U.S. launch date for BI’s Pexion is uncertain
Plant capacity constraints will delay the noise aversion drug’s introduction.
Boehringer Ingelheim has earned U.S. approval of the noise aversion drug Pexion, but sales won’t begin anytime soon.
Pexion (imepitoin tablets) will be launched “in the future” for dogs sensitive to loud noises, spokesman Mark Bixler said.
“The company does not envision introducing Pexion in the United States in 2019, mainly as a result of capacity constraints at the manufacturing site,” he said.
Pexion, a prescription medication, is administered twice daily starting two days before an expected noise event, such as fireworks or gunshots, and is given throughout the event, the U.S. Food and Drug Administration reported Dec. 4. The scored tablets will be available in 100 and 400 mg dosages and prescribed based on a dog’s weight, the FDA added.
Pexion is not a new product. The European Commission in 2013 approved Pexion (imepitoin) for reducing the frequency of seizures associated with canine idiopathic epilepsy.
Other noise aversion solutions for dogs are on the U.S. market or coming soon.
Zoetis Inc. in 2016 received FDA approval of Sileo (dexmedetomidine oromucosal gel). Nestlé Purina PetCare is planning the January 2019 release of Purina Pro Plan Veterinary Supplements Calming Care, a nutritional supplement containing a probiotic that supports calmness.