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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/564692/2008

EMEA/V/C/127

EPAR summary for the public

Onsior

robenacoxib

This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal's medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

What is Onsior?

Onsior contains robenacoxib which belongs to a class of medicines that reduce fever, pain and inflammation. It is available as tablets in five different strengths (6 mg for cats, and 5 mg, 10 mg,

20 mg and 40 mg for dogs) and as a solution for injection (20 mg/ml for dogs and cats).

What is Onsior used for?

In cats, Onsior tablets are used for the treatment of acute (short term) pain and inflammation associated with musculoskeletal disorders (problems with the muscles and bones) and for moderate pain and inflammation associated with orthopaedic (bone) surgery. The solution for injection is used for the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery, such as neutering.

In dogs, Onsior tablets are used for the treatment of pain and inflammation associated with chronic osteoarthritis (a long-term disease causing pain in the joints). The solution for injection is used for the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery.

The tablets are given once a day at the same time every day, at a dose of 1 mg per kilogram body weight with a range of 1-2 mg/kg in dogs or 1-2.4 mg/kg in cats. Treatment in cats is limited to six days for musculoskeletal disorders. Dogs should be treated for as long as is needed. Cats should be given a single oral treatment prior to orthopaedic surgery. After surgery in cats, once daily treatment may be continued for up to two further days.

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The solution for injection is given as an injection under the skin to cats or dogs around 30 minutes before the start of the operation at a dose of 2 mg/kg. After surgery in cats, once daily treatment may be continued at the same dosage and at the same time every day for up to 2 days. .

How does Onsior work?

The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs). It works by blocking an enzyme called cyclo-oxygenase 2 (COX-2). This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation. By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.

How has Onsior been studied?

Onsior has been studied in laboratory animals, as well as 'clinical studies' in cats and dogs that were treated in veterinary practices and clinics across Europe and in the USA. In the clinical studies, Onsior was compared with other veterinary medicines containing NSAIDs (ketoprofen, meloxicam or carprofen) or a placebo (dummy treatment). The studies involved cats and dogs of different age groups, genders and breeds.

The tablets were studied over five to six days in cats with acute musculoskeletal disorders and for up to one year in dogs with osteoarthritis. The animals received the tablets once or twice a day. The effectiveness was determined based on examinations by a veterinarian and assessments by the animal's owner. In another study cats received tablets before orthopaedic surgery (of moderate nature) and then once daily for up to two days after surgery. The effectiveness of the tablets was measured based on the need to provide extra analgesic treatment (pain relief) to cats following surgery.

The solution for injection was studied in cats and dogs undergoing surgery. Pain was assessed by the veterinarian for up to 24 hours in dogs and 52 hours in cats after treatment, based on the animal's behaviour and responses to touching the inflamed area or moving the affected joint. The effectiveness of the solution for injection was investigated in another study in cats undergoing orthopaedic surgery where animals were given Onsior solution for injection once before and once daily for up to 2 days after surgery. Effectiveness was determined based on the need to provide analgesic treatment (pain relief) to cats following surgery.

What benefit has Onsior shown during the studies?

Onsior tablets given once a day reduced pain and improved mobility in both cats and dogs. Onsior was as effective as the comparator NSAIDs. In cats Onsior tablets reduced moderate pain and inflammation associated with orthopaedic surgery for up to 2 days post operation when compared to animals that received placebo.

The solution for injection caused a gradual decrease in pain scores in cats and dogs after the operation. After the end of the operation, sufficient pain control was seen up to 24 hours in dogs and up to 52 hours (2 days) in cats. Onsior was as effective as the comparator NSAIDs and more effective than placebo.

What is the risk associated with Onsior?

The side effects of Onsior are similar to those seen with other NSAIDs. The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as

Onsior

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vomiting, soft faeces and diarrhoea. In dogs, an increase in liver enzymes after long-term treatment with the tablets is common (affecting 1 to 10 animals in 100). In very rare cases, lethargy may be observed.

The solution for injection can also cause pain on injection. For a full list of all side effects reported with Onsior, see the Package Leaflet.

Onsior tablets must not be used in dogs or cats with existing problems affecting the stomach and gut, such as stomach ulcers or bleeding, or in dogs with liver problems. It must not be used in animals that are pregnant, nursing puppies or kittens or being used for breeding, or that are hypersensitive (allergic) to robenacoxib or any of the other ingredients. Care should be taken when treating cats or dogs with known heart or kidney problems, animals that are dehydrated and cats with liver problems. Onsior must not be used with other NSAIDs or with glucocorticosteroids.

What are the precautions for the person who gives the medicine or comes into contact with the animal?

Hands should be washed after giving the medicine to a dog or cat.

If the tablets are accidentally swallowed by a person, in particular by small children, or self-injection occurs with the solution for injection, the advice of a doctor should be sought immediately.

For pregnant women, particularly those in the later stages of pregnancy, accidental ingestion or selfinjection of Onsior might be dangerous for the unborn child.

Why has Onsior been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Onsior exceed the risks for the treatment of dogs and cats in the approved indications and recommended that Onsior should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.

Other information about Onsior:

The European Commission granted a marketing authorisation valid throughout the European Union for Onsior on 16.12.2008. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in November 2012.

Onsior

EMA/564692/2008