Click here for important risk information.

PATIENT INFORMATION
SYNDROS (sin dros)
(dronabinol)
oral solution, CII

What is SYNDROS?

  • SYNDROS is a prescription medicine used in adults to treat:
    • loss of appetite (anorexia) in people with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.
    • nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.

SYNDROS is a controlled substance (CII) because it contains dronabinol which can be a target for people who abuse prescription medicines or street drugs. Keep your SYNDROS in a safe place to protect it from theft. Never give your SYNDROS to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.

It is not known if SYNDROS is safe and effective in children.

Do not take SYNDROS if you:

  • had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.
  • had an allergic reaction to alcohol.
  • are using a medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) or have taken or received a medicine that contains disulfiram or metronidazole in the last 14 days.

Before taking SYNDROS, tell your doctor about all of your medical conditions, including if you:

  • have or had heart problems.
  • have or had problems with drug abuse or dependence.
  • have or had problems with alcohol abuse or dependence.
  • have or had mental health problems including mania, depression or schizophrenia.
  • have had a seizure or have a medical condition that may increase your risk of having a seizure.
  • are pregnant or plan to become pregnant. SYNDROS may harm your unborn baby. Avoid the use of SYNDROS if you are pregnant.
  • are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their breast milk to the baby. It is not known if SYNDROS passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SYNDROS. Do not breastfeed while taking SYNDROS and for 9 days after your last dose of SYNDROS if you are being treated for nausea and vomiting caused by anti-cancer medicine.

Tell your doctor about all the medicines you take or have taken in the last 14 days, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SYNDROS and certain other medicines can affect each other, causing serious side effects.

How should I take SYNDROS?

  • See the "Instructions for Use" at the end of the Patient Information for detailed instructions about the right way to take SYNDROS.
  • Always use the oral syringe that comes with your SYNDROS oral solution to measure your prescribed dose. Ask your doctor or pharmacist to show you how to measure your prescribed dose.
  • Take SYNDROS exactly as your doctor tells you to. Your doctor may change your dose after seeing how it affects you. Do not change your dose unless your doctor tells you to change it.
  • Drink a full glass of water (6 to 8 ounces) right after you take your prescribed dose of SYNDROS oral solution.
  • If you are an adult with AIDS with loss of appetite and weight loss:
    • SYNDROS is usually taken 2 times each day, 1 hour before lunch and 1 hour before dinner. If you are elderly, or unable to tolerate this dose of SYNDROS, your doctor may prescribe SYNDROS to be taken 1 time each day, 1 hour before dinner or bedtime.
  • If you are an adult with nausea and vomiting caused by anti-cancer medicine:
    • SYNDROS is usually taken 1 to 3 hours before your chemotherapy treatment and then every 2 to 4 hours after chemotherapy for up to 4 to 6 doses each day. If you are elderly, your doctor may prescribe SYNDROS to be taken 1 to 3 hours before your chemotherapy, 1 time each day.
    • Take your first dose of SYNDROS on an empty stomach at least 30 minutes before eating. After your first dose of SYNDROS, you can take SYNDROS with or without food.
    • After your doctor has decided the dose of SYNDROS that is right for you, take SYNDROS exactly at the same time before or after meals during future chemotherapy treatment.
  • If you take too much SYNDROS, call your Poison Control Center at 1-800-222-1222 right away or go to the nearest emergency room.

What should I avoid while taking SYNDROS?

  • Do not drive, operate machinery, or do other dangerous activities until you know how SYNDROS affects you. SYNDROS taken with medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.

What is the most important information I should know about SYNDROS?

SYNDROS can cause serious side effects, including:

  • Worsening mental (psychiatric) symptoms. Psychiatric symptoms can worsen in people who have mania, depression, or schizophrenia and who take SYNDROS. SYNDROS taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take SYNDROS may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.
  • Problems thinking clearly. Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.
  • Changes in your blood pressure. SYNDROS may increase or decrease your blood pressure, especially when you start taking SYNDROS or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.
  • Interactions with disulfiram or metronidazole. SYNDROS contains alcohol, which can cause you to have a reaction to medicines that contain disulfiram or metronidazole. You should not use any medicine that contains disulfiram (Antabuse) or metronidazole (Pylera, Flagyl, Flagyl ER, Nuvessa, Vandazole) if you take SYNDROS. You should not use a medicine that contains disulfiram or metronidazole for at least 14 days before you start taking SYNDROS and within 7 days after your last dose of SYNDROS. Tell your doctor if you have signs or symptoms of a reaction to disulfiram or metronidazole including: stomach-area (abdominal) cramping, nausea, vomiting, headache, and flushing.

