FDA defends Zohydro approval in opioid abuse debate

FDA Commissioner Margaret A. Hamburg, MD, defended the agency’s approval of the powerful opioid Zohydro ER (hydrocodone bitartrate) extended-release capsules, explaining that its highest dose is no more potent than the highest strengths of the opioid OxyContin ER (oxycodone) extended-release and extended-release morphine, in an FDA blog posted April 29.

Dr. Hamburg explained that with the drug approval, it is unlikely that opioid prescribing will change significantly or use by patients with pain. Zohydro ER is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

“Addressing the opioid crisis by focusing on a single opioid drug will simply not be effective,” she stated. “Instead we must focus our collective attention and energy on the key drivers of the problem, which include excessive prescribing, illegal activity by a small number of providers, improper disposal of unused medications, and insufficient prescriber and patient education.”

At the end of February 2014, a coalition of more than 40 groups, representing physicians, addiction experts, and law enforcement officials, expressed concern in a letter to Dr. Hamburg that Zohydro would fuel more opioid addictions and overdoses. The FED UP! Coalition asked for the Zohydro approval to be revoked.

“After the release of similar high-dose opioid analgesics, thousands of lives were lost from overdose and hundreds of thousands of medical and non-medical users became addicted,” the coalition wrote. “We implore you to take these painful lessons into account.”

Dr. Hamburg believes FDA’s focus needs to be on combatting the misuse and abuse of all opioids. The labeling of all ER/LA opioids includes required warnings and revisions that “incorporate evolving scientific knowledge of risks and benefits,” she said.

FDA requires that all manufacturers of these painkillers provide prescriber training and conduct post-marketing trials to uncover long-term abuse risks associated with these drugs. FDA will monitor use of all opioids to determine if there are any drug abuse problems.

“At the end of the day, the complex public health challenge of opioid abuse requires a comprehensive and science-based approach….Then, and only then, will we truly solve this problem and protect the public health,” Dr. Hamburg concluded.