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Too little, too late? FDA approves naloxone auto-injector in the wake of Zohydro

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Today, the FDA announced the approval of a new hand-held auto-injector to remediate opioid overdoses. Marketed as Evzio, the device contains naloxone hydrochloride for intramuscular or subcutaneous injection. Prior to the fast-tracked approval of Evzio, overdoses were usually treated with syringe-based injections of naloxone.

In a press announcement released virtually simultaneously with the Evzio announcement, FDA Commissioner Margaret Hamburg echoed Massachusetts Governor Deval Patrick by stating that the United States has a serious problem with opioid abuse. Despite the FDA's public stance questioning Governor Patrick's restrictions on Zohydro prescriptions in Massachusetts, the agency acknowledges that "drug overdose deaths [have] steadily increased for more than a decade." Commissioner Hamburg herself admits that "more than 16,000 lives are lost each year due to opioid-related overdoses." However, she appears to believe that clearly worded dosage instructions and readily available overdose-reversal agents are the answer to America's problem with opioids.

Evzio, approved under the FDA's "priority review" program, was tested for efficacy in 30 patients. The drug-device combination was approved more swiftly than anticipated, beating the projected date of June 20, 2014, by nearly three months. According to Commissioner Hamburg, "We [...] all need to work together to invest in strategies [...] that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most." However, the Mayo Clinic warns that "Pain medications often aren't effective in reducing chronic pain, and sometimes they may result in drug dependence or cause side effects that can make pain worse." It is unclear whether the increased nationwide availability of non-abuse-deterrent opioids such as Zohydro combined with the promise of overdose-reversal agents such as Evzio outside a clinical setting will improve the opioid abuse situation in the United States or just make it worse.

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