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INSYS Therapeutics, Inc.

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FDA Accepts New Drug Application for INSYS Therapeutics’ Naloxone Nasal Spray for the Emergency Treatment of Known or Suspected Opioid Overdose

July 03, 2019 at 06:00 am EDT

INSYS Therapeutics, Inc. announced that its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational, proprietary naloxone nasal spray for the emergency treatment of known or suspected opioid overdose in both adult and pediatric patients has been accepted for filing. INSYS’ naloxone nasal spray is a single unit dose spray device that delivers 8mg naloxone dose. The Centers of Disease Control and Prevention reported 70,237 drug overdose deaths in the United States in 2017 of which 47,600 involved opioids.

Latest news about INSYS Therapeutics, Inc.

INSYS Therapeutics, Inc.'s Equity Buyback announced on November 5, 2015, has expired.	20-03-30	CI
INSYS Therapeutics, Inc. Went Out of Business	20-02-17	CI
Bankruptcy Judge Changed for INSYS Therapeutics, Inc.	20-02-05	CI
Second Motion for Exclusivity Period Extension Approved For INSYS Therapeutics, Inc.	20-01-21	CI
Modified Second Amended Liquidation Plan Approved for INSYS Therapeutics, Inc.	20-01-16	CI
Renaissance Lakewood, LLC completed the acquisition of certain assets of INSYS Therapeutics, Inc. (OTCPK:INSY.Q).	19-12-18	CI
Motion for Asset Sale Approved for INSYS Therapeutics, Inc.	19-12-16	CI
Second Amended Disclosure Statement Approved for INSYS Therapeutics, Inc.	19-12-04	CI
Renaissance Lakewood, LLC entered into an asset purchase agreement to acquire certain assets of INSYS Therapeutics, Inc. (OTCPK:INSY.Q) for $0.28 million.	19-12-02	CI
Second Amended Liquidation Plan And Disclosure Statement Filed by INSYS Therapeutics, Inc.	19-11-29	CI
First Amended Liquidation Plan Filed by INSYS Therapeutics, Inc.	19-11-14	CI
First Motion for Exclusivity Period Extension Approved For INSYS Therapeutics, Inc.	19-11-04	CI
Chilion Group Holdings US, Inc. completed the acquisition of Assets from INSYS Therapeutics, Inc. (OTCPK:INSY.Q) for $12.3 million.	19-10-30	CI
INSYS Therapeutics, Inc. Announces Resignation of Andrew G. Long, Chief Executive Officer, Board of Directors, Effective November 8, 2019	19-10-25	CI
Motion for Asset Sale Approved for INSYS Therapeutics, Inc.	19-10-16	CI
First Motion for Exclusivity Period Extension Filed by INSYS Therapeutics, Inc.	19-10-07	CI
Motion for Case Conversion Filed for INSYS Therapeutics, Inc.	19-09-25	CI
Pharmbio Korea Co., Ltd. agreed to acquire certain assets of Insys Therapeutics, Inc.	19-09-24	CI
Insys Therapeutics : Drugmaker Insys wins bankruptcy court approval to sell off opioid	19-09-19	RE
Motion for Asset Sale Approved for INSYS Therapeutics, Inc.	19-09-19	CI
Joint Liquidation Plan and Disclosure Statement Filed by INSYS Therapeutics, Inc.	19-09-17	CI
BTcP Pharma, LLC entered into an asset purchase agreement to acquire Fentanyl sublingual spray product from INSYS Therapeutics, Inc.	19-09-02	CI
Hikma Pharmaceuticals USA Inc. completed the acquisition of Naloxone And Epinephrine Nasal Sprays from INSYS Therapeutics, Inc. (OTCPK:INSY.Q).	19-08-28	CI
Motion for Asset Sale Approved for INSYS Therapeutics, Inc.	19-08-23	CI
Motion for Asset Sale Approved for INSYS Therapeutics, Inc.	19-08-22	CI

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Company Profile

Insys Therapeutics, Inc. is a commercial-stage specialty pharmaceutical company. The Company develops and commercializes supportive care products. The Company's product Subsys, is a sublingual fentanyl spray for breakthrough cancer pain (BTCP) in opioid-tolerant patients and a single-use product that delivers fentanyl, an opioid analgesic, for transmucosal absorption underneath the tongue. The Company markets Subsys through its field sales force focused on supportive care physicians in the United States. Subsys delivers a liquid fentanyl formulation in approximately 100, 200, 400, 600, 800, 1,200 and 1,600 micrograms (mcg) dosages. The Company's lead dronabinol product candidate is Syndros, which is under review for approval at the Food and Drug Administration. In addition, the Company is evaluating sublingual spray, inhaled and intravenous formulations of dronabinol in preclinical studies.

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