London-based Hikma Pharmaceuticals have received the FDA approval to market a higher dose of naloxone hydrochloride spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and paediatric patients.
The spray contains 8 milligrams of naloxone which is double the highest dose currently available (Narcan nasal spray 4mg). If naloxone is administered quickly, it can counter the opioid overdose effects, typically within minutes. The availability of a higher dose offers an additional treatment option for high-potency overdoses, the agency stated.
Naloxone hydrochloride is an opioid antagonist that antagonises opioid effects by competing for the same receptor sites. Administration of naloxone hydrochloride reverses the effects of opioids, including respiratory depression, sedation and hypotension. Naloxone has a long history of safe use as the standard of care for reversing opioid overdoses.
Kloxxado is not a substitute for emergency medical care. It is intended for immediate administration as emergency therapy in settings where opioids may be present.
Hikma expects Kloxxado to be available in the second half of 2021.