Purdue Pharma’s Abuse-Resistant Painkiller Could Derail Zohydro

The FDA’s approval of a drug it says “will fill an important niche” in the treatment of chronic pain has caused a huge uproar over fears about its potential for abuse.

Zohydro was given the go-ahead in October 2013 for the treatment of moderate-to-severe chronic pain. Developed by the pharmaceutical company Zogenix, Zohydro is composed of an unmixed, undiluted 50-milligram shot of the opioid analgesic hydrocodone, which is the primary ingredient in the well-known and widely prescribed pain-relieving drug Vicodin. Zohydro is approximately five times more potent than Vicodin, however, and according to FDA Commissioner Dr. Margaret Hamburg, it will fill “an important and unique niche” in the crowded prescription painkiller marketplace. Zohydro was released in March, and all patients who receive a chronic pain diagnosis will now be eligible to obtain a prescription for this powerful narcotic.

But the FDA’s decision to approve the release of Zohydro was highly surprising, since its own advisory panel had voted 11-2 against approval. The medical authorities appointed to this panel cited the highly addictive nature of opioid medications as the rationale for their thumbs-down verdict. In the months that have passed since the Zohydro ruling, the criticism directed at the FDA has only intensified, and the agency has been forced to repeatedly defend a decision that many see as indefensible.

Addiction to pharmaceutical-grade painkillers has reached epidemic proportions, and the U.S. Centers for Disease Control has confirmed that opioids like OxyContin and Vicodin are the primary villains in this unfolding tragedy. Many medical professionals apparently came to view these drugs as panaceas and began prescribing them for all degrees of pain and a vast assortment of conditions, and, as a result, opioid addiction rates exploded. Since Zohydro is just a turbo-charged version of Vicodin, it is likely to be far more addictive than its milder cousin, and many medical experts believe it is the height of folly, if not downright hypocritical, for the government to be putting such a potentially dangerous substance into circulation at a time when the fight against prescription drug abuse has just begun to pick up steam.

In September 2013, the FDA announced it was actually tightening label restrictions on opioid painkillers, recommending that physicians use them only with patients who needed round-the-clock treatment for chronic pain and when there were no other viable treatment options available. This action was unequivocally justified as a strategy to combat addiction, so observers were taken aback when only one month later the FDA chose to approve a drug that threatens to accelerate the opioid addiction problem.

Critics of the FDA’s decision launched a campaign to convince the organization to change its minds, and representatives of more than 40 influential healthcare/addiction treatment organizations signed and submitted a letter to the agency that outlined the dangers of adding Zohydro to the menu of available opioid painkillers. But this ardent plea from the experts was to no avail, and the FDA steadfastly refused to reverse its puzzling course.

The (Evil) Genie in the Pill Bottle

The FDA is often accused of having an overly cozy relationship with big pharma and big agriculture, the industries it has been tasked with regulating, and this decision to legalize a new narcotic painkiller despite the negative judgment of its handpicked medical advisors would seem to represent a triumph of favoritism over sensible public policy. In response to what many see as an outrage, separate bills have now been introduced in the House and Senate that if passed would compel the FDA to remove Zohydro from the marketplace.

Compounding the situation, later in the year the drug giant Purdue Pharma will release another single-ingredient/high-dose hydrocodone painkilling drug, in a tamper-resistant form that may render Zohydro obsolete. This company already sells a tamper-resistant version of OxyContin, which allegedly cannot be crushed or dissolved for chewing or snorting and therefore is not supposed to be as addictive (chewing or snorting opioids delivers a more concentrated dosage to the bloodstream). A less malleable form of mega-jolt hydrocodone would presumably offer the same advantages, and the folks manufacturing Zohydro would likely have to switch to a tamper-resistant form themselves if they expected their drug to survive.

But addiction treatment specialists dispute the notion that making addictive drugs harder to alter makes them less dangerous. They note that virtually every person who has become dependent on opioid painkillers started out swallowing pills and only later resorted to chewing or snorting when their substance abuse problems raged out of control. Nevertheless, many fear the positive PR that tamper-resistant technology has received may help to defuse some of the opposition that this new class of drugs has generated, assuming they do eventually show up on the marketplace in this more “respectable” form.

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