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news.Ovation Pharmaceuticals has launched the first new pharmaceutical product in 20 years to treat patent ductus arteriosus, a potentially life-threatening congenital heart defect in premature infants.
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NeoProfen (ibuprofen lysine) injection 10mg/mL is indicated – when usual medical management is ineffective – to close a clinically significant patent ductus arteriosus (PDA), a condition in which a blood vessel (ductus arteriosus) in the heart fails to close after birth.
In PDA, the opening between the pulmonary artery and the aorta does not close spontaneously after birth. Premature infants, particularly very-low-birth-weight neonates, are more likely to have problems related to PDA.
If the ductus arteriosus is large, does not close shortly after birth, and becomes symptomatic, the infant has a higher likelihood of pulmonary morbidity, necrotizing enterocolitis and the need for surgery.
“For 20 years, neonatologists had very few options for closing the ductus in very-low-birth-weight infants,” said Dr Jacob Aranda, of the Pediatric Pharmacology Research Unit Network at Children’s Hospital of Michigan in Detroit. “Few companies were willing to invest in new therapies for this population. NeoProfen offers a safe and effective treatment option, providing a significant benefit to physicians, patients and families.”