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.1 Zohydro is also one of the only opioid pain relievers to contain only hydrocodone and no acetaminophen, which can cause liver damage.
What Makes Zohydro Unique
Because Zohydro is an extended-release based drug, it has more of the medicine in each capsule to ensure its longer-lasting effects. Although initially released as a 50mg capsule, there are now dosing options of 10, 15, 30, 40 and 50 mg.2 This does not mean that it is more potent than other opioids, however. New technology is also being developed for a new form of the drug that will help prevent crushing to circumvent the extended-release functionality.
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 in order to protect the country from any unsafe drugs that are to be approved and sold.3
Zohydro as an Opioid
Opioid medications—used to treat debilitating or chronic pain—all have the potential for abuse and addiction. Zohydro is no different. Like other opioids, it causes the brain to feel pleasure when it is in your system. These good feelings are usually what hook patients, as it is hard to resist the pleasant feelings. They are known for patients quickly developing tolerance and dependence.4
Stopping taking Zohydro can cause withdrawal symptoms, making it harder for users to stop taking the drug even if they know it has become a problem. Common opioid withdrawal symptoms include the following:
- Trouble sleeping
- Trouble breathing
- Physical dependence
In 2016, there were over 214 million prescriptions for opioids, including Zohydro, in the US.6 Although it is helpful to have new medications to treat pain, like Zohydro, it also increases the prevalence of pills available to abuse and end up being sold to fuel addictions.
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 non-medical purposes, we can help.
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. Please call our 24 hour, toll-free helpline now for more information.
1 “FDA Provides Facts About Zohydro.” US Food and Drug Administration, March 14, 2016.
2 “Pernix Announces Availability of Zohydro ER 20 mg Dosage Strength.” Clinical Pain Advisor, March 18, 2018.
3 “How Drugs Are Developed and Approved.” US Food and Drug Administration, August 18, 2015.
4 “What are prescription opioids?” National Institute on Drug Abuse, January 2018.
5 “Opiate and opioid withdrawal.” Medline Plus, April 5, 2018.
6 “US Prescribing Rate Maps.” US Centers for Disease Control and Prevention, July 31, 2017.