Elanco Launches Broad-Spectrum Canine Parasiticide

INDIANAPOLIS, Jan. 17, 2011 /PRNewswire/ -- Elanco Companion Animal Health has launched its second product in the new year with the launch of Trifexis™ (spinosad + milbemycin oxime), a broad-spectrum parasiticide that kills fleas and is indicated for the prevention and treatment of flea infestations, the prevention of heartworm disease and the treatment and control of adult hookworm, roundworm and whipworm infections in dogs and puppies 8 weeks and older, and 5 pounds of body weight or greater.

"Trifexis provides three types of parasite protection by combining two trusted active ingredients, spinosad and milbemycin oxime, into a convenient, monthly chewable tablet," said Steve Connell, DVM, director of technical, academic and consumer services for Companion Animal Health at Elanco. "It is a significant addition to the portfolio of parasiticide products available to veterinarians and pet owners. Trifexis is the fourth new product we have introduced in less than four years, delivering the innovation we promised when we launched Elanco Companion Animal Health."

Approved by the FDA, Trifexis starts killing fleas within 30 minutes and was 100% effective in four hours in a controlled laboratory study.(1) Trifexis also prevents heartworm disease caused by Dirofilaria immitis, and treats and controls adult hookworm (Ancylostoma caninum), roundworm (Toxocara canis & Toxascaris leonina) and whipworm (Trichuris vulpis) infections. The flavored chewable tablet can be offered like a treat, providing convenience for dog owners. It is available in five dosing sizes for dogs ranging from 5 to 120 lbs. Dogs greater than 120 lbs. may be treated by administering an appropriate combination of tablets.

The introduction of spinosad, one of the active ingredients in Trifexis, resulted in the receipt of a Presidential Green Chemistry Challenge Award(2) in 1999 from the U.S. Environmental Protection Agency. The award was presented to Dow AgroSciences LLC in the category of Designing Safer Chemicals for the introduction of spinosad as an insect control product for use on crops. This award demonstrates that spinosad as a technology for insect control has a favorable environmental profile. This award is not relevant to the safety and efficacy of Trifexis, nor does it confer any environmental benefit to Trifexis.

Trifexis is a prescription medication, available only through licensed veterinarians. To reinforce dispensing within the context of a valid veterinarian/client/patient relationship, all boxes and cartons of Trifexis contain a unique product tracking code.

Trifexis is the third product in Elanco's parasiticide portfolio. Comfortis® (spinosad), the first FDA-approved, chewable beef-flavored tablet that kills and prevents fleas for a full month, was launched in 2007. Comfortis quickly became a valuable tool in the fight against fleas, particularly in the flea-endemic Gulf Coast region of the U.S., where veterinarians have made Comfortis their No. 1 choice for dogs.(3) Assurity™, a topical flea treatment for cats, was registered with the EPA and launched earlier in January.

For more information about Trifexis, pet owners should ask their veterinarian or visit trifexis.com.

About Elanco

Elanco is a global innovation-driven company that develops and markets products to improve animal health and food animal production in more than 75 countries. Elanco employs more than 2,300 people worldwide, with offices in more than 40 countries, and is a division of Eli Lilly and Company, a leading global pharmaceutical corporation. Additional information about Elanco is available at www.elanco.com.

Important safety information about Trifexis

Serious adverse reactions have been reported following concomitant extra-label use of ivermectin with spinosad alone, one of the components of Trifexis chewable tablets. Treatment with fewer than three monthly doses after the last exposure to mosquitoes may not provide complete heartworm prevention. Prior to administration of Trifexis, dogs should be tested for existing heartworm infection. Use with caution in breeding females. The safe use of Trifexis in breeding males has not been evaluated. Use with caution in dogs with pre-existing epilepsy. Puppies less than 14 weeks of age may experience a higher rate of vomiting. If vomiting occurs within an hour of administration, redose with another full dose. The most common adverse reactions recorded during clinical trials were vomiting, pruritus, lethargy and diarrhea. For product label, including complete safety information, see attached.

Important safety information about Comfortis

The most common adverse reaction reported is vomiting. Other adverse reactions reported in decreasing order of frequency are: depression/lethargy, decreased appetite, incoordination, diarrhea, itching, trembling, excessive salivation and seizures. Following concomitant extra-label use of ivermectin with Comfortis, some dogs have experienced the following clinical signs: trembling/twitching, salivation/drooling, seizures, incoordination, excessive dilation of pupils, blindness and disorientation. Post-approval experience continues to support the safety of Comfortis when used concurrently with heartworm preventatives according to label directions. For product label, including complete safety information, see attached label.

About Assurity

Always read, understand and follow label and use directions.

(1) For full study details, see Comfortis FOI: NADA 141-277 at www.fda.gov.

(2) The Presidential Green Chemistry Challenge Award; www.epa.gov

(3) Ipsos-Forward/Elanco Market Research, August 2010

©2011 Elanco TFX00111 010411

SOURCE Elanco Companion Animal Health