Hikma And Emergent Partner On KLOXXADO® Naloxone Spray Commercialisation In U.S. And Canada

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical group, has announced that it has secured an exclusive commercial deal with Emergent BioSolutions (Emergent) to distribute KLOXXADO® naloxone HCl nasal spray 8 mg in the USA and Canada. KLOXXADO® has been approved by the FDA in April 2021 to be used as an emergency treatment of known or suspected opioid overdose with signs and symptoms of respiratory and/or CNS depression in adult and paediatric patients. NARCAN® Nasal Spray 4 mg is an over-the-counter naloxone product for immediate use in treating opioid overdose and is distributed by Emergent.

Hafrun Fridriksdottir, President of Hikma’s Generics business, said in a statement, “We are thrilled to be partnering with Emergent, who have deep experience in getting lifesaving naloxone nasal spray into the hands of those who can use it to help save lives. This partnership combines Hikma’s excellent nasal spray manufacturing capabilities with Emergent’s well-established naloxone HCl nasal spray commercial expertise and strong stakeholder engagement. 

He further added, “Hikma remains committed to ensuring that all forms of naloxone we produce—KLOXXADO® Nasal Spray, as well as the injectable vials and prefilled syringes that we will continue to manufacture and market—are widely accessible to all who can benefit from them, including patients, friends, family members, and the public health community.”

The terms of the six-year partnership agreement mean that KLOXXADO® Nasal Spray will become a member of the Emergent calcium naloxone product range, and the company will be managing the sales and marketing in North America. Hikma will continue manufacturing its 8 mg naloxone HCl nasal spray in Columbus, Ohio, but it will sell it to Emergent as its sole distributor.