FDA Approves Controversial Painkiller Hysingla

In a move drawing concerns from addiction treatment experts, the FDA approved a powerful long-acting opioid pankiller last week without seeking input from advisory committee experts. The new drug, Hysingla™ ER, contains pure hydrocodone, a narcotic, in an extended-release formulation without the acetaminophen used in other opioids. Hysingla would be taken once every 24 hours by patients requiring constant pain relief and will contain as much as 120 milligrams (mg) of hydrocodone. The FDA has set a warning limit for opioids with doses of 80 mgs or more, noting that such products “should not be prescribed to patients who have not previously taken an opioid medication.

Hysingla’s drug manufacturer Purdue Pharma announced that the new drug will be packaged in an “abuse-deterrent” tablet. Officials at both the FDA and Purdue noted that although the drug will not be abuse-proof, the abuse-deterrent formulation is a step forward in reducing abuse and misuse. 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 that cannot be easily prepared for injection.

According to the FDA, the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult, but not impossible. The agency stated that it was important to note that taking too much Hysingla ER, whether by intentional abuse or by accident, could result in an overdose that may result in death. The FDA noted that Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the agency’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

Under the FDA’s determination, Hysingla ER is not approved for as-needed pain relief. The FDA noted that the opioid should only be prescribed to individuals for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management. The FDA is requiring postmarketing studies of Hysingla ER to assess the effects of the abuse-deterrent features on the risk for abuse of Hysingla ER and the consequences of that abuse in the community. In addition, Hysingla ER is part of the Extended Release/Long-Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy, 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.

Hysingla ER, similar to the controversial Zohydro™ ER, is composed of a dose of pure hydrocodone, the main ingredient in the painkiller Vicodin. Earlier this year in March, Massachussetts Governor Deval Patrick tried to ban Zohydro ER, which was approved by the FDA against the recommendation of its own advisory committee. Massachussetts declared a public health emergency, saying the drug could deepen the state’s prescription abuse epidemic. A judge ruled, however, that the state could not overrule the judgment of the FDA, and effectively revoked the ban.