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Aratana bags Nocita label extension with feline approval

Aug 06, 2018 - Animal Pharm
By Sian Lazell

Aratana Therapeutics has received US FDA approval of a label extension for Nocita to include cats.

Nocita (bupivacaine liposome injectable suspension) was originally developed as a local post-operative analgesic for cranial cruciate ligament surgery in dogs. With the label extension, Nocita is now also approved for use in cats as a peripheral nerve block to provide regional post-operative analgesia following onychectomy.

Nocita is designed to provide up to 72 hours of post-operative pain relief. Results from a pivotal field study in 241 client-owned cats showed Nocita met efficacy success criteria of no required rescue analgesia and the animals demonstrated a statistically significant improvement in pain evaluation success rates.

Additionally, in a 22-day laboratory safety study with cats receiving Nocita, bupivacaine hydrochloride or saline as a femoral nerve block, Nocita was well-tolerated on days 0, 9 and 18 at doses that were one, two and three times the maximum labeled total dose of 10.6 mg/kg/cat.

Aratana first submitted the supplemental new animal drug application for an extension for the use of Nocita in cats in June.

The Leawood, Kansas-based pet therapeutics specialist recently published its financial results for the second quarter of 2018.

Although the firm's revenues were down 6% year-on-year, it witnessed good underlying growth – sales were up on a quarterly basis, net loss was down compared to the same quarter in 2017 and R&D expenses also decreased.

Aratana is still a relatively young commercial entity. The firm started to see its first significant revenues in Q3 2017, after several years of intensive R&D. 

Reprinted with permission of Animal Pharm News




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