What are the possible side effects of SYNDROS?

SYNDROS may cause serious side effects, including:

  • See "What is the most important information I should know about SYNDROS?"
  • Seizures. SYNDROS may increase your risk of seizures. Stop taking SYNDROS and call your doctor and get medical care right away if you have a seizure during treatment with SYNDROS.
  • Drug and alcohol abuse. You may have an increased risk of abusing SYNDROS if you have a history of drug or alcohol abuse or dependence, including marijuana. Tell your doctor if you develop abuse behaviors such as increased irritability, nervousness, restlessness or want more or higher doses of SYNDROS during your treatment.
  • Nausea, vomiting, or stomach-area (abdominal) pain. Tell your doctor if you have nausea, vomiting, or abdominal pain or if your nausea, vomiting, or abdominal pain gets worse during treatment with SYNDROS.

The most common side effects of SYNDROS include:

  • stomach-area (abdominal) pain
  • dizziness
  • feeling extremely happy (euphoria)
  • nausea
  • overly suspicious or feeling people want to harm you (paranoid reaction)
  • sleepiness
  • abnormal thoughts
  • vomiting

These are not all the possible side effects of SYNDROS. Tell your doctor if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of SYNDROS

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SYNDROS for a condition for which it was not prescribed. Do not give SYNDROS to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about SYNDROS that is written for health professionals.

What are the ingredients in SYNDROS?

Active ingredient: dronabinol
Inactive ingredients: dehydrated alcohol, polyethylene glycol 400, propylene glycol, sucralose, methyl paraben, propyl paraben, butylated hydroxyanisole, and water

Click Here for Full Prescribing Information

Press Release

Insys Therapeutics, Inc. Announces FDA Final Product Label for Syndros

Launch Planned for August 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

Investor Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
212-452-2793

Insys Therapeutics Announces FDA Approval of Syndros™

PHOENIX, AZ – July 05, 2016 – Insys Therapeutics, Inc. ("Insys" or "the Company") (NASDAQ: INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, Syndros™, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC"). Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Syndros is currently awaiting scheduling by the U.S. Drug Enforcement Administration.

"We are very pleased to announce FDA approval of Syndros. We believe that Syndros will be an important new treatment option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with weight loss in AIDS," said the Company’s Chairman, CEO and President, Dr. John N. Kapoor.

"Syndros is the first and only FDA approved dronabinol solution for oral use. It is a liquid that is easy-to-swallow and allows for the dosage to be titrated to clinical effect. Once Syndros has been opened, it does not need to be refrigerated for 28 days. We believe that these product features coupled with patient support services will prove to be important differentiators for patients and prescribers and will be key drivers of a successful market launch and sustained growth. We expect that Syndros’ attractive profile will enable rapid market conversion and expansion, making for a significant long-term commercial opportunity for Insys." added Dr. Kapoor.

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.

Indications

AIDS

Syndros™ is approved for anorexia associated with weight loss in patients with AIDS.

Oncology

Syndros™ 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 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 worsen 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 Therapeutics, Inc.

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 addresses the clinical shortcomings of existing commercial products. Insys currently markets one product, Subsys® (fentanyl sublingual spray) but has received approval for the marketing of Syndros™ (dronabinol oral solution), 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 developing a pipeline of sublingual sprays, as well as pharmaceutical cannabidiol. Insys is committed to developing medications for potentially treating addiction to opioids, opioid overdose, epilepsy and other disease areas with high unmet need.

Subsys® and Syndros™ are trademarks of Insys Therapeutics, Inc.

Forward-Looking Statements

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 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, 2015 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.

Investor Contact:
Lisa M. Wilson
President
In-Site Communications, Inc.
212-452-2793