New Hydrocodone Painkiller Could Be Abused, FDA Warns

Federal health investigators warn that a proposed narcotic pain killing drug developed by Zogenix Inc., which would be marketed as Zohydro ER, could easily be abused.  

Zohydro ER is a new hydrocodone based opioid pain reliever (OPR) medication developed for the use of moderate to severe chronic pain.

The Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will meet Friday to review the drug and offer a recommendation to the FDA on whether the drug should be approved for sale. While the FDA is not bound to follow the committee’s recommendation, the agency often does.

According to documents released in advance of the meetings, FDA reviewers considered the results of a randomized controlled clinical trial in 1,000 patients with chronic low back pain, which indicate that Zohydro may potentially be more heavily abused than currently available hydrocodone combination products such as Vicodin and Norco.

Randomized Trial Found High Rates of Abuse

Zohydro is classified as single-entity semisynthetic opioid analgesic. Combination opioid pain killers usually contain another non-opioid medication such as acetaminophen. Because acetaminophen overdose can potentially cause liver damage, drug companies created single-entity narcotic pain killers that do not contain Tylenol or other types of pain killers in combination.

Findings of the study, which followed more than 600 subjects who took Zohydro for more than six or 12 months consecutively, revealed a higher level of abuse, among other side effects. Five subjects died during the study. One death was directly linked to a hydrocodone overdose. Other side effects included nervous system disorders, gastrointestinal disorders, nausea, somnolence, fatigue, headache and dizziness.

Reviewers believe the single-entity Zohydro will be more widely abused than what is normally seen with combination OPR drugs based on the abuse rate of oxycodone, commonly sold as generic drugs like methadone and under brand names such as OxyContin and Palladone.

Zohydro Could Mirror OxyContin Abuse Rates

The rates reviewers are comparing Zohydro to are combination oxycodone, containing Tylenol, which has a rate of 24 emergency department visits per million tablets. Single-entity oxycodone, by comparison, has a much higher 85 emergency visits per million tablets.

Prescription painkiller overdoses have increasingly moved to the forefront of health concern in the U.S. As such, the FDA introduced new safety measures for prescription narcotic pain medications like Zohydro or OxyContin, which will provide educational courses for patients and prescribing doctors.

The program, which is part of a Risk Evaluation and Mitigation Strategy (REMS) which is typically used when a drug is considered too dangerous, will offer patients information on signs of overdose, proper care of the drugs, advice on how to store the drugs safely and emergency contact information.

If approved, Zohydro will become the first FDA approved single-entity hydrocodone narcotic pain killer. The advisory panel will review the safety and efficacy of the drug further and will vote on the drug’s approval Friday.