The newly approved opioid painkiller Hysingla ER has properties that make abusing it more difficult, which the FDA say is an important step in addressing "the public health crisis of prescription abuse in the US."
The new opioid, approved yesterday, is called Hysingla ER (hydrocodone bitartrate), which is an extended-release (ER) opioid analgesic designed to treat pain severe enough to require around-the-clock, long-term treatment.
According to the Centers for Disease Control and Prevention (CDC), every day in the US, 114 people die from a drug overdose. Meanwhile, another 6,748 are treated in emergency rooms for the abuse or misuse of drugs.
For this reason, the Food and Drug Administration (FDA) deemed it important to protect the public from this growing threat.
"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, adding:
"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."
Tablet difficult to crush, break or dissolve
The FDA say Hysingla ER has approved labeling that describes the product's abuse-deterrent properties, and these are consistent with their 2013 draft guidance for industry.
The properties that make the opioid more difficult to abuse are that the tablet is difficult to crush, break or dissolve. Additionally, it forms a thick gel, making it difficult to be prepared for injection.
- About 9 out of 10 poisoning deaths are caused by drugs
- In 2012, of the 41,052 drug overdose deaths, 53% were related to pharmaceuticals
- Prescription opioid abuse costs were $55.7 billion in 2007.
Though the FDA say the drug's physical and chemical properties make abuse more difficult, they cannot totally prevent abuse of the drug. If an individual takes too much Hysingla ER - intentionally or accidentally - it could result in an overdose or even death.
The newly approved opioid is a strong painkiller and is therefore not for "as-needed" pain relief. The organization notes that because there are still risks for abuse, Hysingla ER should only be prescribed to patients who find alternative treatment options ineffective.
It comes in hydrocodone strengths of 20, 30, 40, 60, 80, 100 and 120 mg, which are 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.
FDA call for post-market studies to assess risks for abuse
What is more, Hysingla ER does not carry the liver toxicity risks associated with hydrocodone combination drugs that contain acetaminophen. Still, the FDA urge caution to health care professionals when prescribing any opioid painkillers.
In a clinical trial involving 905 people with chronic low back pain, researchers assessed the safety and effectiveness of the newly approved drug. Furthermore, say the FDA, additional study data showcased the abuse-deterrent features of Hysingla ER for abuse by oral, snorting and injection routes.
Now, the FDA say they are 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 community.
In September of this year, Medical News Today reported on a study published in Neurology that suggested regulations over opioid prescriptions are "too permissive." Researchers from that study said the adverse effects of opioid painkillers outweigh any benefits for patients with chronic, non-cancer conditions, including headache, fibromyalgia and low back pain.