I distinctly remember feeling surprised when the FDA approved the first single entity and extended-release hydrocodone pain medication.
Extended-release hydrocodone bitartrate (Zohydro ER) was originally approved by the FDA in October 2013 for the treatment of severe pain requiring daily, around-the-clock, long-term treatment for which alternative therapy options were inadequate.1
I distinctly remember feeling surprised when this unique product, the first single entity and extended-release hydrocodone pain medication, was approved, especially since an FDA advisory panel had voted against it. This medication could potentially be fatal, and it has no abuse-deterrent properties.
According to the US Centers for Disease Control and Prevention, approximately 15,000 individuals die annually from prescription drug overdoses involving opioid analgesics.2 Controversy surrounded the approval of Zohydro ER, even to the point of requesting that it be removed from the market.
In January 2015, the FDA approved a new formulation that will include BeadTek, which contains abuse-deterrent properties that will be available in products during the second quarter of 2015.3 With this technology, a viscous gel is formed when individuals try to crush or dissolve the product.
The manufacturer, Zogenix, is performing follow-up studies involving the new abuse-deterrent technology.3 For legitimate pain patients, this medication may serve as a beneficial treatment option. On the other hand, pharmacists must be vigilant of the abuse potential and have the appropriate safeguards in place, as Zohydro ER is a Schedule II controlled substance.
Pharmacists can identify doctor shoppers through the use of a prescription drug monitoring program in states that have established it. Patients should also be counseled on the potential for abuse, and expired or unused medications should be disposed of through local drug take-back programs to prevent potential exposure to family members. Additionally, Zohydro ER should be kept locked away and out of reach of children and family members.
As pharmacists, we must balance the benefits and risks of this medication.