Drug Company Seeking Approval for Tamper-Resistant Version of Zohydro

Zogenix, the company that released the controversial pure hydrocodone drug, Zohydro ER, earlier this year has submitted an application to the Food and Drug Administration (FDA) seeking approval for a more tamper-resistant version of the drug.

In October 2013, the FDA approved Zohydro for patients who suffer from chronic pain and who require daily, long-term treatment. Although the approval was granted against the recommendation of a panel appointed by the FDA, it was ultimately decided that the need for the drug outweighed the risk of abuse and addiction.

Chronic pain patients choose Zohydro because it was the first pain medication that consists of pure hydrocodone. Other pain meds like Vicodin contain a combination of hydrocodone and acetaminophen, which can cause irreversible liver damage in large quantities. It is for these same reasons that many opposed the approval of the drug because of its high level of potency, lack of tamper-resistant features and potential for abuse.

Zogenix claims that the new version contains a thick gel in the capsule that deters a potential abuser from injecting or snorting the substance. This new tamper-resistant design seems to be an improvement from previous crush-resistant technology applied to OxyContin, although some addiction specialists point out that a person could still abuse the drug by swallowing the contents of the capsule.

“The new technology being added to Zohydro ER represents a meaningful advancement because it incorporates properties designed to deter abuse yet maintain the efficacy of the medication, a central consideration throughout the product’s development,” said Stephen Farr, Ph.D., president of Zogenix.

The introduction of any tamper-resistant features applied to Zohydro will indeed be an improvement since the drug currently has no such characteristics and can be easily crushed and snorted by people seeking a strong, immediate high.