Zogenix said yesterday it is suing the state of Massachusetts to overturn the ban it imposed last week on the company’s Zohydro™ ER (hydrocodone bitartrate) extended-release (ER) capsules. The case will focus on what rights, if any, do states have to limit the marketing of prescription drugs beyond rules set by the FDA.
In a complaint filed in U.S. District Court for Massachusetts, Zogenix requested a temporary restraining order against the executive order signed March 27 by Gov. Deval Patrick (D) which bars prescribing and dispensing of the company's prescription pain product that was approved by the FDA.
Patrick banned Zohydro after declaring a public health emergency, citing the state’s opioid addiction epidemic, and said the ban would last until the state was satisfied that measures existed to “safeguard against the potential for diversion, overdose, and misuse” of the painkiller. He noted that Zogenix didn’t design Zohydro ER with an abuse-deterrent formulation, as FDA required for OxyContin (oxycodone). The potential for abuse was cited by an FDA advisory panel, but it did not sway the agency, which approved the drug for market on October 25.
In January 2013, FDA issued draft guidance requiring abuse-resistant measures for all opioids, but the agency has yet to finalize it or demand all opioids be marketed with them. FDA has also stopped short of demanding abuse resistance in generic versions of oxymorphone product Opana ER (which like OxyContin was also reintroduced with abuse deterrence), as requested by its maker Endo Pharmaceuticals.
Zohydro ER is the first and only extended-release hydrocodone without acetaminophen, unlike the AbbVie painkiller Vicodin or the UCB pain drug Lortab . The opioid agonist is indicated for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment, where alternative treatment options are inadequate, using Alkermes’ Spheroidal Oral Drug Absorption System (SODAS®) drug delivery technology.
Zogenix contends that Gov. Patrick’s executive order is in direct conflict with the FDA’s authority to determine whether a drug is safe and effective, and to impose measures ensuring that the drug will be used safely and appropriately.
“In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data,” Zogenix CEO Roger Hawley said in a statement. “Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order."
In the statement, Zogenix alleges that Patrick never answered a formal written request for a meeting to discuss Zohydro.
The Massachusetts ban may be followed by a national ban. Last week, U.S. Sen. Joe Manchin (D-W. Va.), and U.S. Reps. Stephen Lynch (D-Mass.) and Hal Rogers (D-Ky.) introduced separate bills to ban Zohydro ER and any future formulations that lack abuse-deterrent mechanisms. The FDA has been considering such a ban, which is also being sought by attorneys general from 29 U.S. states.
Zogenix instead supports an effort underway by the U.S. Drug Enforcement Agency (DEA) to reclassify Zohydro and other hydrocodone combination products like Vicodin from DEA Schedule III to Schedule II, the stricter standard now covering oxycodone products. Zogenix says the stricter classification would better reduce the potential for abusing the drug.
The company and FDA agreed on final safety labeling and post-marketing requirements consistent with new rules adopted in September for all ER and long-acting opioid painkillers.