LONDON, Aug. 4, 2021 /PRNewswire/ -- Hikma
Pharmaceuticals PLC (Hikma), the multinational
pharmaceutical company, announces the launch of
KLOXXADO™ (naloxone HCl) nasal spray 8mg in the US.
KLOXXADO™ was approved by the US Food and Drug
Administration (FDA) in April 2021
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.
"Last year, fueled by the COVID-19 pandemic and the increasing
prevalence of illicitly manufactured synthetic opioids, the number
of Americans who died from a drug overdose rose by nearly 30% to
more than 93,000, with approximately 75% of those deaths involving
opioids,1" said Desiree
Crevecoeur-MacPhail, Ph.D., Assistant Professor of
Psychology, Chapman University and
former Director of Quality Assurance and Utilization Management for
the Los Angeles Centers for Alcohol and Drug Abuse. "There is an
urgent need for additional resources to combat this epidemic, and
KLOXXADO™ will provide an important new tool for those
on the front lines of this fight."
"Naloxone has long been recognized as an important, safe and
effective treatment in the fight against opioid
overdose,2 but with the increasing prevalence of
illicitly manufactured synthetic opioids, organizations including
the CDC,3 the American Medical Association4
and others have noted that a higher dose of naloxone may be
required to revive a patient due to their high potency," said
Daniel Buffington, PharmD, MBA,
FAPhA, a clinical pharmacology specialist, President and
Practice Director at Clinical Pharmacology Service and faculty
member at the University of South
Florida Colleges of Medicine and Pharmacy. "As a
ready-to-use nasal spray that contains twice as much naloxone per
spray than the current standard of care, KLOXXADO™
provides an important new treatment for those suffering from an
opioid overdose."
In a survey of community organizations to which
Narcan® (naloxone HCl) nasal spray 4mg had been
distributed, 34% of attempted reversals used two or more
doses.5 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
years.6
"We are committed to ensuring KLOXXADO™ is widely
accessible to all who can benefit from it, including patients,
friends, family members and the public health community," 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."
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 overdoses.7
KLOXXADO™ 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. KLOXXADO™ is not a substitute for emergency
medical care. KLOXXADO™ is intended for immediate
administration as emergency therapy in settings where opioids may
be present.
KLOXXADO™ is a trademark of Hikma
Pharmaceuticals USA Inc.
NARCAN® is a registered trademark of ADAPT Pharma
Operations Limited.
Enquiries
Hikma Pharmaceuticals
PLC
Susan
Ringdal
EVP, Strategic
Planning and Global Affairs
|
+44 (0)20 7399 2760/
+44 7776 477050
uk-investors@hikma.uk.com
|
|
|
Steve
Weiss
David
Belian
US Communications and
Public Affairs
|
+1 732 720 2830/ +1
732 788 8279
+1 732 720 2814/+1
848 254 4875
uscommunications@hikma.com
|
|
|
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC:
HKMPY) (rated BBB-/stable S&P and BBB-/stable Fitch)
Hikma helps put better health within reach every day for
millions of people around the world. For more than 40 years, we've
been creating high-quality medicines and making them accessible to
the people who need them. Headquartered in the UK, we are a global
company with a local presence across the
United States (US), the Middle
East and North Africa
(MENA) and Europe, and we use our
unique insight and expertise to transform cutting-edge science into
innovative solutions that transform people's lives. We're committed
to our customers, and the people they care for, and by thinking
creatively and acting practically, we provide them with a broad
range of branded and non-branded generic medicines. Together, our
8,600 colleagues are helping to shape a healthier world that
enriches all our communities. We are a leading licensing partner,
and through our venture capital arm, are helping bring innovative
health technologies to people around the world. For more
information, please visit: www.hikma.com
KLOXXADO™ (naloxone hydrochloride)
Nasal Spray Important Safety Information
CONTRAINDICATIONS
- Hypersensitivity to naloxone hydrochloride or to any of the
other ingredients in KLOXXADO™
WARNINGS AND PRECAUTIONS
- Risk of Recurrent Respiratory and Central Nervous System
Depression
Seek emergency assistance immediately after administration of
the first dose and keep the patient under continued surveillance.
