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FDA approves Purdue’s new anti-abuse hydrocodone
The Food and Drug Administration (FDA) has approved a new anti-abuse hydrocodone extended-release painkiller from Purdue Pharma called Hysingla ER (ER is for Extended Release) made with “abuse-deterrent” technology that discourages chewing, crushing, snorting or injecting.
The new hydrocodone painkiller also contains no acetaminophen, which is found in almost all other hydrocodone painkillers such as Vicodin, Norco and Lortab and many others, as well as over-the-counter painkillers like Tylenol. Acetaminophen is the leading cause of liver damage in America, which can lead to acute liver failure and death.
Hydrocodone-and-acetaminophen painkillers like Vicodin are not only the most prescribed painkillers in the country, contributing to countless cases of liver toxicity, but they’re also among the most widely abused drugs in the country. The need for abuse-resistant hydrocodone tablets without acetaminophen has been evident for years.
Hysingla ER is intended as a once-a-day treatment for patients with “severe, round-the-clock pain that cannot be managed with other treatments.” According to Purdue’s announcement, Hysingla ER is the third drug they have made using the company’s RESISTEC™ “proprietary extended-release solid oral dosage formulation platform.” The company says it’s the “first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting and injection. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible,” the statement continued.
Studies of the effectiveness of its abuse resistance will continue after the drug’s release in the United States in early 2015. Purdue said it expects to launch Hysingla ER in dosages of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg to be taken once every 24 hours.
After more than a decade of highly publicized abuse, addictions, overdose deaths and lawsuits, the company’s controversial extended-release oxycodone painkiller, OxyContin, was reformulated in 2010 using a similar abuse-deterrent system. Purdue claims that evidence shows the change in formulation has led to significantly less abuse.
Meanwhile, the FDA has had to face a firestorm of protests and criticism from both the medical community and the public since it approved Zohydro ER more than a year ago. More than 40 consumer protection, addiction specialist and citizen health care groups across the country have been urging that the FDA reverse its approval of the drug.
Zohydro ER, from drug-maker Zogenix, is also an all-hydrocodone extended-release painkiller like Purdue’s new Hysingla ER. But Zohydro ER has no built-in abuse-resistance at all, which critics insist makes Zohydro ER a massive risk for overdose injuries and deaths among opioid addicts across the country, just as OxyContin was before it was reformulated with abuse resistance.
In spite of the criticism, and even after its own expert medical safety panel gave the drug a firm thumbs down because of the drug’s obvious potential for abuse, the FDA’s hierarchy found some reason somewhere to approve it.
On the business side of things, Purdue’s Hysingla ER certainly will be a potent and potentially devastating commercial challenge to Zogenix’s much-maligned Zohydro ER. We can’t imagine doctors prescribing Zohydro ER with the safer Hysingla ER on the market. In response, Zogenix recently stated that the company is already hard at work to come up with its own abuse-resistant technology, and that it will reformulate Zohydro as soon as it has it perfected.
Here at Novus, we work with many patients who were addicted or made dependent “accidentally”, for want of a better term, while taking legitimate opioid painkiller prescriptions.
Opioids are prescribed for a wide range of ailments, from post-surgical pain to arthritis and even migraines.
But prescription opioid deaths have quadrupled since 1990 to nearly 17,000 a year, and the whole field of pain management is under a lot of pressure to re-evaluate its practices. While some experts argue that opioids should only be used for the most severe cases, such as cancer pain or end-of-life care, others maintain that less severe, short term pain management still requires opioids.
While the FDA continues to receive public pressure to take more effective action, the national epidemic of prescription opioid abuse continues. And here at Novus we continue to deal with it using the most innovative and effective medical detox available.
If you or anyone you care about is having a problem with prescription opioid painkillers or medications of any kind, don’t hesitate to call Novus. We’re always here to help, and will do our best to answer all your questions about prescription drug detox.
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