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news.The US Food and Drug Administration (FDA) has granted orphan drug designation for Lipocine's oral hydroxyprogesterone caproate (HPC) product candidate, LPCN 1107, as a potential treatment for the prevention of preterm birth (PTB).
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Orphan drug status will provide the company with certain financial benefits such as tax credits for clinical trials, and waiver of prescription drug user fee for the marketing application.
The Orphan Drug Designation program provides orphan status to drugs and biologics which target a rare diseases/disorders that affects fewer than 200,000 people in the US, or that affect more than 200,000 persons but are not considered profitable.
In the US, there are about 180,000 pregnancies annually in women with a prior history of at least one preterm birth.
The company has already reported positive Phase Ib top-line results with LPCN 1107 in pregnant women. The trial showed that LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth.
Lipocine chairman, president and CEO Dr Mahesh Patel said: "We are pleased to receive orphan designation for LPCN 1107, as PTB represents a significant unmet medical need and we believe that LPCN 1107 has the potential to be the first oral product of the only approved drug for this significant opportunity.
"We expect to announce our clinical development plan for the program in the near future."
The company said that potential benefits of its oral product candidate include the elimination of pain and site reactions associated with weekly injections, and elimination of weekly doctor visits.