Controversy swirls around the approval of Zohydro, a new narcotic pain reliever manufactured by Zogenix, Inc. Zohydro ER is an opioid containing hydrocodone in capsule form that is intended as an extended-release formula. This means that one pill should last 12 hours, so those suffering from chronic pain don’t have to take as many pills throughout the day. Zohydro is also one of the only opioid pain relievers to contain only hydrocodone and no acetaminophen, which can cause liver damage. Zohydro isn’t the first opioid created to treat chronic pain, so why all the fuss?
Reasons for Concern
For one thing, Zohydro packs a bigger punch than its counterparts, containing 50 milligrams of hydrocodone in one capsule as compared to 10 milligrams in one Vicodin pill. This is in part due to the fact that Zohydro is meant to be an extended-release formula as opposed to Vicodin’s instant release.
Another element of this drug that has emergency rooms and physicians on standby is its lack of tamper-resistance. The fear is that people looking for a high will crush the pills and either snort or inject all 50 milligrams at once, sending the entire dose into the bloodstream simultaneously which can lead to overdose and death.
Other drugs with high doses of opioids meant for extended release like OxyContin have safeguards in place. These pills turn into a jelly-like substance when crushed, making them nearly impossible to use recreationally. It was years before the makers of OxyContin created this tamperproof pill however, and in that time, millions of addicts were created and overdose deaths skyrocketed. Many believe that creating a new hydrocodone medication without these safeguards is inviting another epidemic.
The FDA’s advisory committee voted 11-2 against approving Zohydro citing its high potential for abuse and asking for safeguards to be put in place before marketing. The drug was approved anyway in part due to its simplicity, lack of liver-damaging acetaminophen, and “on the grounds that it is safe and effective for pain when used as directed.” This, of course, is the crux of the issue. Abusers and addicts are not likely to use the medication as directed.
Across America, attorneys general from 29 states have called for the FDA’s reconsideration of Zohydro’s approval. Deval Patrick, the Governor of Massachusetts, declared a public health emergency because of the lack of abuse-deterrence features and fatal overdose potential and went so far as to ban Zohydro from being dispensed or even prescribed in the state. The manufacturer of Zohydro, Zogenix, took the issue to federal court and won. The ban was struck down; even though the judge recognized the abuse potential of the drug, he also cited the federal authority of the FDA over state law and decided pain sufferers could not be denied access to this type of relief.
Other states are also getting involved and trying to get ahead of the potential backlash of Zohydro abuse. Governor Peter Shumlin of Vermont put emergency rules in place, demanding that physicians follow certain practices like drug-testing and follow-up appointments or risk having their licenses revoked. In addition, patients are required to provide informed consent. Members of Congress have also asked the FDA to review their decision, and many families whose lives have been torn apart by opioid addiction have submitted petitions on various forums.
The FDA seems to be sending mixed signals, while approving the drug on one hand and attempting to shift hydrocodone-containing drugs from Schedule III controlled substances to the more stringent Schedule II on the other hand. Schedule II drugs have more rules in place for prescriptions and dispensing, and this change is still awaiting approval from the Drug Enforcement Agency. The approval for Zohydro came one day after the proposal of the hydrocodone schedule change. Spokespeople for the FDA claim the two are not connected.
Drug Approval Process
So how do new drugs get approved? Here is a rough outline for the approval process:
- Drug need is exposed
- Discovery and development of drug
- Research and development, synthesis of substance, pre-clinical trials including animal testing, review
- Investigational new drug (IND) application is submitted to the FDA’s Center for Drug Evaluation and Research (CDER)
- Three phases of clinical trials, starting with testing of healthy subjects and moving on to testing those who would need the drug
- New drug application (NDA) is submitted to the FDA
- FDA experts review the NDA, the company is given opportunity to respond to concerns, and an advisory hearing may be called
- FDA approval of marketing and proposed labeling
The FDA does not actually test the drugs itself – that is the responsibility of the company submitting the drug for approval – although they do employ experts to review the data submitted. The FDA also reserves the right to put a “clinical hold” on the process at any point. “The mission of the FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective.”
The FDA also has the power to overlook or overturn the findings of their review board as was the case with Zohydro.
Dangers of Opioids
Opioid medications are derived from the opium poppy plant and meant to treat people with consistent and reoccurring pain. These narcotics are prescribed when the traditional and less potent forms of pain medication are no longer enough. Those suffering from back pain or cancer pain who need constant pain management typically present a case for this type of medication. Other known opioids include morphine, codeine, and even opium and heroin.
Opioids work by attaching to opioid receptors in the brain, dulling pain, stimulating the reward system in the brain, and increasing the production of the neurotransmitter dopamine which gives the user a euphoric feeling.
These good feelings are usually what hook patients, as it is hard to resist the pleasant feelings. The problem with these medications is that if you take them constantly, they alter brain chemistry and you can build up a tolerance to the drug. Users need more and more of the drug for it to continue to be effective.
Opioids suppress the part of the brain responsible for respiration and breathing, so increasing dosage increases the chances a user will just stop breathing, creating a fatal overdose. Withdrawal symptoms are also harsh, making it harder for users to stop once they have started developing a dependency. Some of the other risk factors include:
- Trouble sleeping
- Trouble breathing
- Physical dependence
Every day in the United States, 100 people die from a drug overdose, and a large percentage of deaths are due to prescription drug overdoses, particularly prescription painkillers.
Prescription painkiller abuse and overdose deaths continue to rise, with over 12 million people reporting using prescription painkillers for nonmedical purposes in 2010.
Although Zohydro is a relatively new drug on the market, medical professionals are no stranger to the effects of hydrocodone and its addiction potential. Whether the dependence started out as an attempt to find relief from chronic pain or from abusing prescription medications for nonmedical purposes, we can help.
Finding the right treatment center is important to recovery. At The Oaks at La Paloma, we offer a state-of-the-art detoxification program with the assistance of physicians; this is important as withdrawal symptoms from opioids can be harsh. If you are, or someone you know is, addicted to an opioid, you should seek help as stopping the drug cold turkey can be dangerous. Users need to be weaned off the drug in a safe setting.
Call for a Confidential Assessment
A low client-to-staff ratio ensures that the individual needs of each person are treated with care. Specialized treatment plans are devised by skilled professionals and suited to fit the unique needs of each individual. Call now for more information.
 Olsen, Y.; Sharfstein, J. (May 2014). “Chronic Pain, Addiction, and Zohydro.” New England Journal of Medicine. Accessed July 10, 2014.
 Smith, S. (Feb. 2014). “New Pain Pill’s Approval; ‘Genuinely Frightening.'” CNN. Accessed July 10, 2014.
 “How Drugs are Developed and Approved.” (Feb. 2014). FDA. Accessed July 10, 2014.
 Grush, L. (April 2014). “Zohydro: Why This Painkiller Could Spark Another Addiction Epidemic.” Fox News. Accessed July 10, 2014.
 “Policy Impact: Prescription Painkiller Overdoses.” (July 2013). Center for Disease Control and Prevention. Accessed July 10, 2014.