Hikma gets FDA nod for Kloxxado

Hikma has received the Food and Drug Administration’s stamp of approval for Kloxxado (naloxone hydrochloride) nasal spray 8 mg, for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.

Kloxxado contains twice as much naloxone per spray as Narcan Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important new treatment option in addressing the opioid epidemic.

Drug overdose, including most commonly opioid overdose, has been described as the “leading cause of accidental death” in the United States today – a situation that has been exacerbated by the COVID-19 pandemic.

According to health organizations, widely prescribing and distributing naloxone may play a vital role in the fight against opioid overdose. With the increasing prevalence of illicitly manufactured synthetic opioids, a higher dose of naloxone may be required to revive a patient, the company said.

In a survey of community organizations to which Narcan Nasal Spray 4mg had been distributed, 34% of attempted reversals used two or more doses. Additionally, a separate study published in 2019 found that the percent of overdose-related EMS calls in the United States requiring multiple doses of naloxone during 2013-2016 had increased to 21%, representing a 43% increase over those four years.

“The approval of Kloxxado is an important step in providing patients, friends and family members – as well as the public health community – with an important new option for treating opioid overdose,” said Brian Hoffmann, president of Hikma Generics. “As an experienced provider of addiction therapy treatments and a leading producer of nasal sprays in the United States, we are pleased to leverage our capabilities to deliver an important new tool in the fight against opioid overdose.”

Hikma expects Kloxxado to be available in the second half of 2021.