FDA approves new hydrocodone drug

The U.S. Food and Drug Administration has approved a hydrocodone drug known as Hysingla ER that has properties expected to reduce, but not totally prevent, abuse of the drug (the tablet is difficult to crush, break or dissolve and cannot be easily prepared for injection.)

Dentists should be aware that their patients might ask about the drug, which is not approved for, and should not be used for, as-needed pain relief. Taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in death. According to the FDA, Hysingla ER 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.

Paul Moore, DMD, PhD, professor of pharmacology, dental anesthesiology and dental public health at the University of Pittsburgh School of Dental Medicine, was quoted as follows in the ADA News.

"Hysingla ER is a delayed release single-entity formulation that contains only hydrocodone. It is indicated specifically for severe, poorly controlled chronic pain and will have few indications in dental medicine and in the management of acute postoperative pain," said Moore, who also is a member of the ADA Council on Scientific Affairs. "However, as these formulations become available, it will be important for dentist to know if a patient is taking an opioid such as Hysingla because of possible drug interactions with prescribing analgesics and sedatives."

According to the FDA, strengths of Hysingla ER contain 20, 30, 40, 60, 80, 100 and 120 milligrams (mg) of hydrocodone to be taken every 24 hours. Doses of 80 mg per day and higher should not be prescribed to people who have not previously taken an opioid medication (opioid non-tolerant). While Hysingla ER contains larger amounts of hydrocodone compared to immediate-release hydrocodone combination products, the range of tablet strengths of Hysingla ER is comparable to existing approved ER opioids.

For more information, visit fda.gov.