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Seresto® (backgrounder)


12. April 2012

Seresto is the latest in a long line of innovative ectoparasiticides from one of the world’s leading animal health companies, with unparalleled protection against fleas and ticks for up to 8 months from a single application.

It is the first new treatment in more than a decade to offer combined tick and flea protection for both cats and dogs, and as the first product to offer repellency against ticks for cats as well as dogs, Seresto reduces the risk of vector-borne disease transmission from these parasites for up to 8 months.

The unique polymer matrix of Seresto provides dose adjusted release of two proven active ingredients: imidacloprid, a very potent insecticide, and flumethrin, a highly effective acaricide.

Research into the efficacy of this combination has demonstrated that these two active ingredients work synergistically to dramatically increase their efficacy. Laboratory trials confirm that the combination of imidacloprid and flumethrin is 100 times more effective against fleas than imidacloprid alone (based on in vitro studies).

The Novel Science of Seresto
Thanks to its innovative polymer matrix composition, the migration of active ingredients from the Seresto collar matrix to the surface adjusts depending on the concentrations of active ingredients within the lipid layer on the pet´s skin. This ensures a steady, low-dose release profile, providing optimal protection for up to 8 months.

How Seresto differs from other treatment options
Recent research has revealed that, despite the efficacy of spot-ons against fleas and ticks, 77% of spot-on users are inadvertently exposing their pets to the risk of disease for more than three quarters of the year as they are treating their pet less than 3 times per year on average, rather than the 12 times required to provide effective year-round protection from parasites

Seresto is available as a collar and can be worn by both cats and dogs. Thanks to the patented way Seresto works, it ensures each animal continues to get just the right low-dose protection for up to 8 months. It presents a valuable treatment option for the majority of pet owners who find it difficult to maintain the correct dosing schedule, giving optimal protection for pets and offering pet owners peace of mind.

Seresto is also the first product from across the animal health industry that repels and kills ticks and kills fleas in cats and dogs, thus reducing the risk of vector-borne disease transmission.

Seresto is the only product available that offers the proven insecticide imidacloprid and acaricide flumethrin embedded in a special polymer matrix to ensure optimal efficacy against both ticks and fleas, maintained for up to 8 months. Seresto has been designed to stay securely in place for an eight month period while ensuring safety from strangulation.

Efficacy of Seresto
The unique polymer matrix of Seresto enables it to release controlled doses of two proven active ingredients: imidacloprid, a very potent insecticide, and flumethrin, a highly potent acaricide with extraordinary tick repellent properties.

Research into the efficacy of this combination has demonstrated that these two active ingredients work synergistically to dramatically increase their efficacy. Laboratory trials confirm that the combination of imidacloprid and flumethrin is 100 times more effective against fleas than imidacloprid alone (based on in vitro studies).

