Chiesi launches the first standardized formula for treating primary apnea in the preterm infants.

-the disease affects 80% of newborn children up to 1,000 grams and 50% that weighs less than 1,500 grams

Barcelona, 2011-October laboratories Chiesi traded from this month the first standardized formula for the treatment of primary apnea of the preterm infants, indicated as oral and intravenous use of caffeine citrate. Peyona, name with which the drug is marketed especially addresses the treatment of this disease that affects 80% of newborn children up to 1,000 grams and 50 per cent of children who weigh less than 1,500 grams.

The effectiveness of short term caffeine citrate has been demonstrated with a 50% reduction in episodes of apnea in preterm infants, the need for ventilatory support and a lower incidence of BPD versus placebo. In the long term the drug produces a neuroprotective effect, improves the survival of the newborn without delayed neurological development, with a lower percentage of cerebral palsy and a minor neurologic disability in survivors between 18 and 21 months.

Peyona has also been approved by the European Medicines Agency (EMA) as ‘ an orphan drug ’, i.e., as a treatment for a disease that affects fewer than 5 people for every 10,000 in the European Union. The drug occurs with a concentration of 20 mg/ml of citrate of caffeine in sterile solution for oral and intravenous perfusion in drinkable single dose 1 ml.

The premature primary apnea

Primary apnea of preterm infants is characterized by the prolonged interruption of respiration, typically greater than 20 seconds, which may be accompanied by other factors such as hypoxemia, desaturation, hipercabia and/or bradycardia. The origin of the apnea is a poor control of breathing due to the immaturity of the central nervous system of the newborn premature.

Its incidence is inversely proportional to the gestational age, and affects 80% of newborn children up to 1,000 grams and 50 per cent of children who weigh less than 1,500 grams.

With the launch of Peyona, Chiesi, leading company in the area of Neonatology, wants to demonstrate its commitment to the Neonatology to develop orphan his first drug for the treatment of this disease that affects to the preterm infants. In addition, Peyona complies with quality assurance and traceability of each phial processes, which is an advantage over the formulations used so far.

CHIESI