The duration of action of most opioids may exceed that of KLOXXADO,
resulting in a return of respiratory and/or central nervous system
depression after an initial improvement in symptoms. Administer
additional doses as necessary if the patient is not adequately
responding or responds and then relapses back into respiratory
depression.
- Risk of Limited Efficacy With Partial Agonists or Mixed
Agonist/Antagonists
Reversal of respiratory depression by partial agonists or mixed
agonist/antagonists may be incomplete. Larger or repeat doses of
naloxone hydrochloride may be required.
- Precipitation of Severe Opioid Withdrawal
Use in patients who are opioid-dependent may precipitate opioid
withdrawal characterized by body aches, diarrhea, tachycardia,
fever, runny nose, sneezing, piloerection, sweating, yawning,
nausea or vomiting, nervousness, restlessness or irritability,
shivering or trembling, abdominal cramps, weakness and increased
blood pressure. In neonates, opioid withdrawal may be
life-threatening if not recognized and properly treated and may
include convulsion, excessive crying and hyperactive reflexes.
Monitor the patient for the development of the signs and symptoms
of opioid withdrawal. For more information about management of
opioid withdrawal, see the full Prescribing Information.
Abrupt reversal of opioid effects in persons who were physically
dependent on opioids has precipitated an acute withdrawal syndrome.
In some patients, there was aggressive behavior upon abrupt
reversal of an opioid overdose.
Abrupt postoperative reversal of opioid depression after using
naloxone hydrochloride may result in nausea, vomiting, sweating,
tremulousness, tachycardia, hypotension, hypertension, seizures,
ventricular tachycardia and fibrillation, pulmonary edema and
cardiac arrest. Death, coma and encephalopathy have been reported
as sequelae of these events. These events have primarily occurred
in patients who had pre-existing cardiovascular disorders or
received other drugs that may have similar adverse cardiovascular
effects. Monitor these patients closely in an appropriate
healthcare setting.
ADVERSE REACTIONS
In two pharmacokinetic studies, a total of 47 healthy adult
volunteers were exposed to a single dose of KLOXXADO, one spray in
one nostril.
- The following adverse reactions were reported in two subjects
each: abdominal pain, asthenia, dizziness, headache, nasal
discomfort, and presyncope.
- Signs of nasal inflammation and nasal congestion were
observed
- Serious adverse reactions reported: none
The following most frequently reported events (in decreasing
frequency) have been identified primarily during post-approval use
of naloxone hydrochloride: withdrawal syndrome, vomiting,
nonresponsiveness to stimuli, drug ineffective, agitation,
somnolence, and loss of consciousness.
USE IN SPECIFIC POPULATIONS
Naloxone may precipitate opioid withdrawal in the pregnant woman
and fetus. Careful monitoring is needed until the fetus and mother
are stabilized.
In situations where the primary concern is for infants at risk
for opioid overdose, consider the availability of alternate
naloxone-containing products.
For more information, please see the full Prescribing
Information and Patient Information.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
https://www.fda.gov/medwatch or call 1-800-FDA-1088.
Distributed by: Hikma Specialty USA Inc., Berkeley
Heights, NJ 07922
Document Identification Number: HK-1267-v1
1 https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
2 https://emergency.cdc.gov/han/2020/han00438.asp
3 https://emergency.cdc.gov/han/2020/han00438.asp
4 https://apnews.com/article/opioids-business-health-government-and-politics-8263d4b147b3c6b104346b4ca31c28a3
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
7
https://www.fda.gov/consumers/consumer-updates/having-naloxone-hand-can-save-life-during-opioid-overdose
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SOURCE Hikma Pharmaceuticals USA Inc.