Flea efficacy in dogs

  • Studies have confirmed a general efficacy of more than 95% against fleas for the duration of 7-8 months.
  • The high efficacy against fleas started immediately after treatment, resulting in 100% flea kill already at the first 24 hour count after the collar application.
  • The “speed of kill” efficacy was evaluated in a separate study demonstrating an excellent 100% efficacy within 2 hours after flea infestation.
Tick efficacy in dogs
  • The repellent effect of a Seresto treatment on ticks was confirmed in laboratory studies with collared dogs. After monthly infestations with Ixodes ricinus (castor bean tick) and Rhipicephalus sanguineus (Brown Dog tick) a sustainable repellent (anti-feeding) efficacy of 100% and 98% respectively could be demonstrated for 8 months.
Flea efficacy in cats
  • During six laboratory studies, Seresto proved to possess a general efficacy of >95% against fleas for the duration of 8 months.
  • The high efficacy against fleas in cats started immediately after treatment, resulting in 99.8% flea kill already at the first 24-hour count after the collar had been applied. The “speed of kill” efficacy was also evaluated in one study, and resulted in an excellent 100% efficacy two hours after flea infestation.
Tick efficacy in cats
  • For Rhipicephalus turanicus, the European cat equivalent of the Brown Dog tick R. sanguineus, Seresto’s efficacy was above 90% for 8 months. The excellent performance of the collar could also be recorded against Amblyomma americanum with high persistent preventive efficacy above 97% for 8 months.
  • Repellent (anti-feeding) efficacy compared to untreated control cats was 100% during the whole study period.
Comparative studies
  • The performance of Seresto against fleas and ticks was also evaluated in a long-term (8-month) clinical laboratory study with dogs, in comparison to a licensed deltamethrin collar and in comparison to a spot-on treatment (fipronil/methoprene).
  • In this study, Seresto offered better tick protection than either treatment at all time points, including in month 8.
  • Seresto also provided similar protection against fleas at month 8 when compared to newly applied fipronil + methoprene spot-on, along with constantly and statistically significantly lower flea counts when compared to the deltamethrin group across the study period.
  • In the Seresto group immediate flea efficacy 48 hours after collar application was 99.9% and the persistent flea efficacies after reinfestation were constantly =96.8% for 8 months, compared to less than 83% efficacies in the deltamethrin-treated dogs for the 6 month treatment period.
Real world data
  • The efficacy and safety of Seresto were also tested under normal conditions of use with naturally infested dogs in a controlled, randomized, multicentre field study conducted in Germany, France, Portugal and Hungary.
  • The percentage flea control in the field study was =95% for the duration of 8 months and there was an over 90% reduction in dogs showing clinical signs of FAD at the end of the study compared to the beginning.
  • The preventive efficacy against all ticks lasted for 8 months with >90% efficacy.
Seresto’s safety profile
Due to its dose-adjusted release, the choice and concentration of the active ingredients and its unique depot formulation, Seresto is safe for pets, families and the environment.

Safety in dogs

For the safety evaluation of Seresto, adult dogs were treated with one, three or five collars at the same time. In the 5x group collars were additionally replaced every two weeks for the duration of two months respectively every two months for the duration of eight months, to test for any initial elevated release of active ingredient of new collars.

During the observation period no adverse clinical signs besides minor mechanical transient skin reactions as e.g. hair thinning or erythema were observed.

In a similar safety evaluation in puppies (7 weeks old) collars in the 3x and 5x group were replaced monthly during a 6 month study. This study also confirmed the safety of Seresto; except minor mechanically local hair thinning, no adverse reactions related to treatment were recorded.

In total more than 600 dogs have been treated with Seresto (including laboratory and field studies) and the observed changes can be summarized as following: occasionally slight pruritus and/or erythema may be observed in animals that are not used to wearing collars on the first few days after fitting.

Slight hair loss and mild skin reactions may occur at the application site, which usually recover within one to two weeks without the need for collar removal. In single cases, temporary collar removal may be recommended until the symptoms have disappeared.

Concomitant treatments either during the laboratory studies in form of spot-on treatments or sedations or during the field study in form of a large variety of drugs (e.g. anthelmintics, antimicrobials, corticosteroids, vaccines) given simultaneously with the collar treatment or during the time the collar was worn, did not cause any observable adverse reactions.

Safety in cats

Adult cats were treated with one, three or five collars at the same time. Again, the collars in the 5x group were replaced every two weeks for the duration of two months respectively every two months for the duration of eight months.

No adverse clinical signs besides minor mechanical transient skin reactions as e.g. hair thinning or erythema and mechanically induced stress by the multiple collars were observed.

A similar study design was applied in the safety evaluation in kittens (10 weeks old). The collars in the 3x and 5x groups were replaced three times during a six month study. This study also confirmed the safety of Seresto; except minor mechanically local hair thinning, no adverse reactions related to treatment were recorded.

Local and general clinical tolerance has also been assessed in all other laboratory kinetic and efficacy studies as well as in the field studies. In total, 530 cats have been treated with Seresto (including laboratory and field studies) and the observed changes can be summarized as following: occasionally slight pruritus and/or erythema may be observed in animals that are not used to wearing collars on the first few days after fitting.

