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FDA Approves Abuse-Deterrent Hydrocodone Pill

Tablet is difficult to crush, break, or dissolve for illicit use

The FDA has given the green light to Hysingla ER (hydrocodone bitartrate, Purdue Pharma), an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult, but not impossible.

Taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in 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. “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.”

Hysingla ER is not approved for, and should not be used for, as-needed pain relief. Given the risks for abuse, misuse, and addiction with Hysingla ER, the drug should be prescribed only to people for whom alternative treatment options are ineffective, are not tolerated, or would be otherwise inadequate to provide sufficient pain management. As a single-entity opioid, Hysingla ER does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen. The FDA encourages health care professionals to review and consider all available information as part of their decision-making when prescribing opioid analgesics.

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

The safety and effectiveness of Hysingla ER were evaluated in a clinical study of 905 patients with chronic low back pain. Additional data from studies conducted in laboratories and in human subjects demonstrated the abuse-deterrent features of Hysingla ER for certain types of abuse (i.e., oral, snorting, and injection). The most common adverse effects of Hysingla ER were constipation, nausea, fatigue, upper respiratory-tract infection, dizziness, headache, and somnolence.

The FDA is requiring post-marketing studies of Hysingla ER to assess the effects of its abuse-deterrent features on the risk of abuse of the drug and the consequences of that abuse in the community.

Source: FDA; November 20, 2014.

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