Emergent and Hikma Enter Six-Year Partnership to Sell Naloxone Spray in US and Canada
Kloxxado was approved by FDA in 2021 for emergency treatment of opioid overdose, and Emergent also distributes the FDA-approved over-the-counter treatment Narcan.
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Hikma Pharmaceuticals, of London, announced in a press release on Jan. 14, 2025, an exclusive commercial partnership, for a period of six years, with Emergent BioSolutions for the sale of Kloxxado (naloxone) hydrochloride (HCl) nasal spray, at a dosage of 8 mg, in the United States and Canada (1). Kloxxado was approved by FDA in April 2021 for emergency treatment of known or suspected opioid overdose manifested by respiratory and/or central nervous system depression, in both adult and pediatric patients.
According to the press release, Hikma will continue to produce its 8 mg naloxone HCl nasal spray at its manufacturing facility in Columbus, Ohio, and then provide it exclusively to Emergent (1).
The incidence and prevalence of opioid use in seven countries has been studied as part of the DARWIN EU project, short for Data Analysis and Real World Interrogation Network, which began in 2022. In announcing its intention to expand capacity for real-world data studies in 2024, the European Medicines Agency said the completed opioid study, and an additional study on take-home naloxone that was also conducted, helped to determine duration of prescription opioid use, characterization of users, and prescribing and dispensing indications (2).
"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," Hafrun Fridriksdottir, president of Hikma's Generics business, said in the press release. "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."
Emergent also distributes Narcan nasal spray, in 4 mg dose, the first FDA-approved, over-the-counter naloxone product for emergency treatment of opioid overdose (1).
Hikma last made headlines in December 2024 when its liraglutide injection was approved by FDA, making it the first generic version of Novo Nordisk’s Victoza, a glucagon-like peptide-1 receptor agonist, in the US, indicated for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes (3).
As for Emergent, word came in June 2024 that Bora Pharmaceuticals, of Taiwan, had expanded its North American footprint by making a $30 million purchase of an 87,000-square-foot sterile manufacturing facility, in Baltimore, Md., that had been previously owned by Emergent (4).
References
1. Hikma Pharmaceuticals. Hikma Announces Exclusive Commercial Partnership with Emergent BioSolutions for Kloxxado (naloxone HCl) Nasal Spray 8 mg. Press Release. Jan. 14, 2025.
2. HMA and EMA. Big Data Steering Group (BDSG): 2023 Report. Jan. 18, 2024.
3. FDA. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. Press Release. Dec. 23, 2024.
4. Bora Pharmaceuticals. Bora Pharmaceuticals Expands North American Footprint with Agreement to Acquire First Sterile Manufacturing Facility. Press Release. June 20, 2024.
