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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/704200/2014

EMEA/V/C/003842

EPAR summary for the public

Nexgard Spectra

Afoxolaner / milbemycin oxime

This 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 Nexgard Spectra?

Nexgard Spectra is a veterinary medicine that contains the active substances afoxolaner and milbemycin oxime. It is available as chewable tablets in five different strengths for use in dogs of different weights.

What is Nexgard Spectra used for?

Nexgard Spectra is used to treat flea and tick infestations in dogs when prevention of heartworm disease (caused by a roundworm that infects the heart and blood vessels and is transmitted by mosquitoes) and/or treatment of gut worms (hookworms, roundworms and whipworm) is also required. After being given, its actions last for 5 weeks against fleas and one month against ticks. Treatment should be repeated at monthly intervals during the flea or tick seasons. For heartworm disease, treatment is given monthly during the mosquito season. The appropriate strength tablet(s) should be used according to the dog's weight.

How does Nexgard Spectra work?

The active substances in Nexgard Spectra work by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and

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death of the parasitic organism.

Afoxolaner acts as an 'ectoparasiticide'. This means that it kills parasites that live on the skin or in the fur of animals, such as fleas and ticks. In order to be exposed to afoxolaner, fleas and ticks must attach to the skin and commence feeding on the dog's blood. Afoxolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' environment.

Milbemycin oxime acts as an 'endoparasiticide'. This means that it kills parasites like nematodes that live inside the body of animals.

How has Nexgard Spectra been studied?

The effectiveness of Nexgard Spectra was investigated in both laboratory and field studies.

For ectoparasites a field study involved 324 dogs with flea and/or tick infestations that were given a single treatment with Nexgard Spectra or a spot-on medicine containing pyripole that controls fleas and ticks. The measure of effectiveness was reduction in the number of fleas and ticks at day 30 after treatment.

For gut worms a field study involved 408 dogs with natural infections that were given either a single treatment with Nexgard Spectra or a medicine containing milbemycin oxime and praziquantel. The measure of effectiveness was reduction in the number of eggs in their faeces.

For heartworm a field study involving 84 dogs in Japan and 320 dogs in the USA, that tested negative for heartworm infection before treatment, were given either Nexgard Spectra or tablets containing milbemycin oxime and spinosad in the USA or tablets containing moxidectin in Japan. The measure of effectiveness was the absence of heartworm up to six months after the last treatment.

What benefit has Nexgard Spectra shown during the studies?

The ectoparasite field study showed that Nexgard Spectra was effective in treating flea and tick infestations in dogs for up to 30 days after treatment. Nexgard Spectra reduced the number of fleas and ticks by at least 95% and was at least as effective as pyripole.

The field study for gut worms showed that Nexgard Spectra was effective in reducing gut worms and was at least as effective as the milbemycin oxime and praziquantel.

The heartworm field study showed that Nexgard Spectra prevented heartworm infection as all dogs tested negative six months after the last treatment.

What is the risk associated with Nexgard Spectra?

The most common side effect (affecting in between 1 to 10 animals in 1,000 animals) was vomiting, diarrhoea, lack of energy, decreased appetite, and itching, which generally were short-lived and resolved spontaneously.

Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.

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

Tablets should be kept in the blister packs until required and the blisters should be kept in the carton.

In the case of accidental ingestion, particularly in the case of children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.

People handling the medicine should wash their hands after handling the product.

Why has Nexgard Spectra been approved?

The CVMP concluded that the benefits of Nexgard Spectra exceed the risks for the approved indications and recommended that Nexgard Spectra be given a marketing authorisation. The benefit-risk balance may be found in the scientific discussion module of this EPAR.

Other information about Nexgard Spectra:

The European Commission granted a marketing authorisation valid throughout the European Union, for Nexgard Spectra on 15/01/2015. Information on the prescription status of this product may be found on the label/outer package.

This summary was last updated in November 2014.

Nexgard Spectra

EMA/704200/2014

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