Relief from Breakthrough Pain in Adults with Cancer in as Little as 5 Minutes: Is it Worth the Risk?

Subsys, the first and only fentanyl sublingual spray fentanyl sublingual spray (under the tongue) is a prescription medication used to manage breakthrough (or sudden increase in pain) pain in adults with cancer who are opioid tolerant or who are already already using and are tolerant to round-the-clock narcotic pain medicines.

Manufactured by Insys Therapeutics, Inc., Subsys claims to effectively control breakthrough cancer pain and provide relief in as little as 5 minutes. However, because it is a strong opioid (narcotic) pain medicine which can be misused and abused by people, it is, therefore considered as a federally controlled substance (CII).

Due to this risk of misuse, overdose, abuse and addiction, Subsys can be acquired only through the Risk Evaluation and Mitigation Strategy (REMS), a restricted program by the Food and Drug Administration. Healthcare professionals who prescribe Subsys to outpatients, as well as outpatients themselves, distributors and pharmacies, must first enroll in the Transmucosal Immediate-Release Fentanyl (TIRF) REMS Access program to gain access to Subsys.

Fentanyl, which is the main ingredient of Subsys and which belongs to a class of drugs known as opiate or narcotic analgesics, works in the brain and changes how the body feels and responds to pain. Misuse of SUBSYS, like misuse of any narcotic pain medication, can cause overdose, addiction, or death; this is why patient must take this medication only in accordance to doctor’s instruction. This medicine should never be shared with others also and, most especially, should not be used on children, as the amount of fentanyl in each spray can be fatal to a child.

Subsys has been linked to many side-effects. Despite these side-effects, Subsys spray lawsuit is centered on the illegal way that Insys Therapeutics, Inc. has promoted Subsys to doctors, which is in violation of FDA rules. This is by marketing Subsys as treatment for neck pain, migraines and for off-label use, that is for conditions that have not been approved by the FDA. Under the law, while it is allowed for doctors to prescribe drugs for off-label use, this same privilege is the given to pharmaceutical companies.