India Pharma Outlook Team | Wednesday, 15 January 2025
Hikma Pharmaceuticals PLC, the global pharmaceutical company, has formed an exclusive commercial alliance with Emergent BioSolutions for marketing KLOXXADO naloxone HCl nasal spray 8 mg in the U.S. and Canada. KLOXXADO received approval from the US Food and Drug Administration (FDA) in April 2021 for emergency treatment of confirmed or suspected opioid overdose, indicated by respiratory and/or central nervous system depression, in both adult and pediatric patients. Emergent markets NARCAN Nasal Spray 4 mg, the first FDA-approved naloxone product available over-the-counter for emergencies involving opioid overdose.
According to the six-year contract, Emergent will include KLOXXADO Nasal Spray in its naloxone product range and will manage all sales and marketing for the product in North America. Hikma will maintain the production of its 8 mg naloxone HCl nasal spray at its manufacturing plant in Columbus, Ohio, and will supply it exclusively to Emergent as its commercial partner.
“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,” said Hafrun Fridriksdottir, President of Hikma’s Generics business. “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. 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.”