PHOENIX, Aug. 22, 2017 (GLOBE NEWSWIRE) -- Insys Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the Company”) today released the following statement:
Like so many stakeholders in the healthcare community and in the government, we share the desire to address the serious national challenge related to the misuse and abuse of opioids that has led to addiction and unnecessary deaths and has caused so much pain to families and communities around the country.
Our recent settlement with the State of Illinois, which includes an obligation to make a $4.45 million payment, reflects our firm commitment to take responsibility for actions by our former employees and we affirm our continued intent to put patients first as reflected by our actions and ethical behavior.
With that in mind, we do not believe it is factually accurate to state that Insys has materially contributed to the opioid crisis in the State of Illinois or the nation. As the healthcare community and the government seek solutions to our national opioid crisis, it can be disheartening when this dialogue on this extremely important topic disregards the enormous amount of data and other facts available to all stakeholders. We set forth below some of the relevant facts for consideration regarding our product and the Transmucosal Immediate Release Fentanyl (“TIRF”) class:
- By many estimates, this crisis began more than a decade and a half ago. SUBSYS® has been available since March 2012.
- In 2016, SUBSYS® accounted for approximately 34,000 prescriptions nationally and less than 1,000 prescriptions in the State of Illinois. In other words, in 2016, SUBSYS® was less than 0.02% of all opioid prescriptions nationally and less than 0.01% of all opioid prescriptions in the State of Illinois.
- These 2016 prescription numbers for SUBSYS® do not place Insys within the top 50 manufacturers of opioids in the United States.
- A doctor is not permitted to prescribe, a pharmacy is not permitted to dispense, and a patient is not permitted to receive any TIRF product, including SUBSYS®, unless each of them is enrolled in the Food and Drug Administration (“FDA”) mandatory TIRF Risk Evaluation and Mitigation Strategy (“REMS”) program. The TIRF-REMS program strives to limit the risk of abuse and misuse by restricting prescriptions to appropriate patients, preventing inappropriate conversions between medicines and educating patients, pharmacists and prescribers about potential for abuse, addiction and overdose of TIRFs, as well as the label for these products.
- In the National Heroin Threat Assessment Summary issued in June 2016, the Drug Enforcement Administration concluded that “pharmaceutical fentanyl is diverted for abuse in the United States at small levels” and recent overdose deaths from fentanyl are “largely due to clandestinely-produced fentanyl, not diverted pharmaceutical fentanyl.” https://www.dea.gov/divisions/hq/2016/hq062716_attach.pdf
It is our hope that Insys can focus on solution-based initiatives regarding the opioid crisis such as developing alternative pain medications, increasing physician and patient education on appropriate use of scheduled products and coordinating on monitoring systems where there is ample evidence that these initiatives will reduce the incidence of abuse, addiction and overdose. We are committed to playing a productive role in solutions as is reflected in our investment and efforts in research and development and educational programs.
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. Using proprietary sublingual spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intending to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS currently markets SUBSYS® (fentanyl sublingual spray) and SYNDROS™ (dronabinol oral solution), a proprietary, orally administered liquid formulation of dronabinol. INSYS is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy, and other disease areas with a significant unmet need.
SUBSYS® and SYNDROS™ are trademarks of Insys Development Company, Inc., a subsidiary of Insys Therapeutics, Inc.
NOTE: All trademarks and registered trademarks are the property of their respective owners.
This press release contains forward-looking statements including regarding our (i) belief that it is not factually accurate to state that Insys has materially contributed to the opioid crisis in the State of Illinois or the nation and (ii) hope that Insys can focus on solution-based initiatives regarding the opioid crisis. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release; actual results may differ materially from those in these forward-looking statements as a result of various factors, many of which are beyond our control. These factors include, but are not limited to risk factors described in our filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent updates that may occur in our Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date of this press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.
Lisa M. Wilson
Insys Therapeutics, Inc.