Important milestone in combatting the opioid overdose
epidemic
LONDON, Oct. 3, 2023
/PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the
multinational pharmaceutical company, announces that on the
two-year anniversary of its launch, it has now donated more than
375,000 doses of KLOXXADO® (naloxone HCl) nasal spray
8mg in the US – an important milestone in its ongoing work to help
combat the opioid overdose epidemic.
KLOXXADO® contains twice as much naloxone per spray
as Narcan® (naloxone HCl) 4mg nasal spray, in a
ready-to- use format to reverse the effects of opioid
overdose.1 Since launching KLOXXADO® in 2021,
Hikma has donated the lifesaving medicine to harm reduction groups,
community organizations and others across the US. With the help of
more than 40 donation partners, KLOXXADO® has been
distributed for free in places it can have the biggest impact,
including music festivals, downtowns and schools.
"Since its launch two years ago, KLOXXADO® has
quickly become an essential tool for those on the front lines
working to reverse opioid overdoses and save lives," said
Brian Hoffmann, President, Hikma
Generics. "We are working closely with our partners across the
country to ensure the more than 375,000 doses of
KLOXXADO® that have now been donated are reaching those
who need it most, including patients, health care providers, first
responders, harm reduction groups and others. As the opioid
overdose epidemic continues, we are committed to expanding access
to KLOXXADO®, and all forms of naloxone that Hikma
manufactures, to meet the urgent needs of US patients and
communities."
As the US FDA, the White House Office of National Drug Control
Policy and others have noted, naloxone is a critical tool for
individuals, families, first responders and communities to help
reduce opioid overdose deaths, and expanding access to all forms of
naloxone is one of the top ways to address the overdose crisis.
In addition to KLOXXADO®, Hikma manufactures multiple
injectable formulations of naloxone, and – through its Hikma
Community Health™ initiative – has partnered with non-profits and
harm reduction organizations across the US to help expand access to
its entire naloxone portfolio, including by:
- Donating 50,000 vials of injectable naloxone in 2021 to
members of the Opioid Safety and Naloxone Network Buyers Club
(now called Remedy Alliance/For The People) to help ease a shortage
of the medicine facing non-profit harm reduction programs in the
US.
- Furthering its partnership with Remedy Alliance through a
first-of-its-kind agreement for Hikma to provide a private label,
discounted naloxone injectable medicine specifically for the harm
reduction community. As covered in The Washington Post, this
partnership ensures supply and price are no longer barriers to this
opioid overdose antidote to hundreds of harm reduction groups
nationwide.
- Ensuring widespread access to KLOXXADO® by
providing a Co-Pay Assistance Program for eligible individuals,
further increasing access and decreasing out-of-pocket costs to
this life-saving medication.
- Partnering with State Government and Community Programs to
expand access to our naloxone portfolio and continuing to provide
generic medications for the treatment of substance use
disorder to patients and health care providers.
Enquiries
Hikma
Pharmaceuticals PLC
Investors:
Susan
Ringdal
EVP, Strategic Planning
and Global Affairs
|
+44 (0)20 7399 2760/
+44 7776 477050
uk-investors@hikma.uk.com
|
Media:
Steve Weiss
David Belian
US Communications and
Public Affairs
|
+1 732 788
8279
+1 848 254
4875
uscommunications@hikma.com
|
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated
BBB-/stable S&P and BBB-/positive 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 North America, 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 8,800
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®️ is a registered trademark of Hikma
Pharmaceuticals USA Inc.
NARCAN® is a registered trademark of Emergent Operations
Ireland Limited.
Hikma Community Health™ is a trademark of Hikma
Pharmaceuticals USA Inc.
Important Safety Information for KLOXXADO®
(naloxone HCl) Nasal Spray 8 mg
Contraindications
Hypersensitivity to naloxone
hydrochloride or to any of the other ingredients
Warnings and Precautions
- Use KLOXXADO® right away if you suspect an
opioid overdose emergency, even if you are not sure, because an
opioid overdose emergency can cause severe injury or death. Signs
and symptoms of an opioid overdose emergency may include:
- Unusual sleepiness; you are not able to awaken the person with
a loud voice or by rubbing firmly on the middle of their chest
(sternum).
- Breathing problems, including slow or shallow breathing in
someone difficult to awaken or who looks like they are not
breathing.
- The black circle in the center of the colored part of the eye
(pupil) is very small (sometimes called "pinpoint pupils") in
someone difficult to awaken.
