Specialty pharmaceutical firm Lipocine has received orphan drug designation from the US Food and Drug Administration (FDA) for its LPCN 1107 to prevent preterm birth (PTB).

The LPCN 1107 is the firm’s oral hydroxyprogesterone caproate (HPC) product that has been developed for the prevention of PTB.

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Lipocine 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."

"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."

The FDA granted orphan drug status based on a plausible hypothesis that LPCN 1107 may be clinically superior to the same drug that is already approved for the same orphan indication, said the company.

LPCN 1107 has to show that it is clinically superior to the already approved drug, in a bid to obtain orphan drug exclusivity upon approval.

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The oral product candidate has the potential to eliminate pain and site reactions associated with weekly injections, as well as no longer requiring patients to have weekly visits to doctors or from nurses.

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The company previously revealed the positive Phase Ib top-line results of LPCN 1107 in pregnant women.

The product candidate LPCN 1021 showed positive top-line efficacy results in Phase III testing, which is targeted for testosterone replacement therapy.

Lipocine’s other candidate LPCN 1111 is currently in Phase II testing, which is a next generation oral testosterone therapy product with once daily dosing.