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EVZIO™ (naloxone HCl injection) Auto-Injector Now Available in the United States for the Emergency Treatment of Opioid Overdose

First and only FDA approved naloxone product specifically indicated for emergency therapy in settings where opioids may be present.

Kaléo, a privately-held pharmaceutical company headquartered in Richmond, Virginia, today announced the United States (U.S.) commercial availability of EVZIO for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. EVZIO is not a substitute for emergency medical care. EVZIO, approved by the U.S. Food and Drug Administration (FDA) on April 3, 2014, is the first and only naloxone product labeled for immediate administration by family members or caregivers.¹

“Opioid overdose is a significant and growing public health concern in America and until now, there have been limited options available for the rapid administration of this potentially life-saving drug in non-healthcare settings,” said Spencer Williamson, CEO of Kaléo. “We are pleased to be able to make EVZIO available soon after receiving approval by the FDA.”

EVZIO is now available in the United States by 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. After administering EVZIO, emergency medical care should be immediately sought.

“EVZIO is the first and only FDA approved naloxone auto-injector specifically designed to be used by individuals without medical training,” said Evan Edwards, Kaléo’s Vice President of Product Development. “Additionally, using Kaléo’s comprehensive human factors engineering process, EVZIO was designed and validated for use by family members and caregivers.”

To better serve patients, Kaléo offers patient assistance and savings programs through Kaléo Cares. For more information about Kaléo Cares, please visit kaleo.com/who-we-are/kaleo-cares/

About EVZIO

EVZIO is a pre-filled, single-use, hand-held 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. Each EVZIO delivers a single 0.4 mg dose of naloxone HCl injection. Since the duration of action of most opioids may exceed that of naloxone, seek immediate emergency medical assistance, keep the patient under continued surveillance, and administer repeated doses of EVZIO as necessary. 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 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 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 Opioid Overdose

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.² Opioids are used to treat pain associated with a variety of acute and chronic medical conditions. Nearly 17,000 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.^3,4 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.⁵

Some risk factors for overdose include: history of substance abuse or dependence, taking high doses of opioids, no previous history of taking opioids,⁶ a recent dosage increase, extended-release or long-acting opioids,⁷ 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.⁸

Signs and symptoms of opioid overdose include very slow or absent breathing, loss of consciousness, extremely small pupils, and slow heartbeat.²

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.¹ 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.

¹ EVZIO Prescribing Information. kaleo, Inc. 2014.

² Institute of Medicine. Relieving Pain in America A Blueprint for Transforming Prevention, Care, Education, and Research. June 2011.

³ Paulozzi, L.J., Mack, K.A., and Hockenberry, J.M. Vital Signs: Variation Among States in Prescribing of Opioid Pain Relievers and Benzodiazepines — United States, 2012. July 4, 2014 / 63(26);563-568. Accessed July 1, 2014, this as an MMWR Early Release on http://www.cdc.gov/mmwr.

⁴ Centers for Disease Control and Prevention. Opioid-related deaths continue to increase. http://media.jsonline.com/images/OPIOIDS20GFIX.jpg.

⁵ Boyer, E. Management of Opioid Analgesic Overdose. N Engl J Med 2012; 367.

⁶ Manchikanti, L. Opioid Epidemic in the United States. Pain Physician. 2012;15;ES9-ES38.

⁷ 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.

⁸ Burghardt, L. et al. Pediatrics. Adult Prescription Drug Use and Ped. Medication Exposure 2013.