Metacam® receives EU approval for the relief of pain in castrated piglets

Ingelheim, Germany, 27 January 2010 - Boehringer Ingelheim’s Metacam® (active ingredient: Meloxicam) 5mg/ml solution for injection obtained EU wide marketing authorization for its use as an analgesic to relieve post operative pain associated with castration in piglets.

Following the positive opinion of the CVMP, the European Medicines Agency’s (EMEA) scientific committee, the EU commission announced their decision to authorize this new indication for Metacam.

The marketing authorization was expressed based on a specific study performed at the French Research Institute CTPA (Centre technique des productions animales et agro-alimentaires). The study confirmed a large body of evidence for the efficacy of Metacam generated earlier by the Faculty of Veterinary Medicine at the Ludwig-Maximilians-University in Munich, Germany. It demonstrated that Metacam administered at 0.4 mg/kg bodyweight prior to the castration of less than seven day old piglets had a significant impact on blood cortisol levels, a biochemical marker for the neuro endocrine reaction of the body to stress and pain. The study also demonstrated quicker alleviation of clinical symptoms and faster return to normal behaviour in piglets which received Metacam in comparison to animals which were not given analgesia.

“This decision helps veterinarians and farmers to move out of a highly uncomfortable situation of wanting to apply pain relief, but not having a legal and authorized option for effective post operative pain management“, says Dr. Joachim Hasenmaier, Head of Corporate Division Animal Health at Boehringer Ingelheim. “In many EU markets, changing attitudes meanwhile require or recommend the use of analgesia to help piglets to better cope with pain and to more quickly recover from the castration procedure. While the rationale was quickly adapted and accepted by veterinarians and farmers alike, no labelled product options were available for use which left them with the uneasy alternative of either not applying analgesia or of entering into unauthorized, off-label use of potential product options. This situation has ended now with the approval of Metacam.”

Metacam is a non-steroidal anti-inflammatory drug of the oxicam class. Metacam was first launched for pigs in 2003, and is now licensed in over 40 countries around the world.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

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