INSYS Files New Drug Application (NDA) For Buprenorphine Sublingual Spray With FDA

Published: Sep 29, 2017

- Advances R&D for promising portfolio of innovative medicines

PHOENIX, Sept. 29, 2017 (GLOBE NEWSWIRE) -- In advancing its pipeline of innovative medicines, INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”), announced today that it filed a New Drug Application (NDA) for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain with the U.S. Food and Drug Administration (FDA).

“We believe that buprenorphine sublingual spray represents a promising new treatment option that will address an unmet need for physicians and patients who would like an alternative to the traditional opioids used to treat their moderate-to-severe acute pain,” said Steve Sherman, senior vice president of Regulatory Affairs at INSYS. “As a partial mu-opioid agonist, it is believed that buprenorphine has less abuse potential than other opioids frequently used in this indication and is thought to have a ceiling effect for respiratory depression.”

According to published research, buprenorphine’s other potential advantages as a treatment for acute pain include less cognitive impairment and less constipation compared to full opioid agonists. This research suggests that buprenorphine possesses unique pharmacological properties that may make it a safe and efficacious alternative to traditional opioids, especially outside of a hospital setting.

“Our NDA for buprenorphine sublingual spray marks another major milestone for the company’s R&D pipeline,” said Saeed Motahari, president and chief executive officer of INSYS. “This submission to the FDA supports our goal of filing one NDA every year for the next five years as we execute on our collective vision and expand our product portfolio.”

In addition to buprenorphine sublingual spray, INSYS is also developing treatments for a variety of conditions other than pain, including synthetic cannabidiol (CBD) for two types of pediatric epilepsy and Prader-Willi syndrome; dronabinol oral solution for anorexia associated weight loss in cancer patients; buprenorphine/naloxone sublingual spray for opioid dependence; naloxone nasal spray for opioid overdose; epinephrine nasal spray for anaphylaxis reaction; and rizatriptan nasal spray for migraine.

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 intending to address unmet medical needs and the clinical shortcomings of existing commercial products. INSYS currently markets SUBSYS® (fentanyl sublingual spray), CII, and SYNDROS® (dronabinol) oral solution, CII, 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.

Forward-Looking Statements
This news release contains forward-looking statements including regarding our belief that (i) buprenorphine sublingual spray represents a promising new treatment option that will address an unmet need for physicians and patients who would like an alternative to the traditional opioids used to treat their moderate-to-severe acute pain, and (ii) buprenorphine has less abuse potential than other opioids frequently used in this indication and is thought to have a ceiling effect for respiratory depression. These forward-looking statements are 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, 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 news release, and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

CONTACT:

Media Relations
Joe McGrath
Senior Director, Corporate Communications
INSYS Therapeutics
480-500-3101
jmcgrath@insysrx.com

Investor Relations
Jackie Marcus or Chris Hodges
Alpha IR Group
312-445-2870
INSY@alpha-ir.com

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