FDA Approves New Extended-Release, Abuse-Deterrent Hydrocodone
The FDA has approved Hysingla ER, a once-daily, single-entity hydrocodone product. What makes Hysingla ER unique is that it is the first and so far the only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected.
You may remember that the approval of Zohydro ER just over a year ago triggered a firestorm of controversy. Zohydro ER was the first extended-release hydrocodone product to be approved and it was also the first hydrocodone product not to be combined with another weaker pain reliever like acetaminophen, ibuprofen or aspirin, which can damage the liver and/or stomach. The main complaint was that Zohydro ER was not an abuse-deterrent formulation.
Hysingla ER solves that problem and will hopefully be more accepted by the medical community as well as other government entities. Manufactured by Purdue Pharma L.P., Hysingla ER is formulated using Purdue's proprietary extended-release solid oral platform, RESISTEC™, which makes the tablet difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection.
Purdue expects to launch Hysingla ER in the United States 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. It is indicated 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.
"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."
I'm very pleased to see another extended-release form of hydrocodone by itself (without acetaminophen). But I'm most happy that there is now an abuse-deterrent formulation. Hopefully this will help doctors feel a little more comfortable about prescribing hydrocodone when it is needed.
What do you think of this new medication? Is Hysingla ER an option you may discuss with your doctor?
“FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties.” FDA News Release, November 20, 2014.
“Purdue Pharma L.P. Receives FDA Approval for Hysingla™ ER (hydrocodone bitartrate) Extended-Release Tablets CII, A Once-Daily Opioid Analgesic Formulated with Abuse-Deterrent Properties.” PR Newswire, November 20, 2014.