Yesterday, the FDA approved Evzio, a hand-held device that delivers a single dose of naloxone, which reverses the effects of opioid overdose such as stopped breathing and lost consciousness. When used during the one to three hour window after someone has overdosed, naloxone can reverse the binding of the opioid drug to certain receptors in the brain that control breathing. The approval took a short 15 weeks, and the product is expected to be available this summer. Currently, naxalone treatment is available mostly in hospitals and other medical settings, and naxalone treatment outside of a medical setting can require assembly (e.g., syringes, vials, nasal spray attachments). The hand-held device is the shape of a credit card and the thickness of a cellphone, small enough to fit in one’s pocket or a medicine cabinet. It provides verbal instructions on how to administer the drug and uses a retractable needle, no assembly needed. Evzio also created a training device people can use to practice using the product.
Those in favor of the FDA’s decision believe that the new device, when widely disseminated, can help prevent the growing number of fatal opioid overdoses. The most recent data shows that in 2010, 16,651 people died from opioid overdoses in the US. Others have criticized the FDA for not focusing on the bigger issues, e.g., preventing inappropriate prescribing or the controversial approval of Zohydro, and instead approving an device that could encourage opioid abusers act irresponsibly.