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Intravenous Ibuprofen: State of Registration 17

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17

The European Commission granted an orphan designation for ibuprofen in the indication of treat- ment of patent ductus arteriosus (PDA) in February 2001 (registered as n° EU/3/01/20 in the European Register of Orphan Medicinal Products). Registra- tion is planned under the trade name Pedea®.

At that time, the COMP (Committee of Orphan Medicinal Products) located at the EMEA in Lon- don estimated the prevalence of the condition as being 2.13 in 10,000 persons.

PDA is a rare disorder. As no appropriate for- mulation of ibuprofen was available, there was an unmet medical need. Therefore, Orphan Europe, specialized in orphan drugs, decided more than 6 years ago to develop an appropriate formulation of ibuprofen to treat premature infants safely and efficiently.

This would lead to the first intravenous for- mulation of ibuprofen.

Pharmaceutical development work linked to the route of administration was performed. Spe- cial requirements were needed such as dedicated facilities and sterile atmosphere. Even though the toxicological profile of ibuprofen was already known for more than 40 years, Orphan Europe put in place additional studies related to the tar- get population and the route of administration.

The following animal studies were conducted:

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A local tolerance study conducted in rabbits comparing ibuprofen to placebo, using the iv route.

▬

An acute toxicity study using the iv route in newborn rats comparing the effects of ibupro- fen, saline solution and placebo.

Therefore after compilation of all the data, an application for marketing authorization was sub- mitted to the European Agency (EMEA) in May 2003.

The European registration of Pedea® is cur- rently on-going using the so-called centralized procedure (driven by Ireland acting as rappor- teur and the UK acting as co-rapporteur).

The CPMP (scientific committee responsible for the evaluation of quality, safety and efficacy of medicinal products submitted for registration) located at the EMEA has now released a positive opinion towards the registration (on 22 April 2004).

The European marketing authorization, appli- cable in the 25 countries of the enlarged European Union, is expected during summer (August 2004).

The therapeutic indication will be: »Pedea® is indicated for the treatment of hemodynamically significant patent ductus arteriosus in preterm newborn infants of less than 34 weeks of gesta- tional age«.

Pedea® will be presented as a box of 4 ampou- les of 2ml containing 5mg/ml of ibuprofen.

Intravenous Ibuprofen:

State of Registration

Marie Christine Fortun

(2)

V

Part V Perspectives

Chapter 18 Summary and Perspectives – 94

Michael Obladen

Riferimenti

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