December 4, 2015
By Alex Keown, BioSpace.com Breaking News Staff
PHOENIX – After its stock dropped nearly 20 percent, Insys Therapeutics defended its practices from allegations it falsified data in order to sell more of its painkiller, the fentanyl-based Subsys. The Arizona-based company said it is committed to patient safety and has complied with all law, including those related to adverse event reporting.
In a statement the company said it has submitted quarterly reports to the U.S. Food and Drug Administration (FDA) of any “adverse events related to Subsys since INSYS launched this product in March of 2012.”
On Wednesday, the Southern Investigative Reporting Foundation (SIRF) issued a report alleging an Insys unit has been misleading insurers to change documents to state that pain was cancer-related in order to prescribe Subsys. Dubbing the company “Murder Inc.,” SIRF alleged Insys had its own representatives complete insurance forms to change the reasons for prescribing the medication. SIRF maintains Subsys, the spray-on painkiller approved for the treatment of cancer-related pain, is 100 times more powerful than morphine. SIRF said the medication was being used to treat chronic pain that was not cancer related, including joint pain or pain related to military injuries. SIRF also alleged that some prescribers received tens of thousands of dollars in kickbacks to prescribe the medication.
While this increased revenue for the company, SIRF charged the use of the medication also led to the deaths of some patients. “Since the drug launched in January 2012, the FDAs Adverse Events Reporting System lists 203 deaths where medical providers fingered Subsys as the probable candidate for triggering an adverse reaction. Moreover, the pace of purported Subsys-related deaths is accelerating, with FAERS disclosing 52 deaths in the second quarter alone,” SIRF said in its report.
Insys said it is unclear if its medication was the sole cause of the majority of the deaths. However, Insys said at least three of the deaths were related to overdosing on the drug, “one accidental, one intentional and one unknown.”
“… it is not unexpected that a percentage of patients, many of whom are gravely ill with cancer, pass away while on Subsys; this does not establish that these patients’ deaths were caused by their use of Subsys,” the company said in a statement. Additionally, Insys said the FDA has not raised any concerns about the safety of Subsys, nor has the regulatory agency asked the company to make any changes to the drug’s label due to safety concerns.
Insys said it delayed the launch of Subsys until after a Fentanyl risk evaluation study was completed “due to the company’s commitment to ensuring the product would be used and prescribed appropriately.”
Since SIRF released its report, Insys stock has dropped nearly 20 percent from $33.45 per share to a low of $25.41 per share at Thursday’s close of trading.
In October, the FDA granted Fast Track designation for Insys’ Naloxone Sublingual Spray for the treatment of known or suspected opioid intoxication or overdose.
