Zogenix To Implement Voluntary Safeguards For Zohydro

Amid the debate centered on the approval of Zogenix’s painkiller drug Zohydro, the company said it is implementing several voluntary safeguards against possible misuse of the drug. Zogenix also referenced the support Zohydro received from both the U.S. Food and Drug Administration (FDA) and Health Human Services (HHS) in order to reaffirm the drug’s quality.

Zohydro ER is an opioid agonist developed by Zogenix as an extended-release, oral formulation of hydrocodone bitartrate. Zohydro is indicated for management of pain reaching severe levels as to require daily, round-the-clock, and long term opioid treatment for which no adequate alternative treatment options exist.

The approval of Zohydro drew criticism from opponents who called for restricted access to the drug. The latest effort to limit access to the drug included a state ban from Massachusetts Governor Deval Patrick.

FDA Commissioner Margaret Hamburg issued a statement rebuking state and federal efforts to restrict access to the drug. Zogenix affirmed the FDA’s move, saying, “We agree with Commissioner Hamburg's call for preserving access to pain medicines for the patients who need them the most. We believe that allowing politicians who have incomplete and false information to force a reversal of the FDA's considered decision to approve Zohydro ER – or any other medication – after that agency's painstaking review, would set a very dangerous precedent.’

The company will also employ several voluntary and novel safeguards against potential diversion, overdose, and misuse of their drug. These include:

• Establishment of an External Safe Use Board of experts to monitor and review prescriptions and report any patterns of abuse to the FDA and other federal authorities
• Bringing to the forefront the critical role of education by compensating our product representatives not on sales volume of Zohydro ER, but rather on their efforts to ensure prescribers, pharmacists and patients are educated to understand the risks and benefits of using extended-release opioids
• Providing patients who are prescribed Zohydro ER access to free locking pill bottle caps and discounted safe-storage units to prevent others in the home from obtaining easy access to medicine that was not prescribed for them

Zogenix said it is the first and currently only opioid pharmaceutical company which has taken such steps to ensure their product is not intentionally misused. The safeguards will be effective from the first day of Zohydro’s availability.