Authorized Generic for EVZIO® (naloxone HCl injection) to be Available at a Reduced List Price of $178

- Product will be available in 2019

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Dec 12, 2018, 08:00 ET

RICHMOND, Va., Dec. 12, 2018 /PRNewswire/ -- Kaléo, a privately-held pharmaceutical company, today announced that it will offer an authorized generic of its EVZIO® (naloxone HCl injection) take home naloxone product at a list price of $178 per carton (each carton contains two auto-injectors).

Offered through kaléo subsidiary IJ Therapeutics, the authorized generic will be made available in midyear 2019 well in advance of EVZIO's patent expirations. The authorized generic for EVZIO is the same formulation, design and meets all of the same high standards of quality as the branded drug but will have a different label. Kaléo will continue to market and distribute EVZIO.

"With approximately 130 people dying daily from opioid overdoses, we recognize that more needs to be done to improve access for patients," said Spencer Williamson, President and CEO of kaléo. "We have been working for some time with the major pharmacy benefit managers and insurers to identify solutions for removing barriers and restrictions that may impede access. We are encouraged by these ongoing conversations and are confident that introducing an authorized generic is the most efficient way to provide greater coverage of a lower priced option -- with the least amount of disruption to the healthcare system," said Williamson.

EVZIO is the only FDA-approved naloxone auto-injector with voice and visual guidance that talks the user step by step through the administration of naloxone to reverse the effects of an opioid overdose. EVZIO is not a substitute for emergency medical care. The use of EVZIO may result in symptoms of acute opioid withdrawal.

Presently, EVZIO is available for $0 out-of-pocket to eligible patients with commercial insurance. The lower list price of the authorized generic will offer a more affordable and cost-effective solution for Medicare Part D patients and plans.

In addition, effective immediately, kaléo is introducing new Public Access Pricing for EVZIO of $178 per carton (two auto-injectors per carton, $89 per dose). Government agencies, first responders, health departments and other qualifying groups on the front lines of the nation's opioid overdose crisis are eligible for this price when they purchase directly from kaléo or authorized distributors.

"Kaléo remains committed to providing patients broad and affordable access to take-home naloxone. In fact, we developed the first ever take-home naloxone because we recognized the need for people with no medical training to have access to this potentially life-saving medicine in their homes as they are often the ones who witness opioid overdoses," said Omar Khalil, kaléo's General Manager for Addiction and Neurology. "Now, in recognition of the growing need for take-home naloxone and by taking these steps, we can help provide even greater access to patients, care partners, clinicians, first responders and other key members of the community dedicated to tackling this tragic crisis."

Patients, their families and care providers can get information about how to obtain EVZIO or learn more about the EVZIO patient access program which provides EVZIO free to qualified patients, by visiting EVZIO.com.

About kaléo (kuh-LAY-oh)
Kaléo is a new type of pharmaceutical company, dedicated to building innovative solutions for serious and life-threatening medical conditions. 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. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit www.kaleo.com.

INDICATION
EVZIO is a prescription medicine used in adults and children for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond. EVZIO is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of EVZIO, even if the person wakes up. EVZIO is safe and effective in children for known or suspected opioid overdose.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about EVZIO?
EVZIO is used to temporarily reverse the effects of opioid medicines. The medicine in EVZIO has no effect in people who are not taking opioid medicines. Always carry EVZIO with you in case of an opioid emergency.

Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:

unusual sleepiness and you are not able to awaken the person with a loud voice or rubbing firmly on the middle of their chest (sternum)
breathing problems including slow or shallow breathing in someone difficult to awaken or they look 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 EVZIO in an opioid emergency should know where EVZIO is stored and how to give EVZIO before an opioid emergency happens.

Get emergency medical help right away after using the first dose of EVZIO. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.

The signs and symptoms of an opioid emergency can return within several minutes after EVZIO is given. If this happens, give additional injections using new EVZIO auto-injectors every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

Who should not use EVZIO?

Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in EVZIO.

What are the ingredients in EVZIO?

Active ingredient: naloxone hydrochloride
Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water

What should I tell my healthcare provider before using EVZIO?

Tell your healthcare provider about all of your medical conditions, including if you:

have heart problems, are pregnant or plan to become pregnant. Use of EVZIO may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you are given EVZIO.

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of EVZIO?

EVZIO may cause serious side effects, including:

Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving EVZIO and may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, and increased heart rate.

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.

Common side effects of EVZIO include dizziness and injection site redness.

These are not all of the possible side effects of EVZIO. Call your doctor for medical advice about side effects. 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 to see the full Prescribing Information and the Patient Information or visit www.evzio.com.