Re: [MaineOverdosePrevention] Digest for maineoverdoseprevention@googlegroups.com - 1 update in 1 topic

[Corey Davis]

"Opioid antagonist" means a drug that binds to opioid receptors and blocks or inhibits the effects of opioids acting on those receptors, including, but not limited to, naloxone hydrochloride."

http://www.mainelegislature.org/legis/bills/bills_126th/billtexts/HP120901.asp

On Thu, Apr 3, 2014 at 5:28 PM, <maineoverdo...@googlegroups.com> wrote:

  Today's topic summary

Group: http://groups.google.com/group/maineoverdoseprevention/topics

• FW: [NOPE_WG] naloxone auto injector #unsecure# [1 Update]

 FW: [NOPE_WG] naloxone auto injector #unsecure#

"Harper, Jayne" <Jayne....@MaineGeneral.org> Apr 03 01:35PM -0400  

This is an important point - does anyone know off the top of their head
if LD1686 specifically states IN naloxone or opioid antagonist, such as
naloxone?
 

 
Jayne
 

 
From: NOP...@googlegroups.com [mailto:NOP...@googlegroups.com] On
Behalf Of Alice Bell
Sent: Thursday, April 03, 2014 11:01 AM
To: NOP...@googlegroups.com
Subject: [NOPE_WG] naloxone auto injector
 

 
For those in states that are considering only allowing intranasal
naloxone, this announcement today would seem to bolster the argument
that it may be imprudent to institute policies that exclude new types of
technology that come on the market, specifically formulated for lay
administration?
 

 

 

 
http://www.digitaljournal.com/pr/1830949
 

 
Press Release
 
U.S. Food and Drug Administration Approves Kaleo's EVZIO(tm) for the
Emergency Treatment of Opioid Overdose
 
First and only naloxone product specifically intended for emergency
administration by family members or caregivers in settings where opioids
may be present
 
PR Newswire
 
RICHMOND, Va., April 3, 2014
 
RICHMOND, Va., April 3, 2014 /PRNewswire/ -- Kaleo (formerly
Intelliject) today announced that the U.S. Food and Drug Administration
(FDA) has approved EVZIO(tm) (naloxone hydrochloride injection) for the
emergency treatment of known or suspected opioid overdose, as manifested
by respiratory and/or central nervous system depression. EVZIO is the
first and only naloxone auto-injector intended to be available for
immediate administration by family members or caregivers for suspected
opioid overdose in settings where opioids may be present.1
 
Opioids are part of a class of pain medications that work by binding to
receptors in the brain that affect the body's perception of pain, and
can cause fatal overdose when the amount of drug in the body is too
high.2 Opioids are used to treat pain associated with a variety of acute
and chronic medical conditions. According to the Institute of Medicine,
chronic pain affects about 100 million American adults - more than the
total affected by heart disease, cancer and diabetes combined.3 More
than 16,000 Americans die each year from prescription opioid overdose,
and accidental drug poisoning has surpassed automobile collisions as the
leading cause of accidental death in the U.S., driven largely by
prescription opioids.4,5
 
Naloxone, the active ingredient in EVZIO, has been used for more than 40
years for reversal of respiratory depression due to opioid overdose, but
has been primarily used by emergency medical services, other medical
professionals and in limited naloxone distribution programs.6 EVZIO will
be available to patients and their family members or caregivers via a
healthcare professional's prescription. EVZIO should be administered as
quickly as possible when an opioid overdose is suspected because
prolonged respiratory depression may result in damage to the central
nervous system or death. Because people experiencing an opioid overdose
generally lose consciousness, in most cases, family members or
caregivers will likely be the ones who administer EVZIO. EVZIO uses
voice and visual cues to assist in guiding a user through the injection
process.1
 
"Kaleo was founded on the idea that patients are true experts on how
their conditions impact their lives, and EVZIO was developed with
patient and caregiver input throughout to make sure it would be easy to
use in stressful opioid emergencies with limited training," said Eric
Edwards, MD, PhD, Chief Medical Officer of kaleo. "Immediate
availability of EVZIO for family members and caregivers to administer
during a suspected opioid overdose has the potential to save many
lives."
 
