Purdue Pharma L.P. Wins FDA Approval For Powerful Painkiller Hysingla
Published: Nov 24, 2014
November 21, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Purdue Pharma L.P. announced on Nov. 20 that the U.S. Food and Drug Administration has approved of Hysingla, a medication that can be used for patients who are experiencing chronic pain. More importantly, the drug does not contain acetaminophen, which has been linked to liver failure when it’s overused.
"The burden of chronic pain and the abuse of prescription medications are both pressing societal problems," said Charles Argoff, 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."
This is the first hydrocodone product to be recognized by the FDA that deters abuse through chewing, snorting and injection. Hysingla, also known as hydrocodone bitartrate, is an extended release tablet that is taken once per day. It was created using Purdue’s proprietary extended release solid oral platform, Resistec.
"We are proud to offer healthcare professionals and chronic pain patients another treatment option," said Mark Timney, CEO of Purdue Pharma L.P. "Hysingla ER is the third product in our pain management portfolio to receive an FDA label describing its abuse-deterrent characteristics. These innovations are an important step forward in helping meet patients' needs while also working to deter misuse and abuse."
Purdue will launch Hysingla ER in the U.S. in early 2015, and it will have dosage strengths between 20mg and 120mg, set to be taken every 24 hours. Hysingla will have Tier 1 labeling, which means that it is formulated with physico-chemical barriers to abuse. Additionally, it will include Tier 3 labeling, which indicated that the product is expected to result in a reduction in abuse.
That being said, Hysingla still includes hydrocodone, which is a Schedule II controlled substance. This means that it exposes users to the risk of opioid addiction, misuse and abuse. Addiction can occur at any point if the recommended doses of the drug are misused or abused.