Last week Zohydro was shipped to pharmacies and since then the maker of the drug, Zogenix, has experienced a backlash. The Food and Drug Administration approved the formula, the first pure form of hydrocodone, in December. Since then, it has been often criticized and caused concern for not being resistant to abuse and has potential to worsen the epidemic of prescription abuse. However, the concern may not last long with Zohydro potentially being replaced by an abuse free version of hydrocodone.
The makers of OxyContin, Purdue Pharma, have completed testing for their newest project and announced a new hydrocodone that is resistant to recreational abuse. Gary L. Stiles, the company’s senior vice president of research and development, stated that this was one more step towards offering chronic pain patients a therapeutic option that would be “unattractive to drug seekers.”
This news of a abuse-resistant painkiller follows the recent release of Zohydro, which is the primary ingredient of Vicodin. A number of medical groups, law makers, and state prosecutors have expressed fear that the drug will worsen the nation’s prescription drug abuse, which has already become a severe epidemic. Zohydro is a strong and effective pain treatment, but the possibility of opiate dependency has made it controversial.
The extended-release formula of hydrocodone is planned to be submitted to the FDA within this year. Purdue Pharma has designed the new tablets to prevent the pill from being crushed by users who would be snorting or injecting it. With this new information Zohydro’s maker, Zogenix, saw their shares experience a drop of over 20 percent. It is unlikely that physicians would prescribe a tablet that is susceptible to abuse if a different hydrocodone option was available. If the FDA concludes the new Hydrocodone is a safer option to offer patients, Zohydro will potentially be taken from the market and replaced by the abuse free painkiller.
The concern behind Zohydro is well founded. The epidemic of drug related death has caused the DEA to make adjustments that statistics suggest will help. Early March, the Drug Enforcement Administration published its proposal to classify hydrocodone combination products (HCPs) to Schedule II, where hydrocodone itself has been listed since 1970. Schedule II is reserved for harmful drugs that have a high risk of abuse with potential to lead to severe dependence. HCPs are opioid painkillers, the same chemical class as morphine and heroin. However, they contain acetaminophen, which is aspirin, and have been classified Schedule III. The FDA and Assistant Secretary for Health and Human Services recently recommended this movement to allow further control over the drugs.
Overdose has been increasing rapidly as a cause of death since 2000, and prescriptions for painkillers are a main contributor, killing around 15,000 Americans each year, the Centers for Disease Control and Prevention reported. That number includes only those prescribed the drugs by physicians and does not cover the millions of users who also take them.
Monitoring the Future surveys, referenced by the DEA, released the results of studying 8th, 10th, and 12th graders from 2002 through 2011. According to their findings, OxyContin, a more securely controlled painkiller of Schedule II, is used half as much by 12th graders. This means the more easily accessed Vicodin on Schedule III is abused non-medically twice as much. The statistics could add reassurance that the better control of more dangerous substances should cut down the risk. Zohydro will be working towards a replacement formula, like the new Hydrocodone, which offers hope that both could add abuse free options for patients with chronic pain.
By: Whitney Hudson