LONDON, April 30, 2021 /PRNewswire/ -- 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.
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 in more than 50 countries 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
KLOXXADOTM (naloxone
hydrochloride) Nasal Spray Important Safety Information
CONTRAINDICATIONS
- Hypersensitivity to naloxone hydrochloride or to any of the
other ingredients in KLOXXADOTM
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, which you can find in the full
press release published on our website at
https://www.hikma.com/newsroom/#pageRS=1.
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: WW40054
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
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.