INSYS Therapeutics, Inc. (INSY) Announces Participation at FDA Advisory Committee Meeting

INSYS Therapeutics, Inc. (INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today announced that Dr. Dean Mariano, senior director, clinical development and medical affairs at INSYS, presented during the first day of the U.S. Food and Drug Administration’s (FDA) Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee meeting being held Dec. 17 and 18, 2018.

In his presentation, Dr. Mariano discussed the importance of co-prescribing naloxone to chronic use opioid patients; a position supported by data from a recent study conducted in which co-prescriptions resulted in fewer overdoses and fewer hospitalizations. Dr. Mariano’s remarks noted that co-prescribing naloxone may have a positive impact on unintentional opioid overdose deaths. However, it is difficult to predict who on chronic opioid therapy will experience an overdose. Therefore, if naloxone is co-prescribed in a Universal Precautions manner for all patients receiving chronic opioid therapy, it may have a significant impact on unintentional opioid overdose deaths.

“Given the ongoing opioid crisis in the United States, the FDA Advisory Committee meeting on the necessity of co-prescribing naloxone and opioids is an important step in understanding how to curb accidental overdoses in chronic use patients,” said Dr. Ahmed Elkashef, vice president of clinical development at INSYS Therapeutics. “We were privileged to participate in this critical discussion and look forward to providing additional insights on how to best serve and protect these patients in the future.”

An archive containing meeting materials, including slides, a transcript, and webcast replay of the meeting, which was held at the FDA White Oak Campus in Silver Spring, Maryland, can be found on the FDA website.

About INSYS
INSYS Therapeutics is a specialty pharmaceutical company that develops and commercializes innovative drugs and novel drug delivery systems of therapeutic molecules that improve patients’ quality of life. Using proprietary spray technology and capabilities to develop pharmaceutical cannabinoids, INSYS is developing a pipeline of products intended to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS is committed to developing medications for potentially treating anaphylaxis, epilepsy, Prader-Willi syndrome, opioid addiction and overdose, and other disease areas with a significant unmet need.

Forward-Looking Statements 
This news release contains forward-looking statements based on management’s expectations and assumptions as of the date of this news 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 Dec. 31, 2017 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 news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.