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Insys: FDA OKs final product label for anorexia treatment

May 24, 2017

Insys Therapeutics, Inc. (NASDAQ:INSY) (“Insys” or “the Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved the final product label for Syndros™ (dronabinol) oral solution, CII, a liquid formulation of the pharmaceutical cannabinoid, dronabinol.  Syndros is approved for use in treating anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (“AIDS”) and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

“The finalization of the approved product label for Syndros by the FDA marks a milestone for Insys and the last regulatory step required prior to the product’s launch,” said Saeed Motahari, President and Chief Executive Officer of Insys.  “Syndros is the second product entirely developed and commercialized by Insys.  We maintain our commitment to bringing novel therapeutic solutions to patients in need and are excited to launch Syndros in August 2017.”

“We believe Syndros represents a viable alternative for the delivery of dronabinol and will fulfill a significant unmet need for both cancer patients undergoing chemotherapy who fail traditional antiemetics and AIDS patients who experience anorexia associated with weight loss,” said Stephen Sherman, Senior Vice President, Regulatory Affairs of Insys.
There are currently over 15 million patients diagnosed with cancer in the United States.  Affecting 70-80% of patients undergoing chemotherapy, chemotherapy-induced nausea and vomiting (CINV) is one of chemotherapy’s most debilitating side effects and often attributed as a leading cause of premature discontinuation of cancer treatment.  Despite the availability of various antiemetics, CINV remains a significant issue for the cancer patient.

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