Merck Animal Health (known as MSD Animal Health outside the USA and Canada) announced today that it has received positive opinion from the CVMP in the European Union for PANACUR® AquaSol (fenbendazole 200 mg/mL), a suspension for use in drinking water indicated for the treatment and control of gastro-intestinal nematodes. PANACUR AquaSol is exclusive for swine and is an improved pharmaceutical formulation of PANACUR that has been used successfully as a deworming agent for many years in a wide range of animal species.
The new formulation was made possible due to a refinement of the milling process, resulting in a smaller particle size and a more homogeneous particle size distribution. The practical advances are (1) more convenience due to a stable suspension in drinking water for up to 24 hours without the need for re-stirring and (2) a higher bioavailability of PANACUR AquaSol compared to PANACUR powder.
The approved indications of PANACUR AquaSol are the treatment and control of infections with Ascaris suum (adult, intestinal and migrating larval stages) and Oesophagostomum spp. (adult stages). It is well tolerated in pigs with no adverse effects being observed. The CVMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favorable benefit/risk balance for PANACUR AquaSol and therefore recommends the granting of the marketing authorization.
The active substance of PANACUR AquaSol is fenbendazole, an effective anthelminthic medicinal product from the benzimidazoles family, which acts by interfering with cell growth and cell division in helminths. This means that benzimidazoles are effective at killing both adult and larval stages of worm parasites as well as of killing of worm eggs (by interruption of embryonization). Fenbendazole is widely used as a deworming agent in a wide range of animal species.
Worm infections in swine do not commonly represent the severe clinical disease picture that is often seen in some other species, but that is not to say that helminths are not important. Whilst in specific circumstances, different worm parasites can cause severe clinical illness and even deaths in swine. Hence such parasite infections can be economically important to the swine business as they can interfere with piglet or sow vaccination, restrict growth, affect sow productivity and reduce animal feed efficiency.
November 7, 2011 - Merck Animal Health