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LPCN 1107: Oral Product Candidate for Prevention of Preterm Birth
LPCN 1107 is an oral product candidate of 17-alpha hydroxyprogesterone caproate under development for the indication of prevention of recurrent preterm birth. LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal, family or professional activities associated with weekly visits.
Market Overview of Preterm Birth
Preterm Birth (PTB) is defined as delivery of less than 37 weeks of gestation. PTB occurs in ~12% of all US births. PTB remains the leading cause of perinatal mortality and morbidity, accounting for as many as 75% of perinatal deaths.
The expense associated with PTB involves not only the immediate cost of the preterm baby being treated in the hospital ICU setting, but includes the long term treatment costs for disabilities for the life of the child. Current total PTB related economic impact on the US health system far exceeds $26 billion, an estimated cost in 2006.
Behrman RE et al. in: Behrman RE, Butler AS, eds. Preterm Birth: Causes, Consequences, and Prevention. Washington, DC: The National Academies Press; 2006:329-354.
There is a significant unmet need for a ‘patient friendly’ product for the prevention of PTB. The only FDA approved product for the prevention of PTB must be given by an intra-muscular injection each week for a total of 18-22 injections.
LPCN 1107: A Novel Oral Alternative
LPCN 1107 Product Attributes:
- Designed for oral administration twice daily of hydroxyprogesterone caproate (same active as in the only FDA approvd injectable product for the prevention of recurrent PTB).
- Eliminates site reaction and pain at the site of injection
- Eliminates regular doctor office visits or visits from the nurse (weekly visits for 16 – 20 weeks)
- Significant absorption upon oral dosing of LPCN 1107 in healthy non-pregnant women
- Good dose response demonstrated in healthy non-pregnant women
- LPCN 1107 was well tolerated in single dose study
- LPCN 1107 may be eligible for orphan drug designation