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Fast-tracked product is acclaimed by FDA as well as its developer, Kaléo
On a not-serious level, one can ask, ‘Why didn’t I think of that?’ But on another, much more serious level, there’s news from FDA and Kaléo (Richmond, VA) that could lead—very quickly—to saving lives and providing some good news in the generally grim topic of opioid abuse. On Apr. 3, FDA announced approval of a new drug-device combination, Kaléo’s Evzio auto-injector, to provide treatment of patients in an opioid-overdose emergency. Somewhat like an epinephrine auto-injector (a product that Kaléo also developed—marketed by Sanofi-Aventis—as the Auvi-Q auto-injector), a family member, emergency medical technician or other healthcare provider can administer a dose of naloxone, which counters the depressive effects of opioids on patients’ nervous and respiratory systems.
Naloxone, a generic, has been around for decades. In recent years, there has been a swelling demand for making it more broadly available to treat opioid overdoses (which can occur both through drug abuse and through patients over-medicating themselves). The death statistics are stark: well over 16,000 Americans die annually from opioid abuse. There are now “naloxone clinics” to make the drug more broadly available; numerous states have passed laws to enable physicians and pharmacists to fill prescriptions for caregivers on behalf of an opioid abuser.
Kaléo’s product combines its auto-injector with audio instructions on proper administration, once the device is powered up. The dose is delivered in an intramuscular or subcutaneous fashion. Existing naloxone dosages are in syringes that require training to use properly; some public health sites also give instructions for an off-label intranasal administration.
FDA gave Evzio fast-track approval status. In an unusual step for a drug approval, the announcement was made by FDA Commissioner Margaret Hamburg, who said, “Today’s FDA approval of Evzio provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks.”
The product will be in retail pharmacies this June, says Spencer Williamson, Kaléo CEO. Just after the FDA announcement, Kaléo also revealed that it has arranged $150 million in debt financing with PDL Biopharma Inc. (Incline Village, NV), which specializes in “royalty monetization” financing (i.e., based on future sales of a product). Williamson says that the financing will be used to fund commercialization of Evzio with a sales force and marketing program. Manufacturing is already being handled by contract providers. While Evzio’s commercial success is not assured, it’s hard to think of a comparable innovation, identifying a market need and making use of a generic product, smart packaging and the latest microelectronic technology to save lives.