Thursday, March 20, 2014

OxyContin Manufacturer Tests Tamper-Resistant Form of Hydrocodone

By Join Together Staff | March 18, 2014 | Leave a comment | Filed in Prescription Drugs & Prevention

The maker of OxyContin announced promising results from a study of a tamper-resistant form of hydrocodone, The Washington Post reports. The Food and Drug Administration (FDA) has been criticized for approving Zohydro ER (extended release), a pure form of hydrocodone that is not tamper-resistant.

Purdue Pharma, which manufactures OxyContin, said it will soon seek FDA approval for its version of an extended-release form of hydrocodone. The company says its version is difficult for a person to crush, in order to inject or snort the drug. In 2010, the company reformulated OxyContin to make it harder to crush or dissolve.

The new study showed a majority of patients with chronic low back pain treated once daily with the hydrocodone drug experienced at least a 30 percent improvement in pain intensity, compared with a placebo. Almost half achieved a 50 percent improvement.

“This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers,” Gary L. Stiles, the company’s Senior Vice President of Research and Development, said in a statement.

Last week, West Virginia Senator Joe Manchin called on Health and Human Services Secretary Kathleen Sebelius to overrule the FDA decision to approve Zohydro ER. Late last year, Manchin and three other senators wrote to the FDA, saying they disagreed with the agency’s decision to approve the drug. In October, the FDA approved Zohydro for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen.

In December, the attorneys general from 28 states asked the FDA to reassess its decision to approve Zohydro.

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