Full statement from Insys Therapeutics:
Insys Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve the quality of life of patients. Insys is committed to patient safety and ensuring the proper prescribing and use of its products.
As a preliminary matter, we would like to put context around the use of Subsys based upon available data and information. Transmucosal Immediate Release Fentanyl (“TIRFs”, i.e., the class of fentanyl products which Subsys is included in) comprise a very small percentage of all opioid prescriptions in a given year. More specifically, there were approximately 190 million and 175 million opioid analgesic prescriptions written in 2015 and 2016, respectively. In comparison, there were less than 120,000 in 2015 and less than 80,000 prescriptions in 2016 for TIRF REMS products. This class of TIRF products has been trending downward since its peak of approximately 356,000 in 2007. In addition, TIRF products are regulated by a FDA mandated REMS program that is designed to mitigate the risks of misuse, abuse, addiction and overdose of these products. In order for a physician to prescribe, a pharmacy to dispense and a patient to receive a TIRF product, each of the physician, pharmacy and patient must be enrolled in this TIRF REMS program and be educated on, among other matters, the indicated use for such class of products. It is worth noting that not all opioid products are regulated by a mandatory and stringent REMS program.
Subsys was the sixth entrant into the TIRF market and was commercially launched in March 2012. On a percentage basis, TIRFs were less than a tenth of a percentage point of the total opioid market in 2015 and 2016. There were approximately 54,000 total prescriptions in 2015 and approximately 34,000 total prescriptions in 2016 of Subsys, which comprised less than 0.04% percentage of all opioids in each of these respective years. Accordingly, Insys does not believe it (or its fentanyl product Subsys) has contributed to the national, opioid epidemic in any material way.
Insys strives to play a meaningful role in providing solutions to address the opioid epidemic by leveraging its expertise in drug development and in developing innovative products. These potential product solutions include, buprenorphine sublingual spray (a potentially safer opioid), buprenorphine/naloxone spray (for the treatment of opioid dependence), fentanyl/naloxone sublingual spray (an abuse deterrent TIRF), cannabidiol (a novel non-opioid) for the treatment of opioid dependence, cannabidiol for the treatment of pain and naloxone nasal spray (for the treatment of opioid overdose). Insys has committed significant resources to these efforts including seeking guidance and input from nearly 30 researchers across the country and has ongoing collaborations with leading academic institutions.
Insys also requires its personnel to undergo specific training on company policies and procedure which are designed to comply with applicable laws and regulations. In addition, Insys has a comprehensive compliance program in place with protocols and monitoring that are designed to ensure its sales and marketing practices comply with applicable laws.
The charges against individuals, including our former employees, discussed in your news story relate to previously disclosed investigations and litigation. Insys continues to cooperate with all relevant authorities in its ongoing investigations, including our federal investigation which began in and around December 2013. We are committed to complying with laws and regulations that govern the promotion of our products and all other business practices. We continue to emphasize ethical behavior within our organization and pursue opportunities to illustrate that our company’s mission is to put patients first.