NOCITA® (bupivacaine liposome injectable suspension)

Aratana Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) Label Expansion

News in Brief

  • U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) approved the supplemental New Animal Drug Application (NADA) to expand the NOCITA label to include its use in cats as a peripheral nerve block to provide regional post-operative analgesia following onychectomy
  • NOCITA is a long-acting, local anesthetic that provides up to 72 hours of post-operative pain relief by releasing bupivacaine over time from multi-vesicular liposomes
  • Results from the pivotal field study in 241 client-owned cats showed NOCITA met efficacy success criteria of no required rescue analgesia and cats receiving NOCITA demonstrated a statistically significant improvement in pain evaluation success rates. At 72 hours, NOCITA success rates were 68.4 percent compared to 35.3 percent for placebo
  • Separately, in a 22-day laboratory safety study with cats receiving NOCITA, bupivacaine HCl or saline as a femoral nerve block, NOCITA was well-tolerated on days 0, 9 and 18 at doses corresponding to 1, 2 and 3 times the maximum labeled total dose of 10.6 mg/kg/cat (representing 2, 4 and 6 times the maximum labeled dose of 5.3 mg/kg/forelimb)
  • NOCITA is also FDA-approved for use in dogs to provide local post-operative analgesia for cranial cruciate ligament surgery

“NOCITA continues to elevate the standard of pain control in veterinary medicine. NOCITA provides veterinarians and their care teams with peace of mind that feline and canine patients undergoing certain painful surgeries will receive up to 72 hours of continuous, non-opioid pain relief.”

Ernst Heinen, DVM

Chief Development Officer, Aratana Therapeutics

IMPORTANT SAFETY INFORMATION

NOCITA® (bupivacaine liposome injectable suspension) is for use as a peripheral nerve block in cats only. Do not use in cats younger than 5 months of age, that are pregnant, lactating, or intended for breeding. Do not administer by intravenous or intra‐arterial injection. Adverse reactions in cats may include elevated body temperature, infection or chewing/licking at the surgical site. Avoid concurrent use with bupivacaine HCl, lidocaine or other amide local anesthetics. Please see the full Prescribing Information for more detail.

NOCITA® (bupivacaine liposome injectable suspension) is for local infiltration injection in dogs only. Do not use in dogs younger than 5 months of age, dogs that are pregnant, lactating or intended for breeding. Do not administer by intravenous or intra‐arterial injection. Adverse reactions in dogs may include discharge from incision, incisional inflammation and vomiting. Avoid concurrent use with bupivacaine HCl, lidocaine or other amide local anesthetics. Please see the full Prescribing Information for more detail.

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