The U.S. Food and Drug Administration has approved a new extended release version of hydrocodone – an opioid pain reliever that will be the first and only hydrocodone product to be marketed with an abuse deterrent formula.
The potent painkiller – which will be sold by Purdue Pharma under the brand name Hysingla ER – gives stiff competition to Zohydro, a controversial hydrocodone medication that was introduced earlier this year without abuse-deterrent properties. Hysingla is designed to be taken once a day, while Zohydro is meant to be taken twice a day to relieve chronic pain.
Hysingla’s formulation makes it more difficult for drug abusers to crush or liquefy for snorting or injecting. The FDA noted, however, that abuse of Hysingla is “still possible” and taking too much of it can lead to overdose and death.
“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Hydrocodone combination drugs such as Vicodin are the most commonly prescribed and abused painkillers in the country with over 130 million prescriptions annually.
Last month, the Drug Enforcement Administration reclassified all hydrocodone products as Schedule II medications to make them more difficult to get. As a result, many pain patients with legitimate prescriptions for hydrocodone say pharmacists are refusing to fill their prescriptions or claiming the drug is out of stock.
Unlike Vicodin and other hydrocodone combinations, Hysingla and Zohydro are “pure” hydrocodone medications that do not contain acetaminophen or other pain relievers that can have side effects such as liver toxicity.
“Hysingla ER is not approved for, and should not be used for, as-needed pain relief. Given Hysingla ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management,” the FDA said in a statement.
“Hysingla ER does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen.”
Purdue expects to launch Hysingla ER in early 2015 in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg.
The safety and effectiveness of Hysingla ER were evaluated in a clinical trial of 905 people with chronic low back pain. Additional studies were conducted to demonstrate its abuse-deterrent features. The most common side effects of Hysingla ER are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache and drowsiness. The FDA is also requiring postmarketing studies of Hysingla ER to assess its risks for abuse.
“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.”
Zogenix, the San Diego-based maker of Zohydro, is working on its own abuse deterrent formula for Zohydro. Teva Pharmaceuticals is also developing on a similar hydrocodone product.