What is the FDA Approved New Painkiller, Zohydro?

Although the FDA’s advisory committee voted against the controversial drug by a vote of 12 to 2, the FDA chose to override their recommendation. Critics, including attorneys general from 28 states, are petitioning FDA commissioner Margret Hamburg, MD to prevent Zohydro from becoming available to the public. “It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.“

Opioid analgesics have long been used to relieve chronic pain. These drugs are designed to help manage pain severe enough to require long-term opioid treatment. The drugs work by subduing the pain transmissions to the central nervous system. Zogenix is not free to advertise Zohydro for uses other than chronic pain relief, but doctors are free to prescribe opioid analgesics to patients they deem in need of them. As narcotics, however, the drugs can have serious side effects if not used as intended.

The Perfect Prescription for Abuse and Overdose

Critics want the FDA to reverse approval of the new painkiller Zohydro because the drug is a simple one to abuse. Currently, Zohydro is the only FDA-approved extended-release product that contains the opioid hydrocodone. Zohydro will be available in doses that exceed 45 milligrams, or five times the amount of hydrocodone in immediate-release pills. Although the drug is designed to be released slowly into the body over the course of 12 hours, crushing the pill will allow the dose to be released all at once, leading to the possibility of overdose. Jason Jerry, MD, an addiction specialist at Cleveland Clinic, is disturbed that Zogenix is so eager to release Zohydro for public consumption before a safer version of the drug has been developed. “I’m not sure why there is this great rush to get this to the market,” he said in a statement. Members of the FDA’s controlled substance staff also protested against the release of Zohydro. “If approved and marketed, Zohydro will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” said medical officer Lori Love, MD, Ph.D., and pharmacologist James Tolliver, Ph.D.

Another argument presented against Zohydro is the fact that there are many other pain relief drugs available on the market. Additionally, very little research has been done on whether opioids relieve pain unrelated to cancer beyond the three-month mark. Physical therapy and cognitive-behavioral therapy have proven to be valid approaches to relieve chronic pain unrelated to cancer. Doctors also suggest alternatives such as taking Tylenol (acetaminophen) and Advil (ibuprofen). For very unpleasant days, a Vicodin could be ingested.

Formulation for Minimizing Abuse

Zogenix’s response to the negative publicity surrounding Zohydro is polite but firm. “[We are] currently evaluating two different technologies to ensure we develop the most effective formulation to minimize misuse and abuse,” says spokeswoman Julie Normart.