Lipocine Inc. announced receipt of additional guidance from the U.S. Food and Drug Administration (FDA) on the LPCN 1107 pivotal Phase 3 clinical study design.  LPCN 1107, a novel oral hydroxyprogesterone caproate (HPC) product candidate that has been granted orphan drug designation by the FDA, is in development for the proposed indication of reducing the risk of preterm birth (PTB) in women with singleton pregnancy who have a history of singleton spontaneous PTB. Prevention of PTB is a significant unmet need as 11.7% of all U.S. pregnancies result in PTB (delivery less than 37 weeks), a leading cause of neonatal mortality and morbidity. The recent guidance received is in addition to feedback provided at the End of Phase 2 meeting with the FDA which occurred in August 2016. During the End of Phase 2 meeting and subsequent guidance meetings, the FDA agreed to a randomized, open-label, two-arm clinical study to include a LPCN 1107 arm and a comparator IM arm with treatment up to 23 weeks.   The FDA also provided feedback on other critical Phase 3 study design considerations including: positive feedback on the proposed 800 mg BID Phase 3 dose and dosing regimen; confirmation of the use of a surrogate primary endpoint focusing on rate of delivery less than 37 weeks gestation rather on clinical infant outcomes; acknowledged that the use of a gestational age endpoint would likely lead to Subpart H approval as opposed to a full approval; and, recommended a non-inferiority study margin of 7% with interim analyses. Lipocine plans to submit the LPCN 1107 Phase 3 protocol to the FDA via a Special Protocol Assessment (SPA) in the first half of 2017.  LPCN 1107 is a novel oral product candidate in development for the prevention of recurrent preterm birth in women with singleton pregnancy.