"All patients taking an opioid pain medication accept some risk of
potential overdose. No medication is side effect free, and potent pain
relieving opioids have a narrow window of effectiveness, with some very
serious possible side effects including potentially life-threatening
respiratory depression," said Allen Burton, MD7, anesthesiologist and
pain specialist at Houston Pain Centers and former chairman of the
department of pain medicine at the University of Texas MD Anderson
Cancer Center. "Until now, most people had to rely on emergency medical
care to get access to an opioid reversal agent. Having naloxone
available for use by caregivers as soon as signs of overdose are
observed means an earlier intervention and better chance of survival."
 
The new drug application (NDA) for EVZIO was granted Fast Track status
and received a priority review by the FDA, which are regulatory pathways
to accelerate the review and approval of products that fill an unmet
medical need. EVZIO is expected to be available this summer through all
major pharmacies and via mail order with a healthcare professional's
prescription. An assistance program will be available to help patients
gain access to EVZIO.
 
"The FDA approval of EVZIO furthers our mission to make lifesaving
products that put patients first," said Spencer Williamson, CEO of
kaleo. "We are thankful to the patients and caregivers whose input
guided the development process and resulted in an intuitive and
important product we're proud to bring to market."
 
For more information on EVZIO, visit www.EVZIO.com
<http://www.evzio.com/> .
 
Conference Call for Media
Kaleo will host a briefing for members of the media on Thursday, April
3, 2014, at 12 p.m. ET. Media can call 1-888-771-4371, confirmation
number 37036155. The panel of speakers will include:
 
* Spencer Williamson, CEO of kaleo
* Eric Edwards, MD, PhD, Chief Medical Officer of kaleo
* Allen Burton, MD, anesthesiologist and pain specialist
* Knox H. Todd, MD, MPH, FACEP, emergency physician
 
About Opioid Overdose
Opioid overdose can cause a person's breathing to severely slow down and
even stop. Opioid medications have a relatively narrow therapeutic
window, meaning that even small changes - such as a single extra dose or
the addition of a small amount of alcohol - can cause a potentially
fatal overdose.8
 
Some risk factors for overdose include: history of substance abuse or
dependence, taking high doses of opioids,6 no previous history of taking
opioids,9 a recent dosage increase, extended-release or long-acting
opioids,10 taking certain antidepressants like monoamine oxidase
inhibitors (MAOIs) or certain drugs for anxiety, and a history of
respiratory conditions such as asthma, COPD and sleep apnea.6 In
addition, children living with someone consuming prescription opioids
have been shown to be at increased risk.11
 
Signs and symptoms of opioid overdose include very slow or absent
breathing, loss of consciousness, extremely small pupils, and slow
heartbeat.2
 
About EVZIO
EVZIO is a pre-filled, single-use auto-injector that works by
temporarily blocking the effect of an opioid, potentially reversing the
life-threatening respiratory depression and allowing the recipient to
breathe more regularly. Once the effects of EVZIO wear off, the overdose
symptoms may reappear and additional naloxone may be required. There is
no potential for abuse or dependence with naloxone.1
 
Each EVZIO delivers 0.4 mg naloxone hydrochloride injection (0.4 mL).
 
Indication
 
EVZIO is an opioid antagonist indicated for the emergency treatment of
known or suspected opioid overdose, as manifested by respiratory and/or
central nervous system depression.
 
EVZIO is intended for immediate administration as emergency therapy in
settings where opioids may be present.
 
EVZIO is not a substitute for emergency medical care.
 
Important Safety Information
 
The following is important safety information associated with dosing and
administration of EVZIO:
 
* EVZIO is for intramuscular or subcutaneous use only.
* Administer EVZIO to adult or pediatric patients into the
anterolateral aspect of the thigh, through clothing if necessary.
* In pediatric patients under the age of one, the caregiver should
pinch the thigh muscle while administering EVZIO.
* Seek emergency medical care immediately after use.
* The duration of action of most opioids is likely to exceed that
of EVZIO resulting in a return of respiratory and/or central nervous
system depression. Keep the patient under continued surveillance and
repeated doses of EVZIO should be administered every 2 to 3 minutes, as
necessary, while awaiting emergency medical assistance.
* If the electronic voice instruction system does not operate
properly, EVZIO will still deliver the intended dose of naloxone
hydrochloride when used according to the printed instructions on the
flat surface of its label.
 
