Hikma announces US FDA approval of KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg

Hikma announces US FDA approval of KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg

Important new option for reversing opioid overdoses

London, April 30, 2021 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration (FDA) 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.

KLOXXADOTM 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 US today1 – a situation that has been exacerbated by the COVID-19 pandemic2. According to health organizations, widely prescribing and distributing naloxone may play a vital role in the fight against opioid overdose3. With the increasing prevalence of illicitly manufactured synthetic opioids, a higher dose of naloxone may be required to revive a patient4.

In a survey of community organizations to which Narcan® Nasal Spray 4mg had been distributed, 34% of attempted reversals used two or more doses5. Additionally, a separate study published in 2019 found that the percent of overdose-related EMS calls in the US requiring multiple doses of naloxone during 2013-2016 had increased to 21%, representing a 43% increase over those four years6.

“The approval of KLOXXADOTM 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, Hikma Generics. “As an experienced provider of addiction therapy treatments and a leading producer of nasal sprays in the US, we are pleased to leverage our capabilities to deliver an important new tool in the fight against opioid overdose.”

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

About Naloxone

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 overdoses7.

KLOXXADOTM is indicated 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. KLOXXADOTM is not a substitute for emergency medical care. KLOXXADOTM is intended for immediate administration as emergency therapy in settings where opioids may be present.

KLOXXADOTM is a trademark of Hikma Pharmaceuticals USA Inc.

NARCAN® is a registered trademark of ADAPT Pharma Operations Limited.

1 https://pubmed.ncbi.nlm.nih.gov/29262202/

2 https://www.wsj.com/articles/the-opioid-crisis-already-serious-has-intensified-during-coronavirus-pandemic-11599557401?mod=article_inline

3 https://emergency.cdc.gov/han/2020/han00438.asp

4 https://emergency.cdc.gov/han/2020/han00438.asp

5 2016 FDA Advisory Committee on the Most Appropriate Dose or Doses of Naloxone to Reverse the Effects of Life-threatening Opioid Overdose in the Community Settings, Page 149: https://www.fda.gov/media/100409/download

6 2019 Geiger et. al., Substance Abuse: https://www.tandfonline.com/doi/abs/10.1080/08897077.2019.1640832