Dive Brief:
- Embattled opioid drugmaker Insys Therapeutics Inc. will pay $4.45 million in a settlement with the state of Illinois over charges the company deceptively marketed its fentanyl-based painkiller Subsys outside of its approved indication for treatment of cancer pain.
- Illinois Attorney General Lisa Madigan filed a lawsuit in 2016 which accused Insys for promoting Subsys to doctors who generally prescribed opioids for pain, rather than oncologists treating cancer patients.
- Money from the settlement will be used to fund programs tackling the growing problem of opioid abuse in communities throughout Illinois. Insys will also be required to set up an opioid abuse detection program and to restrict promotion of Subsys only to oncologists or prescribers who affirm they treat cancer pain.
Dive Insight:
There has been an uptick of opioid lawsuits across the U.S. in recent years — a response to the country's growing opioid epidemic. Insys has already been ensnared in several before the most recent agreement with Illinois.
In 2015, Insys settled agreement with the Oregon Department of Justice for $1.1 million without admitting any violation of law or regulation. A year later, the company settled with the state of New Hampshire for $2.9 million and made a $500,000 contribution to a New Hampshire charitable foundation for preventing problems related to the abuse or misprescribing of opioid drugs.
An investigation by the state of Massachusetts is still pending and U.S. attorneys in 11 states have requested information, including subpoenas, about Insys' interactions with healthcare professionals in those states.
More recently — late last year — six former executives of Insys were arrested and charged for bribing doctors to prescribe Subsys (fentanyl sublingual spray) and for defrauding health insurers who were reticent to pay for the drug outside of its approved patient population.
Insys has only two marketed products. Subsys, which is described by Insys as the "first and only sublingual spray for breakthrough cancer pain," has been on the market in the U.S. since March 2012. Insys' second product, Syndros (dronabinol oral solution) was launched in July 2017 for anorexia associated with AIDS, as well as nausea and vomiting associated with chemotherapy treatment.
Sales of Subsys fell to $42.6 million in the second quarter of 2017, down from $69.2 million during the same period a year prior. Insys attributed the decline to falling Subsy prescription volumes due to "softness in overall demand" in the drug's category.