Rapid Opioid Countermeasure System (ROCS)

Naloxone Auto-Injector 10 mg is an opioid antagonist indicated for use by military personnel and chemical incident responders for:¹

Emergency treatment of patients 12 years of age and older where use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.
Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.

Market Leader In Emergency Use Auto-Injectors

Six Food and Drug Administration auto-injector product approvals
Millions of gas-powered auto-injectors manufactured; demonstrated in-market success

Delivery Platform Excellence

Meets Food and Drug Administration draft guidance standard for 99.999% device reliability
Naloxone Auto-Injector 10 mg passes Department of Defense military standard durability tests

Example Use Case Scenarios

Kaléo intends this device to be useful in protecting civilians and government employees who may come in contact with ultra-potent opioids in the fulfillment of their duties or during a mass casualty event.

Military environment with weaponized opioids
Domestic terrorist attack using weaponized opioids
Illicit drug production facilities with aerosolized opioids
Land-based or maritime drug interdiction for mass quantity opioid exposure

Naloxone Auto-Injector 10 mg can be administered through clothing, including personal protective equipment such as MOPP4. Removal of personal protective equipment is not required.

Instructions for Use

STEP 1

Firmly pull the auto-injector from the outer case.

STEP 2

Pull off the red safety guard.

STEP 3

Place the black end of the auto-injector against the outer thigh, through clothing or personal protective equipment equipment (including MOPP4 PPE), if needed. Press firmly until you hear a click and hiss and hold in place for 5 seconds.

NOTE: After administering the first dose of Naloxone Auto-Injector 10 mg, get emergency medical help right away.²

Usability & Simulated Real-World Use Scenarios

Two human factor validation studies were conducted to validate the user interface of Naloxone Auto-Injector 10 mg for law enforcement officers, emergency medical services personnel, and military personnel using simulated use scenarios and post-simulation interviews. Overall, all seventy-five participants were able to successfully deliver a simulated Naloxone Auto-Injector 10 mg dose to either a victim or themselves and answered all critical knowledge task questions correctly.

Sixty Law Enforcement & Emergency Medical Services Personnel

Untrained participants – half of whom where experienced with a trainer for a similar auto-injector – were instructed to administer Naloxone Auto-Injector 10 mg to an opioid overdose victim (manikin) in a simulated sports bar/recreational area.

The testing environment included variables aimed at inducing stress (e.g., low lighting, flashing disco lights, loud music, beeping that increased in frequency and loudness, live patron bystanders).

Fifteen Military Personnel

A week after instructor-led training on Naloxone Auto-Injector 10 mg use, participants were asked to don MOPP4 and administer Naloxone Auto-Injector 10 mg to an unconscious soldier (manakin also wearing personal protective equipment) and themselves (due to a breach in personal protective equipment) in a simulated scenario where a high-potency opioid had been released in a populated area.

In addition to the challenges inherent with MOPP Level 4 (e.g., impaired dexterity, tactility, visibility), environmental challenges included emergency sirens/alarms, fog, darkness, flashing emergency lights, crowded space, multiple casualties, and beeping that increased in frequency/loudness.

IMPORTANT SAFETY INFORMATION

Contraindications, Warnings, Precautions, and Adverse Events

NAI 10 mg is contraindicated in individuals with hypersensitivity to naloxone hydrochloride or to any of the other ingredients in NAI 10 mg.
Use in patients who are opioid dependent may cause abrupt opioid withdrawal. Use of a product that delivers a dose lower than 10 mg of naloxone HCl may be preferable in treatment of a patient with known opioid dependence.
Due to the duration of action of naloxone HCl relative to the opioid, keep the patient under continued surveillance and administer additional naloxone HCl, as necessary, while awaiting emergency medical assistance.
The following adverse reactions were observed in more than one subject in clinical studies evaluating NAI: dizziness, feeling hot, headache, and injection site erythema.

References