Generic Opioid Overdose Antidote Treatment to be Available in 2019

DECEMBER 13, 2018
An authorized generic for kaléo’s naloxone HCl injection (Evzio®) will be availabile midyear in 2019, and will come with a list price of $178 per carton, each containing 2 auto-injectors. Offered through kaléo subsidiary IJ Therapeutics, the new authorized generic is the same formulation and design as the branded drug, but will have a different label.

Naloxone 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. Naloxone is used to temporarily reverse the effects of opioid medicines, but does not take the place of emergency medical care.

"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, in a prepared statement. "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 health care system.”

According to kaléo, its naloxone HCl injection is the only FDA-approved naloxone auto-injector with voice and visual guidance that talks the user step by step through the administration of the drug to reverse the effects of an opioid overdose. However, this treatment is not a substitute for emergency medical care, and its use may result in symptoms of acute opioid withdrawal.

Kaléo will continue to market and distribute Evzio, for which new Public Access Pricing is being introduced, the company announced in a statement. Government agencies, first responders, health departments and other qualifying groups will be eligible to obtain the brand name treatment for $178 for 2 auto-injectors when they purchase directly from kaléo or authorized distributors. 

Although Evzio is currently 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.  

"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, in a prepared statement. "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."

Family members, caregivers, or other people who may have to use naloxone in an opioid emergency should know where the treatment is stored and how to administer it before an opioid emergency happens.

Serious adverse effects of naloxone include sudden opioid withdrawal symptoms, such as 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 of age who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Adverse effects include seizures, crying more than usual, and increased reflexes.

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


Reference

Authorized Generic for EVZIO® (naloxone HCl injection) to be Available at a Reduced List Price of $178 [news release]. Richmond, VA; December 12, 2018: Kaléo. https://prnmedia.prnewswire.com/news-releases/authorized-generic-for-evzio-naloxone-hcl-injection-to-be-available-at-a-reduced-list-price-of-178-300763797.html?c=n&rel=0" . Accessed December 12, 2018. 

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