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BRIEF-Lipocine receives FDA guidance on the phase 3 program for LPCN 1107
January 9, 2017 / 12:29 PM / 8 months ago

BRIEF-Lipocine receives FDA guidance on the phase 3 program for LPCN 1107

Jan 9 (Reuters) - Lipocine Inc

* Lipocine receives FDA guidance on the phase 3 program for LPCN 1107, an oral alternative for the prevention of preterm birth

* FDA agreed to randomized, open-label, two-arm clinical study to include a LPCN 1107 arm and comparator im arm with treatment up to 23 weeks

* Plans to submit LPCN 1107 phase 3 protocol to FDA via a special protocol assessment in first half of 2017

* FDA confirmed use of surrogate primary endpoint focusing rate of delivery less than 37 weeks gestation rather than clinical infant outcomes

* FDA acknowledged that use of gestational age endpoint would likely lead to subpart h approval as opposed to full approval

* FDA recommended a non-inferiority study margin of 7 pct with interim analyses Source text for Eikon: Further company coverage:

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