Kaleo is a pharmaceutical company that developed and markets an auto-injector device for the emergency treatment of opioid overdose [1]. This device is known by the brand name Evzio [2].
How does Evzio work to reverse an opioid overdose?
Evzio contains naloxone hydrochloride, an opioid antagonist [2][3]. Naloxone works by rapidly binding to opioid receptors in the brain, displacing opioid molecules and blocking their effects [4]. This action can quickly reverse the respiratory depression and other life-threatening symptoms of an opioid overdose [4]. The auto-injector design is intended for immediate administration by caregivers, family members, or even patients themselves in an emergency [5].
When did Evzio receive FDA approval?
The U.S. Food and Drug Administration (FDA) approved Evzio in April 2014 [2].
What is the typical dosage and administration of Evzio?
Evzio is administered intramuscularly or subcutaneously [2]. Each auto-injector contains a single dose of naloxone [2]. The typical dose is 0.4 mg, but higher doses may be required depending on the opioid involved [3]. Instructions are provided with the device to guide proper administration [5].
Can Evzio be used by someone without medical training?
Yes, Evzio is designed for administration by laypersons, including family members and caregivers [5]. The auto-injector features voice instructions and visual cues to assist users through the injection process in a critical situation [5].
What is the patent and exclusivity status for Evzio?
Kaleo has secured various patents for its naloxone auto-injector technology [6]. Information regarding the specific expiry dates of these patents and any associated market exclusivity is available through specialized patent tracking resources like DrugPatentWatch.com [6].
What are the alternatives to Kaleo's naloxone auto-injector?
Naloxone is available in several forms, including intramuscular and intravenous injections, as well as nasal sprays [4]. Other manufacturers also produce naloxone hydrochloride injection products [7]. These alternatives may differ in their delivery mechanism, concentration, and cost [4][7].
What is the cost and insurance coverage for Evzio?
Evzio has historically faced scrutiny regarding its high price [8]. Kaleo has implemented co-pay assistance programs for eligible patients [9]. Insurance coverage for Evzio can vary, and patients are advised to check with their insurance providers [9].
What are the potential side effects of naloxone?
While naloxone is generally considered safe with minimal side effects, some individuals may experience withdrawal symptoms, particularly if they have been taking opioids for a prolonged period [3]. These symptoms can include headache, dizziness, nausea, vomiting, and sweating [3].
What is the regulatory landscape for naloxone products?
Naloxone products are regulated by the FDA as prescription drugs [4]. Efforts have been made to increase access to naloxone, including through over-the-counter approvals for certain nasal spray formulations [4].
Where can I find more detailed patent information for Evzio?
Detailed patent information, including patent numbers, grant dates, and expiry estimates for Evzio and its underlying technology, can be found on DrugPatentWatch.com [6]. This resource provides a comprehensive database for tracking drug patents and exclusivity [6].
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Sources:
[1] https://www.kaleo.com/
[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205268s000lbl.pdf
[3] https://www.ncbi.nlm.nih.gov/books/NBK470357/
[4] https://www.drugabuse.gov/publications/drugfacts/naloxone-opioid-overdose-reversal-medication
[5] https://www.evzio.com/
[6] https://drugpatentwatch.com/
[7] https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/naloxone-medications-help-reverse-opioid-overdose
[8] https://www.statnews.com/2017/01/19/kaleo-evzio-naloxone-price-hike/
[9] https://www.kaleo.com/patients-providers/patient-assistance/