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Letters to the Editor

Clarification on Hydrocodone (Zohydro)

Stephen J. Farr PhD, MRPharmS

To the Editor:

I am reaching out on behalf of Zogenix and wanted to provide additional information and clarification in response to the recent P&T editorial (July 2012, page 399), titled “Hydrocodone Rescheduling Amendment and Pipeline Products on the Horizon” and its characterization of Zohydro, as the statement as published is incorrect.

While the piece correctly discusses the fact that Zogenix submitted a New Drug Application (NDA) to the FDA in May 2012 for Zohydro™ (hydrocodone bitartrate extended-release capsules), the piece also makes a mistaken reference to the amount of hydrocodone found in Zohydro as compared to Vicodin, and we felt it was important to clarify this point.

Zohydro uses the active ingredient hydrocodone, which is the same active ingredient found in hydrocodone combination products such as hydrocodone/acetaminophen (Vicodin) or hydrocodone/ibuprofen. Zohydro is an extended-release formulation, which means the medicine is released over a longer period of time, 12 hours, versus the immediate-release products that are currently available. Those products are dosed more frequently at 4 to 6 hours. Zohydro will be available in a variety of dosage strengths that will allow physicians to customize dosages to the individual needs of patients with chronic pain.

In addition, we wanted to add that Zogenix submitted a comprehensive Risk Evaluation and Mitigation Strategy (REMS) program in the Zohydro NDA with the intent of reducing inappropriate prescribing and the misuse of the product while maintaining access to patients suffering from chronic moderate to severe pain. If approved, Zohydro will also be regulated as a DEA Schedule II product, which will have stricter prescribing and refill limits than Schedule III products.

Sincerely,Stephen J. Farr, PhD, MRPharmSMember of the Royal Pharmaceutical SocietyPresident and Chief Operating OfficerZogenix, Inc.San Diego, Calif.