Zogenix, Inc., the San Diego-based manufacturer of the extended-release hydrocodone drug Zohydro ER, has sued the Governor of Massachusetts in U.S. District Court in Boston to overturn as unconstitutional the state’s recent prohibition against prescribing and dispensing the medication.
Zohydro ER is the only FDA-approved hydrocodone drug indicated for daily, round-the-clock, long-term treatment of chronic pain for which other pain treatments are inadequate. The product, which was approved last year, is also the only available extended-release opioid drug containing hydrocodone alone, not combined with acetaminophen, which has been associated with liver damage.
The Governor of Massachusetts recently issued an “emergency declaration” establishing the ban, without consulting Zogenix, on the ground that a hydrocodone-only drug presents a greater risk of overdose and abuse than a hydrocodone combination drug. The ban would remain in place until “adequate measures are in place to safeguard against the potential for diversion, overdose and misuse.”
Zogenix maintains that such safeguards are already in place — “prominent labeling warnings about abuse, a boxed warning about the known serious risks of addiction, abuse and misuse, and statements urging physicians to assess each patient’s risk before prescribing the drug.” Zogenix also points out that Zohydro ER is the only hydrocodone product on the market subject to (1) a Risk Evaluation and Mitigation Strategy (REMS), a program established by FDA to minimize the risks associated with potentially harmful drugs, and (2) strict Schedule II controls established by the Drug Enforcement Administration to prevent abuse.
In its action seeking preliminary and permanent injunctions setting aside the ban, Zogenix contends that FDA approval of Zohydro ER preempts any attempt by a state to restrict the drug’s availability and use. A hearing on Zogenix’s motion for a preliminary injunction was held on April 14; the Court took the matter under advisement.