Antares Pharma, Inc. ATD™ Formulation Enters Phase III Study

EWING, N.J.--(BUSINESS WIRE)--Antares Pharma, Inc. (Amex:AIS) announced that its development partner BioSante Pharmaceuticals has initiated a Phase III safety and efficacy trial of Antares’ transdermal testosterone gel (currently called LibiGel®) for the treatment of FSD. The Phase III trial is scheduled to enroll approximately 360 surgically menopausal women in a double-blind, placebo-controlled six month trial under a protocol and investigational new drug (IND) application reviewed by and on file with the U.S. Food and Drug Administration (FDA). It is currently anticipated that the Phase III safety and efficacy trials, plus one year of safety data, are the essential requirements for submission and approval by the FDA of a new drug application (NDA).

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