Hikma launches cisatracurium besylate, gets OK for Kloxxado in Canada
Hikma is offering cisatracurium besylate injection in 200mg/20ml and 20mg/10ml doses.
The product is indicated as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age; to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU; and to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.
Cisatracurium besylate injection has a market value of approximately $14 million in the 12 months ending January 2025, per IQVIA.
Hikma also shared that Kloxxado (naloxone HCl) Nasal Spray 8 mg, has been approved by Health Canada for the treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult patients.
[Read more: Hikma gets FDA nod for generic Victoza, launches 2 new generics]
Kloxxado delivers 8 mg of naloxone hydrochloride per spray in a ready to use nasal spray to reverse the effects of opioid overdose.
“The approval of Kloxxado Nasal Spray will provide Canadian patients, friends and family members—as well as the healthcare and first responder communities—with an important treatment option for victims suffering from opioid overdose,” said Hafrun Fridriksdottir, president of Hikma Generics. “According to distinguished medical and health organizations, widely prescribing and distributing naloxone plays a vital role in the fight against opioid overdose. With the growing threat of stronger, more deadly synthetic opioids like illicit fentanyl, intranasal naloxone is an essential tool in that fight.”
Kloxxado Nasal Spray will be marketed and sold in Canada by Emergent BioSolutions (Emergent) under the terms of a recent six-year commercial agreement with Hikma, whereby Emergent will be responsible for all North America product sales and marketing. Hikma will continue producing Kloxxado Nasal Spray in its Columbus, Ohio manufacturing facility and will provide it to Emergent as its exclusive commercial partner. Following the approval of Kloxxado Nasal Spray, Emergent will engage Canadian agencies, private payers and provincial formularies, and aims to make Kloxxado available via prescription as early as 2026.
[Read more: Hikma intros Kloxxado]
“Across Canada, 22 innocent lives were lost each day to an opioid overdose fatality in 2023, which is why meeting the needs of our patients, communities and customers is so critical,” said Paul Williams, senior vice president and products business head, Emergent. “Narcan Nasal Spray has been an important 4 mg naloxone option to reduce opioid poisonings in Canada for years, and we believe Kloxxado Nasal Spray 8 mg may be beneficial for those who choose to administer a higher dose of naloxone. We are encouraged by the Health Canada approval and believe broadening our opioid antagonist offerings is a much-needed effort to help save lives from tragic opioid poisonings.”