Deaths from drug overdose have risen steadily over the past two decades, emerging as the leading cause of death due to injury in the United States. In 2012, of the more than 22,000 deaths relating to pharmaceutical overdose, 72 percent involved opioid pain relievers. In response to the growing crisis, the U.S. Food and Drug Administration has just granted approval for a new prescription opioid with properties specifically designed to make it difficult to abuse.
The new opioid — called Hysingla ER (hydrocodone bitartrate) — is an extended-release (ER) opioid analgesic designed to treat pain severe enough to require around-the-clock, long-term treatment. Approval for the drug was granted on Thursday.
According to the Centers for Disease Control and Prevention (CDC), an estimated 114 people die from drug overdose every day in the United States, and an additional 6,748 are treated daily in emergency rooms for complications arising from drug abuse or misuse. Annually, opioid overdoses account for up to two-thirds of emergency room visits in U.S. hospitals.
Doctors prescribe opioids for a range of ailments, from post-surgical pain to arthritis and migraines. Medical experts disagree over the appropriate role of opioids in treating pain, with some arguing that they should only be used for the most severe cases — such as cancer pain or end-of-life care — while others rightly point out that responsible use can offer remarkable improvements in quality of life for pain sufferers.
The Food and Drug Administration (FDA) has deemed it a priority to protect the public from the growing threat of prescription drug abuse, while also recognizing that some patients will require ongoing pain management with opioid drugs.
“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 abuse in the US,” says Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain,” adds Dr. Woodcock.
Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids — Evaluation and Labeling.
The FDA cites several different properties of the new drug that are expected to make it more difficult to abuse. The tablet is difficult to crush, break or dissolve — properties designed to stop users from snorting or smoking the drug. Additionally, it forms a thick gel, making it unsuitable for injection.
Though the FDA say the drug’s physical and chemical properties make abuse more difficult, they acknowledge that it is still possible. Like other opioids, Hysingla ER can still be abused when swallowed intact – the most common method for abusing painkillers. And taking too much Hysingla ER — intentionally or accidentally — can cause an overdose that may result in death.
Because there are still risks for abuse, the FDA recommends prescribing Hysingla ER only to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management.
The drug is available in strengths of 20, 30, 40, 60, 80, 100 and 120 mg (of hydrocodone), to be taken every 24 hours. However, doses 80 mg and higher should not be prescribed to individuals who have not previously taken an opioid medication.
Though the drug contains higher quantities of hydrocodone compared with immediate-release hydrocodone combination products, the FDA say the range of tablet strengths is comparable to existing approved opioids. Additionally, as a single-entity opioid, Hysingla ER does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen.
Post-market studies needed to assess risks for abuse
Although Hysingla ER has many promising features, the FDA says health care professionals should be aware of the potential risks and always review and consider all available information as part of their decision-making when prescribing opioid analgesics. Furthermore, the agency also notes that the research on Hysingla ER is still ongoing and cannot be considered conclusive.
The safety and effectiveness of Hysingla ER were evaluated in a clinical trial of 905 people with chronic low back pain. Additional data from studies conducted in laboratories and in people demonstrated the abuse-deterrent features of Hysingla ER for certain types of abuse (oral, snorting and injection).
The most common side effects of Hysingla ER are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache and drowsiness.
Now that Hysingla ER has been approved for use, the FDA is requiring post-marketing studies of the drug to demonstrate the effects that the abuse-deterrent features have on the risk for abuse, as well as the consequences of any abuse in the wider population.
In addition, Hysingla ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids.