Drug, hard to abuse, approved

WASHINGTON - Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized as lacking such safeguards.

The Food and Drug Administration approved Purdue Pharma's Hysingla ER, for patients with severe, round-the-clock pain that cannot be managed with other treatments. The once-a-day tablet is designed to thwart abuse via chewing, crushing, snorting, or injecting. The tablet is difficult to crush, break or dissolve, and forms a thick gel when tampered with that discourages injecting.

Hysingla is only the fourth drug ever approved by the agency with claims that it discourages abuse and tampering. Purdue markets two of the other drugs, including a crush-resistant version of its oxycodone pill, OxyContin, and a combination pill, Targinigiq, which includes an extra ingredient designed to block the effects of oxycodone if the tablet is crushed.

These drugs, along with Hysingla, can still be abused when swallowed intact - the most common method for abusing painkillers.

Hysingla poses a direct commercial challenge to Zogenix's much-debated drug Zohydro, a twice-a-day hydrocodone tablet approved by the FDA last year.

Doctors prescribe opioids for a range of ailments, from postsurgical pain to arthritis and migraines. Deaths linked to abuse of the medications have quadrupled since 1990 to nearly 17,000 annually, according to the Centers for Disease Control and Prevention.

Medical experts disagree over the appropriate role of opioids in treating pain, with some arguing that they should only be used for the most severe cases, such as cancer pain or end-of-life care.

The FDA has been under intense public pressure to combat the national epidemic of prescription opioid abuse.

The agency's approval of Zohydro last year prompted a wave of criticism from elected officials, law enforcement and anti-addiction groups who said that the pill should have been reformulated to discourage abuse. The extended-release painkiller was the first FDA-approved pure form of hydrocodone, the most abused prescription drug ingredient in the country. Previously hydrocodone was only available in lower-dose combination pills like Vicodin.