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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/437444/2013

EMEA/V/C/002635

EPAR summary for the public

Trifexis

Spinosad / milbemycin oxime

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 Trifexis?

Trifexis is a veterinary medicine that contains two active substances, spinosad and milbemycin oxime. Trifexis chewable tablets are available in five different strengths (270 mg/4.5 mg, 425 mg/7.1 mg,

665 mg/11.1 mg, 1040 mg/17.4 mg and 1620/27 mg) to cover a range of dog weights.

What is Trifexis used for?

Trifexis is used to treat and prevent flea infestations in dogs when there is also a need to prevent heartworm disease (roundworms that infect the heart and blood vessels and are transmitted by mosquitoes) and/or to treat gut infections by other types of worms (the nematodes hookworm, roundworm and whipworm).

Trifexis may also be used as part of a treatment strategy for the control of flea allergy dermatitis (an allergic reaction to flea bites).

Trifexis should be given with food or immediately after feeding at a dose of 45 - 70 mg spinosad and 0.75 - 1.18 mg milbemycin oxime per kg bodyweight. In areas where heartworm infection is known to occur, the first dose should be given one month before the expected appearance of mosquitoes and then at monthly intervals during the time of year when mosquitoes and fleas are present, until at least one month after the last exposure to mosquitoes. Trifexis should not be given for more than six consecutive months in any one year. In areas where heartworm infection does not occur, dogs may be given a single dose of Trifexis to prevent seasonal fleas when infections with gut nematodes have been

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diagnosed. Subsequent flea prevention should be with a different product containing a single active substance.

For the appropriate strength of tablet and number of tablets to be given, see the dosage table in the package leaflet.

How does Trifexis work?

One of the active substances in Trifexis, spinosad interferes with certain specific receptors (nicotinic acetylcholine receptors) in the fleas' nervous system, which results in their subsequent paralysis and death.

The second active substance, milbemycin oxime causes paralysis and death of nematodes and heartworm by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites' nervous system.

Trifexis can prevent fleas for up to four weeks after a single administration because it kills adult fleas and reduces egg production.

How has Trifexis been studied?

For prevention and treatment of flea infestations the company presented a field study in which 178 dogs were treated with Trifexis and 88 dogs were treated with another flea treatment product containing selamectin. The main measure of effectiveness was a reduction in flea count of 90% or more on day 14 and 30 after treatment.

For treatment of gut worm infections the company submitted a field study involving a total of 229 dogs. Trifexis-treated dogs were compared to dogs treated with milbemycin oxime alone. The measure of effectiveness was success rate based on the proportion of dogs with a reduction in the number of worm eggs in their faeces of 90% or more.

For prevention of heartworm disease the company submitted three laboratory studies involving dogs aged 4 to 9 months which were artificially infected with one of two strains of heartworm and then treated with Trifexis at different times after infection. Treatment with Trifexis was compared with a dummy treatment containing no active substance. The measure of effectiveness was reduction of heartworm counts from the heart and lungs of the dogs after 6 months.

What benefit has Trifexis shown during the studies?

The flea field study found a 90% reduction in flea count in 96.7% and 88.7% of Trifexis-treated dogs at day 14 and 30 respectively, compared with 85.9% and 73.2% in the selamectin-treated dogs.

The worm study showed Trifexis to have the same level of effectiveness against gut worms as milbemycin oxime.

The heartworm studies showed that a single treatment 30 days after inoculation gave 100% prevention for one strain, but three consecutive monthly treatments were needed for the other less susceptible heartworm strains.

What is the risk associated with Trifexis?

Trifexis must not be used in puppies less than 14 weeks of age.

Vomiting in the first 48 hours after treatment is common (seen in up to 1 in 10 animals). In most cases it is mild and short lived without requiring treatment. Other common side effects include lethargy (sluggishness), decreased appetite, diarrhoea, pruritus (itching), dermatitis (inflammation of the skin) and reddening of the skin and ear.

For a full list of all side effects reported with Trifexis, see the package leaflet.

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

Accidental ingestion may cause side effects.

If the medicine is accidentally ingested, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

Hands should be washed after handling the product.

Children must not come into contact with Trifexis.

Why has Trifexis been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Trifexis exceed the risks for the approved indications and recommended that Trifexis be given a marketing authorisation. The benefit/risk balance may be found in the scientific discussion module of this EPAR.

Other information about Trifexis:

The European Commission granted a marketing authorisation valid throughout the European Union, for Trifexis on 19/09/2013. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in July 2013.

Trifexis

EMA/437444/2013

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