Antares Pharma Provides Addl Update On QuickShot Testosterone Program

(RTTNews) - Antares Pharma, Inc. (ATRS) said that it has received a written update from the U.S. Food and Drug Administration or FDA related to its clinical development program for QuickShot Testosterone or QS T that the company believes is consistent with its previously disclosed interpretation of the advice letter received from FDA in January 2015.

As previously disclosed, the Company received an advice letter from FDA in January 2015 regarding various clinical, CMC (Chemistry, Manufacturing and Controls) and user study submissions made by the Company through November 2014, and the Company responded to that advice letter in March 2015.

The Company believes that with the update just received from FDA, there is an agreed upon path forward for the completion of an additional study to support the filing of a New Drug Application for QS T.

Based on the number of subjects in previous studies and in the current ongoing phase 3 study, the Company will need approximately 70 additional subjects exposed to QS T for six months, resulting in approximately 350 subjects exposed to QS T, with 200 subjects exposed for six months and 100 subjects exposed for a year.

The company noted that it is now finalizing the protocol for the study and expects to initiate the trial in the third quarter of 2015.