- Family members, caregivers or other people who may have to use
KLOXXADO® in an opioid overdose emergency should know
where KLOXXADO® is stored and how to give
KLOXXADO® before an opioid overdose emergency
happens.
- Get emergency medical help right away after using the first
dose of KLOXXADO®. Rescue breathing or CPR
(cardiopulmonary resuscitation) may be needed while waiting for
emergency medical help.
- The signs and symptoms of an opioid overdose emergency can
return after KLOXXADO® is given. If this happens, give
another dose after 2 to 3 minutes, using a new KLOXXADO®
device, alternating nostrils, and watch the person closely until
emergency medical help arrives.
- Do not use KLOXXADO® if you are allergic to naloxone
hydrochloride or any of the ingredients in
KLOXXADO®.
- KLOXXADO® can cause sudden and severe opioid
withdrawal, the symptoms of which may include body aches, diarrhea,
increased heart rate, fever, runny nose, sneezing, goosebumps,
sweating, yawning, nausea or vomiting, nervousness, restlessness or
irritability, shivering or trembling, stomach cramps, weakness and
increased blood pressure.
- In infants under 4 weeks old who have been receiving
opioids regularly, sudden opioid withdrawal may be life-threatening
if not treated the right way. Signs and symptoms include: seizures,
crying more than usual, and increased reflexes.
- Tell your doctor about all of your medical conditions
before using KLOXXADO®, including if you have heart
problems, are pregnant or plan to become pregnant, are
breastfeeding or plan to breastfeed.
- Tell your doctor about all of the medicines you take,
including prescription and over-the-counter medicines, drugs,
vitamins and herbal supplements.
Side Effects
The following serious side effect is
discussed in the full Prescribing Information for
KLOXXADO®:
- Sudden and Severe Opioid Withdrawal
Symptoms of sudden and severe opioid withdrawal resulting from
the use of KLOXXADO® in someone regularly using opioids
include: body aches, diarrhea, increased heart rate, fever, runny
nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting,
nervousness, restlessness or irritability, shivering or trembling,
stomach cramps, weakness and increased blood pressure.
Infants may have seizures, cry more than normal and have
increased reflexes.
Some people may become aggressive after abrupt reversal of
opioid overdose.
In two clinical studies, a total of 47 healthy adult volunteers
were exposed to a single dose of KLOXXADO®, one spray in
one nostril. Side effects were reported in two subjects for each of
the following: abdominal pain, asthenia, dizziness, headache, nasal
discomfort, and presyncope.
These are not all of the possible side effects of
KLOXXADO®. Contact your doctor for medical advice about
side effects.
Pregnancy, Infancy and Breastfeeding, Children
Tell
your doctor if you are pregnant or plan to become pregnant. If you
are pregnant and opioid dependent, use of KLOXXADO® may
cause withdrawal symptoms in you and your unborn baby. A healthcare
provider should monitor you and your unborn baby right away after
you use KLOXXADO®.
There is no information regarding the presence of naloxone in
human milk, the effects of naloxone on the breastfed infant or on
milk production.
If the primary concern is an infant at risk of an overdose,
consider whether other naloxone-containing products may be more
appropriate.
KLOXXADO® nasal spray is safe and effective in
children for known or suspected opioid overdose.
Dosage and Administration
Do not attempt to prime or
test-fire the device. Each KLOXXADO® Nasal Spray
contains only 1 dose of medicine and cannot be reused. Read the
"instructions for use" at the end of the Prescribing Information
and Medication Guide for detailed information about the right way
to use KLOXXADO® Nasal Spray.
Storage and Handling
Store KLOXXADO® at
room temperature between 68°F to 77°F (20°C to 25°C). Do not expose
to temperatures below 41°F (5°C) or above 104°F (40°C). Do not
freeze KLOXXADO®. Keep KLOXXADO® in its box
until ready to use. Protect from light. Replace
KLOXXADO® before the expiration date on the box. Keep
KLOXXADO® and all medicines out of the reach of
children.
For more information, please see the full Prescribing
Information and Medication Guide, which you can find on our website
at www.kloxxado.com.
- To report an adverse event or product complaint, please contact
us at us.hikma@primevigilance.com or call 1-877-845-0689 or
1-800-962-8364.
- Adverse events may also be reported to the FDA directly at
1-800-FDA-1088 or www.fda.gov/medwatch.
Distributed by: Hikma Specialty USA Inc., Columbus,
OH 43228.
1 Per prescribing information of KLOXXADO®
and NARCAN®
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SOURCE Hikma Pharmaceuticals USA Inc.