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FDA Approves New Abuse-Deterrent Painkiller; CDC Reports on Deaths from Opioid Overdoses

FDA Approves New Abuse Deterrent OpioidThe FDA has approved a new opioid, Hysingla ER (hydrocodone bitartrate), for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

Hysingla joins a small but growing list of extended release opioids that are specifically formulated to prevent abuse. These include the new combo drug Targiniq (oxycodone and naloxone), approved in July 2014, along with Oxyctonin CII (oxycodone hydrochloride controlled-release) and Embeda CII (morphine sulfate and naltrexone hydrochloride), for which abuse-deterrent labeling was approved in April 2013 and October 2014, respectively.

Hysingla tablets are designed in a way that makes them very difficult to crush and dissolve. This reduces the risk of abuse by injection (the contents of the pill won’t liquefy, but rather turns to a thick gel), snorting, or chewing.

However, the FDA is quick to point out, Hysingla is not completely impossible to misuse or abuse. And all opioids carry the risk of accidental or intentional overdose leading to severe injury or death. But Hysingla is certainly a lot harder to abuse than typical short-acting opioids like morphine, hydromorphone, and oxycodone. Immediate-release medications containing hydromorphone are among the most abused.

At its highest dose, a single Hysingla pill contains 120 mg of hydromorphone and is only taken once daily. This is 15 times the highest dose available per immediate-release tablet of generic hydromorphone. Hysingla is also available in 20, 30, 40, 60, 80, and 100 mg tablets. The manufacturer of Hysingla, Purdue Pharma, produces a number of other pain management medications including Dilaudid (hydromorphone), Oxycontin CII, and MS Contin (extended-release morphine).

Hysingla is the second extended-release hydromorphone medication approved in just over a year. The other, Zohydro, was met with heavy resistance from the drug treatment community and some physicians because it does not have abuse deterrent properties. Perhaps as a result, Zohydro has not become a go-to drug for many prescribers. In fact, in the month of July 2014, Zohydro accounted for only 0.23% of extended-released opioid prescriptions and only 0.02% of any opioid prescription, according to data presented by the FDA’s Janet Woodcock on their blog FDA Voice. Zogenix, the manufacturer of Zohydro, applied to the FDA for approval of an abuse deterrent version of the drug in October 2014.

Meanwhile, this week the Centers for Disease Control and Prevention (CDC) released a report detailing just how big of a problem prescription opioid abuse has become. According to Trends in Drug-poisoning Deaths Involving Opioid Analgesics and Heroin: United States, 1999–2012, between 1999 and 2012, drug poisoning deaths from prescription painkillers more than tripled, from 1.4 per 100,000 in 1999 to 5.1 in 2012. However, there was a small 5% decline in these deaths between 2011 and 2012, the first decrease in more than a decade.

More information on Hysingla and the FDA’s abuse-deterrent opioid program can be found on the FDA website.

 

Image courtesy of holohololand at FreeDigitalPhotos.net

 

FDA Approves New Abuse-Deterrent Painkiller; CDC Reports on Deaths from Opioid Overdoses