Dechra acquires the rights to Zenalpha^® (medetomidine and vatinoxan hydrochlorides injection)

Thursday, April 28, 2022

Vetcare and Dechra announce the FDA approval of Zenalpha^®

The U.S. Food and Drug Administration (FDA) has approved Zenalpha^® (medetomidine and vatinoxan hydrochlorides injection) for use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures and minor surgical procedures in the dog. Zenalpha was developed by Vetcare Oy in Finland, Dechra is Vetcare’s exclusive licensing partner for the drug. Zenalpha received central marketing approval from the European Medicine Agency (EMA) in December 2021. Dechra will become the marketing authorization (MA) holder in the US, while Vetcare will remain the MA holder in the EU.
Zenalpha is an innovative, balanced combination of medetomidine, an alpha2-adrenoceptor agonist, and vatinoxan, a novel alpha2-adrenoceptor antagonist. Vatinoxan only exerts effect peripherally and thus maintains the central sedative and analgesic effects of medetomidine while attenuating the peripheral cardiovascular effects. Zenalpha is the first sedative to possess this unique combination of active pharmaceutical ingredients and effects.
Sales of Zenalpha in the USA, the EU and the UK are planned to commence in 2022 through Dechra’s sales and marketing teams in those territories. Vetcare will be responsible for sales and marketing in Finland, Latvia, Lithuania and Estonia.
Ian Page, Dechra’s Chief Executive Officer commented: “Zenalpha is a great addition to Dechra’s well-established presence in the anesthesia and analgesia (A&A) category and will strengthen our leadership role in that therapy area. We are pleased to have partnered with Vetcare’s team over the last few years as they have finalized the approvals of Zenalpha in key markets. We look forward to successfully marketing the product through our experienced commercial and technical teams. Zenalpha will provide veterinarians with a novel therapeutic that is safe and effective for sedation in dogs.”
Olli Kuussaari, Vetcare’s Chief Executive Officer added: “Zenalpha is a milestone product developed by Vetcare’s team to provide an innovative pharmaceutical product for the global market in line with our strategy. We are pleased to have this partnership with Dechra to offer Zenalpha for veterinarians in key markets with Dechra’s leading professional team. We are excited to be part of a new era of canine sedation for animal wellbeing”.

About Dechra:

Dechra is global specialist veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture and sales and marketing of high quality products exclusively for veterinarians worldwide. Dechra’s business is unique as the majority of its products are used to treat medical conditions for which there is no other effective solution or have a clinical or dosing advantage over competitor products.

About Zenalpha

Zenalpha is a new intramuscular injectable option for canine sedation and analgesia. It is a balanced combination of medetomidine and vatinoxan created specifically for use in veterinary medicine. Medetomidine is a racemic mixture containing the active enantiomer, dexmedetomidine, an alpha2-adrenoceptor agonist with sedative and analgesic properties. Vatinoxan, a novel molecule, is a peripherally selective alpha2-adrenoceptor antagonist which lacks activity in the central nervous system. By limiting its effects to peripheral organ systems, vatinoxan will prevent or attenuate the cardiovascular and other effects of dexmedetomidine outside the central nervous system when administered simultaneously with the alpha2-adrenoceptor agonist. The central effects of dexmedetomidine remain unaltered, although vatinoxan will reduce the duration of sedation and analgesia induced by dexmedetomidine, predominantly by increasing the clearance of the latter via improving the cardiovascular function. In the field efficacy trial, dogs treated with Zenalpha had a shorter time to onset of sedation, shorter duration of sedation (recovered quicker), and less cardiovascular and respiratory depression and adverse reactions compared to dogs in the control group receiving dexmedetomidine alone.

IMPORTANT SAFETY INFORMATION:

As with all drugs, side effects may occur. For use in dogs only. Not intended for use in cats. Not for use in humans. Avoid skin, eye or mucosal contact. In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician. DO NOT DRIVE as sedation, loss of consciousness, and changes in blood pressure may occur. People with cardiovascular disease and pregnant women should exercise special caution to avoid exposure. Uterine contractions and decreased fetal blood pressure may occur after accidental systemic exposure. Do not use Zenalpha in dogs with cardiac disease, respiratory disorders, shock, severe debilitation, that have hypoglycemia or are at risk of developing hypoglycemia, or are stressed due to extreme heat, cold or fatigue. Zenalpha should not be administered in the presence of pre-existing hypotension, hypoxia or bradycardia. Due to the pronounced cardiovascular effects of alpha2-adrenoceptor agonists, only clinically healthy dogs (American Society of Anesthesiologists [ASA] classes I and II) should be administered Zenalpha. Dogs should be monitored frequently during sedation for changes in heart rate, blood pressure, respiratory rate and body temperature. Tachycardia may occur in some dogs after recovery from sedation. The following adverse reactions have been reported: diarrhea, muscle tremors and colitis. Refer to the prescribing information for complete details or visit www.dechra-us.com.

About Vetcare Oy

Vetcare Oy was established in 1992 to provide animals and the veterinarians caring for them with products that best suits the animals. This same approach still guides the company’s innovation initiatives today. Vetcare sells, markets, exports and develops medicines and other products that promote the wellbeing of animals globally. Every year the company invests a significant part of its operating profits in the development of products that suit animals better, along with pharmaceuticals and supplements to promote the wellbeing of animals. The revenue of Vetcare Group is approximately 50 million euros.

For more information, please visit: www.vetcare.fi/english

Dechra and the Dechra “D” logo are registered trademarks of Dechra Pharmaceuticals PLC. Zenalpha is a registered trademark of Dechra Limited.

For questions or further information, please contact Mike Eldred or Doug Hubert:

Mike Eldred, President, North American Operations, Dechra Veterinary Products, Mike.Eldred@Dechra.com

Doug Hubert, Vice President, Sales and Marketing, Dechra Veterinary Products, Doug.Hubert@Dechra.com