MSD Animal Health Receives Positive CVMP Opinion for MOMETAMAX® ULTRA Ear Drops, Suspension for Dogs
Innovative single-dose topical treatment proven to safely and effectively treat clinical signs associated with otitis externa in dogs
MADISON, N.J., USA, October 24, 2022– MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) issued a positive opinion for MOMETAMAX® ULTRA (gentamicin sulfate, posaconazole and mometasone furoate monohydrate, ear drops, suspension for dogs), an innovative, single-dose topical product for the treatment of otitis externa in dogs.
Canine otitis externa is inflammation of the external ear characterized by redness, swelling and pain. It affects one in seven dogs seen in general practice. It most commonly manifests as an acute condition or as an acute flare-up of a recurrent condition. With otitis externa, inflammation alters the ear canal environment, allowing the bacteria and fungi present in the ear canal to multiply. Clinical signs of otitis externa can affect one or both ears.
MOMETAMAX ULTRA is a single-dose treatment that contains gentamicin, a bactericidal, concentration-dependent antibiotic that kills susceptible Gram-positive bacteria like Staphylococcus pseudintermedius found commonly in canine ears; posaconazole, a broad spectrum antifungal active against susceptible yeast found in canine ears; and mometasone furoate, a widely prescribed corticosteroid with high topical potency and few systemic effects that reduces inflammation.
“Traditional canine otitis externa treatment requires multiple days of application at home. The related stress and inconvenience for both dogs and owners may result in poor compliance, sometimes leading to frustration and treatment failure,” said Linda Horspool BVMS, PhD, DipECVPT, MRCVS, director, Global Scientific Marketing Affairs, MSD Animal Health. “Today’s positive opinion for MOMETAMAX ULTRA is an important step toward providing dog owners and veterinarians with assurance and dogs with relief from this common condition by offering a unique combination of three active ingredients in a convenient single-dose that is administered by the veterinarian for the safe and effective treatment of otitis externa in dogs.”
MOMETAMAX ULTRA is indicated for the treatment of acute otitis externa or acute exacerbation of recurrent otitis externa caused by mixed bacterial and fungal infections with Staphylococcus pseudintermedius susceptible to gentamicin and Malassezia pachydermatis susceptible to posaconazole. MOMETAMAX ULTRA provides peak concentrations in the external ear soon after application. In a multi-center field study, 100% of dogs with a mixed culture of Staphylococcus pseudintermedius and Malassezia pachydermatis experienced clinical improvement by two weeks and treatment success by four weeks after the single-dose treatment. MOMETAMAX ULTRA was well-tolerated, with no adverse events related to treatment observed in clinical trials.
About MSD Animal Health
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of MSD. Through its commitment to The Science of Healthier Animals®, MSD Animal Health offers veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. MSD Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com and connect with us on LinkedIn and Twitter.
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