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Insys Announces FDA Final Product Label Approval

May 24, 2017

 

PHOENIX, May 24, 2017 (GLOBE NEWSWIRE) -- 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. 

 

About Chemotherapy Induced Nausea and Vomiting (CINV)


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. 

 

About Anorexia in AIDS


Since the early 1980s, there have been 1.2 million patients diagnosed in the US with AIDS. 


Despite the advancements for the treatment of AIDS, 7-8% of AIDS patients currently experience anorexia associated with weight loss. ₁

 

SYNDROS™ Important Safety Information

 

SYNDROS™ may cause psychiatric and cognitive effects and impair mental and/or physical abilities. Patients with cardiac disorders may experience hypotension, hypertension, syncope, or tachycardia. Discontinue products containing disulfiram or metronidazole at least 14 days before and do not administer 7 days after treatment with SYNDROS™ (see Full Prescribing Information). 

 

Weigh the potential risk versus benefits before prescribing SYNDROS™ to patients with a history of seizures, including those requiring anti-epileptic medication or with other factors that lower the seizure threshold. Assess risk for abuse or misuse inpatients with a history of substance abuse or dependence, prior to prescribing SYNDROS™ and monitor for the development of associated behaviors or conditions. Consider dose reduction or discontinuation, if worsening of symptoms of paradoxical nausea, vomiting, or abdominal pain occurs while on treatment.

 

To learn more about SYNDROS™, and its Important Safety Information, please contact Insys Therapeutics, Inc. at 1-855-978-2797.

 

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 the quality of life of patients. Using proprietary sublingual 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 one product, SUBSYS® (fentanyl sublingual spray), CII, and has received approval for the marketing of SYNDROS™ (dronabinol) oral solution, CII, a proprietary, orally administered liquid formulation of dronabinol that INSYS believes has distinct advantages over the current formulation of dronabinol in soft gel capsule. 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.

 

Forward-Looking Statements 

 

This press release contains forward-looking statements including regarding our (i) belief that the finalization of the approved product label of SYNDROS™ is a milestone for the Company, (ii) belief that 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, and (iii)  belief that that SYNDROS™ has distinct advantages over the current formulation of dronabinol in soft gel capsule. These forward-looking statements are based on management's expectations and assumptions as of the date of this press 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 December 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 press release and we undertake no obligation to publicly update or revise these statements, except as may be required by law.

 

NOTE: All trademarks and registered trademarks are the property of their respective owners.

 

  1. Prevalence of Cachexia (Wasting Syndrome) Diagnosis and Treatment Among Patients with HIV/AIDS: A Medical Claims Database Analysis: Boulanger L1, Miller JD1, MacEachern L2, Reddy P1, Russell MW1, Pashos CL1 1Abt Associates, Inc., Lexington, MA, USA; 2Par Pharmaceutical, Inc., Woodcliff Lake, NJ, USA

 

 

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