Slight hair loss and mild skin reactions may occur at the application site, which usually recover within one to two weeks without the need for collar removal. In single cases, temporary collar removal may be recommended until the symptoms have disappeared. Initially, slight and transient reactions as depression, change of food intake, salivation, vomiting and diarrhoea might occur in rare cases. As in other topical applications, allergic contact dermatitis might occur in hypersensitive animals.

Concomitant treatments either during the laboratory studies in form of spot-on treatments or sedations or during the field study in form of a large variety of drugs (e.g. anthelmintics, antimicrobials, corticosteroids, vaccines) given simultaneously with the collar treatment, or during the time the collar was worn, did not cause any observable adverse reactions.

Human safety

In all safety scenarios, human exposure to active ingredients and excipients of the imidacloprid/flumethrin collar was confirmed to be very low resulting in high Margins of Safety (MoS). No specific risk mitigations are considered necessary except the standard warnings and hygiene measures which are foreseen for medicinal products and which are addressed in the user instruction: “Keep out of the reach and sight of children. Keep the collar in the outer packaging until use. As with any veterinary medicinal product, do not allow small children to play with the collar, or to put it into their mouths. Pets wearing the collar should not be allowed to sleep in the same bed as their owners, especially children. People with known sensitivity to the ingredients of the collar should avoid contact with the collar. Immediately dispose of any remnants or cut-offs of the collar. Wash hands with cold water after fitting the collar.”

Seresto’s indication
Dogs
  • For the treatment and prevention of flea (Ctenocephalides felis) infestation for 7 to 8 months. Efficacy against fleas starts immediately after application of the collar.
  • Protects the animal’s immediate surroundings against flea larvae development for 8 months.
  • Seresto can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
  • The product has persistent acaricidal (killing) efficacy against ticks (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus) and repellent (anti-feeding) efficacy against I.ricinus and R. sanguineus for 8 months. It is effective against larvae, nymphs and adult ticks.
  • Ticks already on the dog prior to treatment may not be killed within 48 hours after collar application and may remain attached and visible. Therefore, removal of ticks already on the dog at the time of application is recommended. The prevention of infestations with new ticks starts within two days after application of the collar.
  • For treatment of biting/chewing lice (Trichodectes canis) infestation.
Cats
  • For the treatment and prevention of flea (Ctenocephalides felis) infestation for 7 to 8 months. Efficacy against fleas starts immediately after application of the collar.
  • Protects the animal’s immediate surroundings against flea larvae development for 10 weeks.
  • Seresto can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
  • The product has persistent acaricidal (killing) efficacy against ticks (Ixodes ricinus, Rhipicephalus turanicus) and repellent (anti-feeding) efficacy against I. ricinus for 8 months. It is effective against larvae, nymphs and adult ticks.
Seresto within the Bayer Animal Health portfolio
Seresto is the first new treatment in more than a decade to offer combined tick and flea protection for both cats and dogs, with a single application of Seresto protecting against fleas and ticks for up to 8 months. As a result, it closes the existing gap for a product offering convenient, efficient, long-term protection.

Seresto is also the first product from across the animal health industry that repels and kills ticks and kills fleas in cats and dogs, thus reducing the risk of vector-borne disease transmission.

Overall, Seresto is an ideal product for all pet owners, as it reduces the need to remember monthly applications, improving compliance and offering unprecedented levels of protection from both ticks and fleas. For those customers who prefer to use a monthly spot-on treatment, Bayer continues to offer its full range of highly effective spot-on products such as Advantage, advantix and Advocate.

The science and passion of Bayer Animal Health
Seresto is the result of many years of multidisciplinary research effort across Bayer AG’s Crop Science, Material Science and Healthcare divisions, utilising Bayer´s unique experience and history  in insecticides research, polymer chemistry and technology and veterinary parasiticide development. 

Seresto demonstrates Bayer Animal Health’s commitment to improving the science of veterinary medicine, offering the first integrated long-term management option for the control of ticks and fleas that can be used with both cats and dogs.

Bayer Animal Health is committed to the responsible use of products; an appropriate Seresto treatment regimen established by a veterinarian will ensure adequate parasite control.

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