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Subsys fentanyl spray manufacturer under investigation for alleged off-label marketing

The drugmaker Insys Therapeutics is under investigation for violation of federal laws relating to the off-label promotion of the fentanyl spray Subsys and other pharmaceutical products. Officials contend that Insys may have aggressively promoted Subsys to physicians for off-label use despite the fact that such marketing is prohibited under federal law.

These suspicions have been borne out by a recent study which analyzed the doctors who are prescribing Subsys to their patients. Despite the fact that fentanyl products such as Subsys are intended only for opioid tolerant patients such as cancer sufferers, a study by the industry analysis group Symphony Health found that only 1% of prescriptions for the fentanyl spray were written by oncologists. The study also found that half of Subsys prescriptions were written by pain specialists, while the remainder were written by doctors with minimal experience or training with severe pain management, including general practice practitioners, neurologists, dentists, and even podiatrists.

Because fentanyl is extremely potent—about 80-100 times stronger than morphine—prescribing products like fentanyl to patients who are not suffering from chronic, severe pain places them at higher risk of a potentially deadly overdose. More than 35,000 Americans are killed each year as a result of opioid overdose, many of these due to the use of the fentanyl pain patch or other fentanyl products.

The investigation of Insys for the company’s promotion of the Subsys fentanyl spray is not the first time that federal officials have taken action against the maker of oral fentanyl products in recent years. In 2008, Cephalon was forced to pay $425 million in criminal penalties for its off-label promotion of Actiq, the fentanyl lollipop. The FDA later denied Cephalon approval for its fentanyl tablets, Fentora, after learning that the product was already being widely prescribed to non-cancer patients.

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