The launching of Zohydro, a new sustained-release oral narcotic by Zogenix, has triggered outcries of criticism from health care providers and concerned citizens, while some claim such fears may not be justified. The new drug received approval from the FDA in October 2o13, overriding the recommendation of an advisory committee of paid experts who voted, 11-2, against its release.
Zyhydro contains hydrocodone bitatrate, in extended-release form, as its active ingredient. The pill breaks new ground in two ways. This medication is the first to offer hydrocodone as a pure agent and, also, the first to introduce a sustained-release version of the narcotic. Hydrocodone, trade-named Vicodin and Lortab have, hitherto, come in 5 mg, 7.5 mg, and 10 mg tablet strengths combined with 500 mg of acetaminophen (Tylenol). These tablets last from four to six hours. Zohydro, on the other hand, does not contain acetaminophen and comes in dosage units ranging from 10 mg to 50 mg that last for 12 hours.
Critics warn of the abuse potential inherent in such a formulation. Indeed, according to the Center for Disease Control (CDC), drug overdose death rates more than tripled since 1990, and nearly 75 percent of these deaths occurred from prescription painkillers. Since 1999, the sales of strong painkillers also tripled. In 2010, over 12 million people admitted to taking prescription painkillers for non-medical, or recreational, use. Concern also exists over the fact that Zohydro can be easily crushed and injected intravenously by street users. The crushing of the drug subverts the extended timing mechanism, making the full unit dose available for immediate release, thus increasing the potential for a deadly overdose. Street users generally avoid combo drugs like Vicodin because acetaminophen causes horrendous liver damage, fatal in large doses. This makes Zohydro an attractive candidate for “crush and shoot” abuse.
Dr. Andrew Kolodny, one of the more forthright critics, stated that Zohydro “will kill people as soon as it’s released” and called the event “shocking, outrageous, and genuinely frightening.” A coalition of over 40 healthcare addiction treatment groups wrote to the FDA urging the revocation of this “new, dangerous, high-dose opioid.” But how justified are fears of the new narcotic?
Paul Gileno, president and founder of the U.S. Pain Foundation, and an advocate for those suffering with chronic pain, does not see abuse as an issue for patients. “A person with pain is a person suffering to get pain relief in order to live a fulfilling life.”
Interestingly, sustained-release oral tablets containing pure opioids have been around for awhile, including MS Contin, with the active ingredient, morphine; and Oxycontin with oxycodone. Exalgo contains hydromorphone, or Dilaudid, perhaps the most potent narcotic, in extended-release form. Charts depicting the potency of opioid drugs use morphine as the benchmark. While oxycodone exceeds the potency, by one-and-a-half to two times, and Dilaudid stands as five times more potent, hydrocodone is little more than half as potent as morphine. Oxycontin comes in doses ranging from 10 mg to 160 mg. Exalgo offers 32 mg as its maximum dose. This means that the highest forms of Oxycontin and Exalgo exceed, by several times, the potency of the 50 mg maximum dose of Zohydro.
So just how justified are the fears of Zohydro? As as new drug, perhaps not justified at all as it does not really embody a “new” pharmaceutical design. However, it may be argued that this drug is more easily crushed than Oxycontin, whose manufacturer, Purdue Pharma, L.P., has made the tablet difficult to crush into a powder. Also, the fact that the launching of Zohydro simply means increased narcotic market availability may, in itself, be reason for concern.
By Robert Wisnewski