NAPSR News: Purdue Pharma Receives FDA Approval for Hysingla ER (hydrocodone bitartrate)

WASHINGTON - Nov. 21, 2014 - PRLog -- The U.S Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate) manufactured by Purdue Pharma to treat chronic pain administered once-daily in the form of extended-release tablets CII using Purdue’s proprietary extended-release solid oral platform, RESISTEC^™. Hysingla ER has been recognized by the FDA as having abuse-deterrent properties, expected to discourage the abuse of the medication via chewing, snorting and injection. Hysingla ER does not contain acetaminophen which is the leading cause of acute liver failure in the United States due to overuse. Medications containing hydrocodone and acetaminophen are among the most widely abused prescription products in the United States and is also the most prescribed. Hysingla ER is specifically intended to treat patients who do not respond well to alternative treatment options for severe pain and require daily, continuous, long-term opioid treatment. The drug is not indicated as an as-needed analgesic.

“The burden of chronic pain and the abuse of prescription medications are both pressing societal problems,” said Charles E. Argoff, MD, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York. “Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications. Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis.”

Purdue Pharma foresees a U.S. launch date for Hysingla ER in early 2015 in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg to be taken once every 24 hours.

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