News

Police Reverse First Opioid Overdose Using EVZIO® (naloxone HCl injection) Provided through Kaléo Cares Donation Program

— Law Enforcement Officers in 13 States Now Carrying EVZIO —

Richmond, Va. (January 15, 2015) – Kaléo, a privately-held pharmaceutical company, today announced the first opioid overdose reversed by police officers using the EVZIO® naloxone auto-injector, since launching the Kaléo Cares donation program in November, 2014. Through this initiative, Kaléo has donated EVZIO naloxone auto-injectors to local law enforcement agencies and community organizations throughout the United States.

On Christmas Day, police officers in Deerfield, Illinois successfully administered EVZIO to help save the life of an opioid overdose victim. “Using the auto-injector made it easy for responding officers to administer naloxone at the scene, helping to revive the woman before emergency responders arrived to take her to the hospital,” said Deerfield Deputy Police Chief Tom Keane. “We’re in the business of saving lives, and it feels good to have the right tool to help get the job done. We are making EVZIO a standard part of the First Aid to-go bags that our officers carry.” The officers were trained to recognize the signs of an opioid overdose and how to administer emergency treatment by the Lake County Health Department.

EVZIO is the first and only naloxone product approved for immediate administration as emergency therapy in any setting where opioids may be present, including outside of supervised medical settings. Voice and visual cues that assist in guiding a user through the injection process make it easy to use by family members or caregivers with little or no training.

“As we saw in Deerfield, the quick administration of naloxone has the potential to save lives in an opioid overdose emergency,” said Spencer Williamson, CEO of Kaléo. “Kaléo is committed to saving lives, and we are proud that through our program a first responder had access to EVZIO when it mattered most.”
When an opioid overdose occurs, it can cause a person’s breathing to severely slow down and even stop. Although not a substitute for emergency medical care, the immediate use of EVZIO may temporarily block the effects of an opioid, potentially reversing this life-threatening respiratory depression to help keep a patient breathing until medical assistance is available.

In addition to donations made to law enforcement agencies, the Kaléo Cares program has donated EVZIO auto-injectors to local community organizations in eight states, such as the Harm Reduction Coalition, an organization aimed at fighting opioid addiction and overdose.

“The EVZIO naloxone auto-injectors donated to the Harm Reduction Coalition made a huge impact in our community here in Austin,” said Mark Kinzly, a member of the board of directors for the Harm Reduction Coalition of Austin, Texas. “Success lies not in what others consider great, but in doing what is right. Thank you Kaléo for doing what is right.”

For more information about the Kaléo Cares program, please visit kaleo.com/who-we-are/kaleo-cares/.

About Overdose and Opioid-Induced Respiratory Depression (OIRD)

Overdose and Opioid-Induced Respiratory Depression is a growing public health epidemic. In addition to the surge in heroin deaths, forty-four people die from prescription opioid overdoses in the United States each day. (1) Life-threatening Opioid-Induced Respiratory Depression (OIRD) is the most important serious adverse effect of opioids. Approximately 136,000 opioid overdose emergency department visits occur each year.(2) On average, 3,300 children five years old and younger are admitted to emergency departments each year due to accidental opioid exposure.(3)

There are a number of risk factors for patients taking opioids that may increase the potential for life-threatening OIRD and opioid overdose. Even when taking the prescribed dose of an opioid as directed, individuals may be at increased risk of OIRD if taking high doses, taking an opioid in combination with other drugs (e.g., benzodiazepines) or alcohol, or if they have a history of certain medical conditions (e.g., COPD, asthma).(4,5,6,7) Seconds count when a suspected life-threatening OIRD or overdose event occurs. Without rapid intervention, brain injury or death can occur within minutes.(8) Most life-threatening opioid emergencies occur in the home and are witnessed by family and friends who may be in the best position to intervene quickly.(9)

About EVZIO

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 and is available in the U.S. by prescription. EVZIO is the only FDA-approved naloxone for immediate administration as emergency therapy in settings where opioids may be present, such as in the home, and may be used by family members and caregivers with little or no training. EVZIO is not a substitute for emergency medical care. Each EVZIO pre-filled, single-use, hand-held auto-injector delivers a single 0.4 mg dose of naloxone HCl injection. Each EVZIO prescription comes with two auto-injectors and a trainer.

For more information on EVZIO, visit www.EVZIO.com.

Important Safety Information

EVZIO is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the ingredients in EVZIO.
The following warnings and precautions should be taken when administering EVZIO:

• Due to the duration of action, keep the patient under continued surveillance and repeated doses of naloxone should be administered, as necessary, while awaiting emergency medical assistance.

• Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

• Reversal of respiratory depression by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete.

• Use in patients who are opioid dependent may precipitate acute abstinence syndrome.

• 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.

• In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.

The following adverse reactions have been identified during use of naloxone hydrochloride in the postoperative 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 postoperative patients have resulted in significant reversal of analgesia and have caused agitation.

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, and tachycardia. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes.

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 for full Prescribing Information.

About Kaléo

Kaléo is a pharmaceutical company dedicated to putting a new generation of life-saving personal medical products in patients’ hands. On April 3, 2014, the FDA approved EVZIO, the first and only naloxone product labeled for immediate administration by family members or caregivers as emergency therapy for the treatment of known or suspected opioid overdose. The company’s first product approval, Auvi-Q® (www.Auvi-Q.com) (Allerject® in Canada), was licensed to Sanofi 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 Kaléo product combines an established drug with an innovative delivery platform with the goal of achieving superiority and cost effectiveness. Kaléo is a privately-held company headquartered in Richmond, Virginia.

For more information, visit kaleo.com.

Citations:

1. Centers for Disease Control and Prevention (2015). Deaths: Final data for 2013. National vital statistics reports; vol 64 no 2. Hyattsville, MD: National Center for Health Statistics. http://www.cdc.gov/nchs/data/nvsr/nvsr64/nvsr64_02.pdf. Accessed January 12, 2015.

2. Yokell et al. Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency Departments. JAMA Intern Med. 2014;174(12):2034-2037.

3. Burghardt L, et al. Pediatrics. 2013;132:18-27.

4. Bohnert A, et al. JAMA. 2011;305:1315-1321.

5. Madadi P, et al. PLoS One. 2013;8:e60600.

6. Paulozzi L. Et al. Addiction. 2009;104:1541-1548.

7. Green T, et al. Drug Alcohol Depend. 2011;115:221-228.

8. Smith, Nathalie. Anoxic Brain Damage. 2011 EBSCO Publishing. http://www.med.nyu.edu/content?ChunkIID=96472. Accessed January 12, 2015.

9. World Health Organization (2014). Community Management of Opioid Overdose. http://www.who.int/substance_abuse/publications/management_opioid_overdose/en/