|Results Show Favorable Effect of Company’s Novel Formulation, Similar to Intramuscular Administration; NDA Filing with FDA on Track for 2018
PHOENIX, Oct. 03, 2017 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ:INSY) (“INSYS” or “the company”), announced today that its recently completed pharmacokinetics (PK) study of the company’s proprietary intranasal naloxone spray formulation for the treatment of opioid overdose showed favorable results, similar to those for the current standard of intramuscular administration of naloxone.
“We believe that an intranasal naloxone spray formulation represents a potentially valuable alternative to treat known or suspected opioid intoxication or overdose,” said Steve Sherman, senior vice president of Regulatory Affairs at INSYS. “Based on the results of this study, we look forward to working with the FDA to bring this promising treatment alternative to the people on the front lines of the opioid crisis.”
Naloxone has been used in opioid overdose management for more than 40 years. It works by rapidly displacing the intoxicating opioids from the brain’s opioid receptors, reversing the clinical signs of opioid overdose if administered soon enough. Naloxone was first approved in the United States in 1971 as Narcan® injection to reverse opioid intoxication and overdose. It is currently available in injectable, intranasal and auto-injector delivery forms.
“We are excited by the data from this study, and we look forward to working with the FDA on the regulatory path ahead,” said Saeed Motahari, president and chief executive officer of INSYS. “While our R&D focus has shifted to pharmaceutical cannabinoids, a significant part of continuing efforts in investing and developing our naloxone program relate to the social responsibility associated with this type of product. Pending a successful NDA filing in 2018 and subsequent FDA approval, our intention is to launch our intranasal naloxone spray at an affordable price.”
This investigational product is the first from INSYS to use an intranasal spray technology. Other pipeline product candidates from the company that use this technology include epinephrine nasal spray for anaphylaxis reaction and rizatriptan nasal spray for migraine.
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.
This news release contains forward-looking statements including regarding (i) our belief that an intranasal naloxone spray formulation represents a potentially valuable alternative to treat known or suspected opioid intoxication or overdose and (ii) our intention is to launch our intranasal naloxone spray at an affordable price. 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.
Senior Director, Corporate Communications
Jackie Marcus or Chris Hodges
Alpha IR Group
Insys Therapeutics, Inc.