Few drugs in recent memory have caused an uproar like the new prescription painkiller Zohydro has. The company behind it, San Diego-based Zogenix (ZGNX), says it constitutes an advance in pain treatment. Critics warn that it could feed the country’s epidemic of painkiller abuse and overdose.
The stir hasn’t disrupted Zogenix’s marketing effort, said Ann Rhoads, chief financial officer, during a presentation on Tuesday at the JMP Securities Healthcare Conference in New York. “People have commented to us that old adage: that there’s no such thing as bad publicity,” she said. Insurance companies “know a lot more about the product when we have our initial meetings.”
The Food and Drug Administration approved Zohydro in December after its scientific advisory committee voted 11-2 against allowing the drug on the market. Twenty-nine state attorneys general urged the FDA to reconsider and warned of “the potential to exacerbate our nation’s prescription drug abuse epidemic.” Massachusetts Governor Deval Patrick tried to ban the drug in March; a federal judge halted his order. Delaware ordered prescribing restrictions last week.
Zogenix plans to target about 20,000 prescribers it describes as “high decile [extended-release/long-acting] opioid prescribers” who account for 60 percent of the market. Zohydro ER (for extended-release) is a long-acting form of hydrocodone; unlike others on the market, such as Vicodin (ABBV), it contains no acetaminophen, which can cause liver damage. The company sees a place for Zohydro right next to the multibillion-dollar market for OxyContin and additional opioids, according to its investor presentation (PDF):
Another OxyContin is precisely what some in public health and law enforcement fear. Chicago and two counties in California are currently suing the manufacturers of OxyContin and other painkillers, alleging that misleading marketing downplayed addiction risks and created unwitting addicts. They’re responding to opioid overdose deaths, which have more than tripled over 10 years:
Those suits argue that the drugs shouldn’t be used for chronic pain such as back pain or arthritis, despite the FDA’s approval. Criticism of painkillers once focused on the risk that they could fall into the wrong hands—children or people abusing them without a prescription. “These new cases are really making a much more important point, which is that these medicines are harmful when taken exactly as prescribed,” says Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing and a frequent critic of opioid makers.
Rhoads said the company wants to go “over and above” the FDA’s requirements to monitor how the drug is used, with an advisory board of addiction specialists and law enforcement reviewing prescribing data. It’s also providing patients with pill bottles that have combination locks. Two forms of Zohydro intended to be more resistant to abuse by snorting, chewing, or injecting are in the works for 2016.
Zohydro hit the market in March; Zogenix reported that about 9,000 prescriptions were filled through June 13. Right now, insurance companies are deciding how they’ll cover the drug, Rhoads said. Their decision, more than anything, may determine whether Zohydro finds a place in America’s medicine cabinet.