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The Food and Drug Administration (FDA) has approved Hysingla ER (hydrocodone bitartrate; Purdue) extended-release tablets for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Hysingla ER is designed with abuse-deterrent properties that are expected to reduce, but not completely prevent, abuse of the drug when chewed and ingested orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel which cannot be easily prepared for injection. These properties should make abuse by these routes difficult, however, taking too much of the drug, either intentionally or by accident, could lead to overdose and death.
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The approval was based on data from a clinical trial of patients with chronic low back pain (n=905). Other conducted studies showed the abuse-deterrent properties of Hysingla ER for abuse through oral, snorting, and injection routes. Postmarketing studies are being required to further examine the effects of the abuse-deterrent properties on risk of abuse and the consequences of that abuse. Hysingla ER is included in the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS).
Hysingla ER will be available in 20mg, 30mg, 40mg, 60mg, 80mg, and 120mg extended-release tablets. The product will begin shipping on January 5, 2015.
For more information visit FDA.gov.
