Lipocine’s Preterm Birth Drug Wins Orphan Designation

Salt Lake City-based Lipocine’s investigational oral preterm labor prevention treatment is an orphan drug, the FDA says.

Orphan drug designation is granted to drugs that treat conditions affecting fewer than 200,000 people in the U.S. Lipocine says that at any time, there are 180,000 pregnant women in the U.S. who have experienced labor prior to 37 weeks.

The designation grants sponsors not only tax credits for clinical testing but also a waiver of prescription drug user fees. It also grants companies seven years of marketing exclusivity.

To obtain that exclusivity, Lipocine must prove to the FDA that LPCN 1107 (hydroxyprogesterone caproate) is superior to intramuscular injections of the compound, like KV Pharmaceutical’s Makena.

LPCN 1107’s superiority is mainly in convenience, the company says. An oral therapy would get rid of pain and site reactions stemming from weekly injections, as well as reduce visits to doctors’ offices or home visits by nurses that might interfere with daily activities.

Progesterone is a natural hormone that prevents contractions early in pregnancy. It declines sharply once labor begins. Phase I clinical trials in healthy women supported twice daily doses of 400 mg to 800 mg of LPCN1107.

Morgan Brown, executive vice president and chief financial officer of Lipocine, says pregnant women with a history of preterm birth would be dosed every week starting at 16 weeks and continuing until delivery. — Lena Freund