Blockbuster sales of Insys painkiller raise suspicions of off-label marketing

When Insys Therapeutics ($INSY) won approval for its new narcotic painkiller, Subsys, in 2012, few predicted the product would find much of a market, because the FDA limited its use to cancer patients who were already on powerful painkillers. But in 2013, the product raked in $96 million in sales, and the company's stock price quintupled to $25 a share.

Now, an investigation by The New York Times is questioning whether the company's success was fueled by improper off-label marketing. Even though the FDA stipulated that only oncologists and pain specialists should prescribe the drug, data provided to the Times by Symphony Health reveals that half of all Subsys prescriptions are written by other types of physicians, including general practitioners, neurologists and dentists.

Former Insys sales reps, who spoke anonymously to the Times, said the company aggressively marketed Subsys--an under-the-tongue fentanyl spray--to physicians who don't treat cancer. They said they were trained to mention the cancer restriction at the beginning of each pitch, but then move on to a more general discussion of pain. The company reportedly targeted high-volume prescribers of competing products like Teva's ($TEVA) Actiq and Fentora.

Few dispute the attributes of Subsys--namely that its sublingual delivery provides immediate relief to cancer patients who may be out of options for relieving their pain. Still, FDA commissioner Margaret Hamburg acknowledged that off-label prescribing of fentanyl products is troubling, especially in light of the restrictions FDA imposes. For example, Subsys prescribers are supposed to undergo special training, pass tests, and register in a national database. "It is frustrating, and we are in a process of continually assessing how our approaches are unfolding in the real world," Hamburg told the Times.

Hamburg has been under fire over the FDA's painkiller policies ever last December, when the agency approved Zogenix's ($ZGNX) all-hydrocodone painkiller Zohydro. The drug lacks abuse-deterrent features, prompting 28 state attorneys general and multiple consumer advocacy groups to push for a withdrawal of the approval. Hamburg continues to defend Zohydro, as well as the agency's overall efforts to control off-label prescribing and keep powerful narcotics out of the hands of addicts.

Earlier this week, Insys issued a "clarifying statement" on Subsys, saying, in part, that the company has an extensive risk-mitigation program designed to prevent misuse, abuse, and overdoses of the drug. As for its marketing activities, the company said, "Insys remains committed to our compliance program and protocols in place that are designed to ensure our sales and marketing practices comply with applicable laws."

So far the Subsys controversy isn't affecting the drug's popularity. Yesterday Insys announced that Subsys' year-over-year sales soared 319% in the first quarter to $40.7 million.

- here's the New York Times story
- access the Insys statement here