The following precautions should be taken when administering EVZIO:
 
* Consider other supportive and/or resuscitative measures while
awaiting emergency medical assistance.
* Reversal of respiratory depression by partial agonists or mixed
agonists/antagonists such as buprenorphine and pentazocine, may be
incomplete or require higher doses of naloxone.
* Use in patients who are opioid dependent may precipitate acute
abstinence syndrome.
* In neonates, opioid withdrawal may be life-threatening if not
recognized and properly treated.
* Patients with pre-existing cardiac disease or patients who have
received medications with potential adverse cardiovascular effects
should be monitored in an appropriate healthcare setting.
* EVZIO should be used with caution in patients known to be
hypersensitive to naloxone hydrochloride.
 
Opioid Withdrawal:
Abrupt reversal of opioid effects in persons who were physically
dependent on opioids has precipitated signs and symptoms of opioid
withdrawal including: body aches, fever, sweating, runny nose, sneezing,
piloerection, yawning, weakness, shivering or trembling, nervousness,
restlessness or irritability, diarrhea, nausea or vomiting, abdominal
cramps, increased blood pressure, tachycardia. In the neonate, opioid
withdrawal signs and symptoms also included: convulsions, excessive
crying, hyperactive reflexes.
 
Use in Post-Operative Settings:
The following adverse reactions have been identified during use of
naloxone hydrochloride in the post-operative setting: hypotension,
hypertension, ventricular tachycardia and fibrillation, dyspnea,
pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy
have been reported as sequelae of these events. Excessive doses of
naloxone hydrochloride in post-operative patients have resulted in
significant reversal of analgesia and has caused agitation.
 
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please
click here <http://www.evzio.com/> for full Prescribing Information.
 
About kaleo
Kaleo (formerly Intelliject) is a pharmaceutical company dedicated to
putting a new generation of life-saving personal medical products in
patients' hands. The company's first product, Auvi-Q(tm) (www.Auvi-Q.com
<http://www.auvi-q.com/> ) (Allerject(tm) in Canada), was licensed to
Sanofi US which launched the product in early 2013. Our mission is to
provide demonstrably superior medical products that empower patients and
caregivers to confidently take control in potentially life-threatening
situations. We believe patients and caregivers are the experts on how
their medical condition impacts their lives, and are an integral part of
our product development process. Each kaleo product combines an
established drug with an innovative delivery platform with the goal of
achieving superiority and cost effectiveness. Kaleo is a privately held
company headquartered in Richmond, Virginia. For more information, visit
www.kaleopharma.com <http://www.kaleopharma.com/> .
 
(c)2014 kaleo, Inc. All rights reserved. PP-EVZ-US-0016 April 2014
 

 
1 EVZIO Prescribing Information. 2014.
 
2 SAMHSA Opioid Overdose Prevention Toolkit Safety Advice for Patients.
HHS Publication No. (SMA) 13-4742.
 
3 Institute of Medicine. Relieving Pain in America A Blueprint for
Transforming Prevention, Care, Education, and Research. June 2011.
 
4 National Center for Health Statistics. NCHS data on drug poisoning
deaths.
http://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.pdf.
Updated December 2012
 
5 Centers for Disease Control and Prevention. Opioid-related deaths
continue to increase.
http://media.jsonline.com/images/OPIOIDS20GFIX.jpg.
 
6 Leavitt, S. Intranasal Naloxone for At-Home Opioid Rescue. Practical
Pain Management. Oct 2013.
 
7 Editor's Note: Dr. Burton has a consulting agreement with kaleo, Inc.
 
8 Boyer, E. Management of Opioid Analgesic Overdose. N Engl J Med 2012;
367
 
9 Manchikanti, L. Opioid Epidemic in the United States. Pain Physician.
2012;15;ES9-ES38.
 
10 Food and Drug Administration. FDA blueprint for prescriber education
for extended-release and long-acting opioid analgesics.
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/
document/ucm277916.pdf. Published 2013
 
11 Burghardt, L. et al. Pediatrics. Adult Prescription Drug Use and Ped.
Medication Exposure 2013
 

 
SOURCE Kaleo
 

 

 

 
Alice Bell, L.C.S.W.
 
Overdose Prevention Project Coordinator
 
Prevention Point Pittsburgh
 
907 West Street, 5th Floor
 
Pittsburgh, PA 15221
 
412-247-3404
 
ab...@pppgh.org
 

 

 

 

 

 

 
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