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|Insys Therapeutics Announces FDA Approval of Syndros™|
"We are very pleased to announce
“Syndros is the first and only
Approximately 9,500 prescribers account for 70% of current dronabinol prescriptions. Insys expects to convert a large portion of the market to Syndros as well as expand the market through direct detailing to physicians, highlighting the improved product profile of Syndros. The Company anticipates launching Syndros in the second half of 2016.
SyndrosTM is approved for anorexia associated with weight loss in patients with AIDS.
SyndrosTM is approved for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
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 SyndrosTM 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 SyndrosTM 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 worsen while on treatment.
To learn more about SyndrosTM, and its Important Safety Information, please contact
Subsys® and SyndrosTM are trademarks of
This press release contains forward-looking statements regarding: (i) our belief that Syndros will be an important new treatment option for certain patients, (ii) our belief that certain benefits of Syndros will be important differentiators for patients and prescribers, (iii) our belief that these benefits will be key drivers of a successful market launch and sustained growth and our expectations that that Syndros’ attractive and differentiated profile will enable rapid market conversion as well as increase Syndros usage; and (iv) our anticipated timing of the commercial launch of Syndros. 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