages website list, which was developed to respond to drug shortages that may have a significant impact on public health.

The Centers for Disease Control and Prevention (CDC), the FDA and the American Academy of Ophthalmology (AAO) have asked healthcare professionals to reserve current supplies of erythromycin ophthalmic ointment for neonatal prophylaxis use and to use alternative drugs for the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin, as well as for treatment of post-surgical and post-traumatic events.

Furthermore, the CDC recommended AzaSite as an acceptable substitute for neonatal prophylaxis use where erythromycin ophthalmic ointment is not available. The recommendation was made on the basis of available data on pharmacology and gonococcal microbiologic sensitivity. AzaSite contains azithromycin, a macrolide antibiotic, and is formulated for topical ophthalmic use; however, AzaSite has not been approved by the FDA for the treatment of prophylaxis of ophthalmia neonatorum and no clinical trials have been conducted using AzaSite in this population.