Kindred Biosciences Launches Mirataz™ (mirtazapine transdermal ointment)

July 12, 2018

Kindred Biosciences, Inc., a biopharmaceutical company focused on saving and improving the lives of pets, announces the commercial launch of Mirataz™ (mirtazapine transdermal ointment) for the management of weight loss in cats.

Veterinarians can now immediately order Mirataz through their preferred animal health distributor, and pre-orders are shipping. In May 2018, Mirataz was approved by the U.S. Food & Drug Administration (FDA) Center for Veterinary Medicine (CVM), making it the first and only FDA-approved transdermal medication for the management of weight loss in cats.

“Mirataz gives veterinarians and their clients a practical way to manage feline weight loss without the need for administration of oral medication. Since it is applied topically, it does not depend on the cat’s willingness to eat to be medicated,” says Valentine S. Williams, DVM, MS, Dipl. ACVS, Director of Veterinary Affairs at KindredBio. “Until the approval of Mirataz, veterinarians had to rely on extra-label medications to manage weight loss in cats, including human oral mirtazapine tablets that may have inconsistent results.”1

Each year, about nine million cats experience weight loss due to underlying conditions.2 Weight loss is often a result of an underlying disease. Yet, prolonged weight loss can complicate illness by resulting in serious outcomes including hepatic lipidosis3, immune system dysfunction4 and delayed wound healing.4

Mirataz has been shown to be safe* and effective for managing unintended weight loss in cats. In clinical studies, Mirataz resulted in significant weight gain (3.9% increase in body weight in the mirtazapine treated group compared to 0.4% in the placebo group; n=177) in cats in as little as 14 days following topical application of 2 mg per day.5 In clinical studies, Mirataz was well tolerated, both locally and systemically, and was used in cats with unintended weight loss associated with a variety of underlying diseases.**5

Mirataz is available as a transdermal formulation applied to the inner pinna of the cat’s ear.

“Having an FDA-approved, topically applied alternative provides a new option for owners who have issues giving oral medications to their cats,” Dr. Williams says. “Veterinarians and pet owners are partners in ensuring a successful outcome of treatment for the feline patient. If the take-home treatment plan includes medications that are hard to administer, or not accepted by the cat, then it can put a strain on both the pet owner and the cat during an already stressful time. At KindredBio, we believe cats deserve products specifically developed for them. We are proud to say our first commercially available veterinary product, Mirataz, meets that unmet clinical need.”

To order Mirataz, veterinarians can contact their preferred animal health distributor, call KindredBio customer service at 1-888-608-2542 or visit http://kindredbio.com.

*Mirataz™ was demonstrated to be safe at the labeled dose of 2 mg per cat for 14 days.5

**Vomiting, application site reactions and behavior abnormalities (vocalization and hyperactivity) were reported in clinical field studies with the use of Mirataz.

Mirataz is indicated for the management of weight loss in cats.

Important Safety Information

Mirataz® (mirtazapine transdermal ointment) is for topical use in cats only under veterinary supervision. Do not use in cats with a known hypersensitivity to mirtazapine or any of the excipients. Do not use in cats treated with monoamine oxidase inhibitors (MAOIs). Not for human use. Keep out of reach of children. Wear gloves when handling/applying, wash hands after and avoid contact between the treated cat and people or other animals for 2 hours following application. Use with caution in cats with hepatic and kidney disease. Cat’s food intake should be monitored upon discontinuation. Safety has not been evaluated in cats less than 2 kg, less than six months of age or in breeding, pregnant or lactating cats. The most common adverse reactions observed during clinical trials were application site reactions, behavioral abnormalities (vocalization and hyperactivity) and vomiting. For product label, including complete safety information, click here.

References

1. Benson KK, Zajic LB, Morgan PK, et al. Drug exposure and clinical effect of transdermal mirtazapine in healthy young cats: a pilot study. J Feline Med Surg. 2017;19(10):998-1006.

2. 2017 Mirataz Pricing Research, Kynetec, September 2017 (n=204 U.S. small animal veterinarians). Data on file Kindred Biosciences. American Pet Products Association (APPA), 2017-2018 National Pet Owners Survey (n=22,202 respondents).

3. Armstrong J. et al. Hepatic Lipidosis in Cats. Vet Clin North Am Small Anim Pract 39 (2009) 599–616.

4. Chan D. The inappetent hospitalised cat: clinical approach to maximizing nutritional support. J Feline Med Surg. 2009;11:925-933.

5. Mirataz (mirtazapine transdermal ointment) Topical Use in Cats Only. [Full Prescribing
Information], Kindred Biosciences, Inc. (Burlingame, CA). Original: 5/2018.