Sympazan®
(clobazam)
Oral Film

Expanding our commitment to epilepsy

In November 2018, we received FDA approval of Sympazan (clobazam) oral film. Sympazan is a film formulation of clobazam, a benzodiazepine used as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS).

Sympazan, with its patented PharmFilm® technology delivery system, is an innovative choice for caregivers and patients. Sympazan is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

For full prescribing information, click here.

The Sympazan Savings Card

The Sympazan Savings Card can help lower your out-of-pocket costs, if you’re an eligible patient with commercial insurance.

Depending on your insurance coverage, you may pay as little as $10 for a 30-day prescription of Sympazan. Please see Program Terms, Conditions, and Eligibility Criteria

 

Sympazan® savings card

Subject to eligibility. Restrictions apply.
See eligibility, terms, and conditions

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Take your API further

See how Sympazan can help overcome barriers to treatment

We’re working to improve the treatment experience for patients with epilepsy and their caregivers

IMPORTANT SAFETY INFORMATION

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

  • Do not stop taking SYMPAZAN without first talking to your healthcare provider. Stopping SYMPAZAN suddenly can cause serious side effects.
  • SYMPAZAN, a benzodiazepine medicine, can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.
  • SYMPAZAN can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time. Do not drive, operate heavy machinery, or do other dangerous activities until you know how SYMPAZAN affects you. SYMPAZAN may cause problems with your coordination, especially when walking or picking things up.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking SYMPAZAN because SYMPAZAN may make your sleepiness or dizziness much worse.
  • SYMPAZAN can cause withdrawal symptoms. Do not stop taking SYMPAZAN without first talking to a healthcare provider. Stopping SYMPAZAN suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps.
  • SYMPAZAN is a federally controlled substance (CIV) that can be abused or cause dependence. Keep SYMPAZAN in a safe place to prevent misuse and abuse by others. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
  • Serious skin reactions have been seen when SYMPAZAN is taken with other medicines and may require stopping its use. Do not stop taking SYMPAZAN without first talking to your healthcare provider. Call your healthcare provider immediately if you have skin blisters, rash, sores in mouth, hives or any other allergic reaction.
  • Like other antiepileptic drugs, SYMPAZAN may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms: thoughts about suicide or dying; new or worse anxiety; trouble sleeping (insomnia); dangerous impulses; attempts to commit suicide; feeling agitated or restless; new or worse depression or irritability; an extreme increase in activity and talking (mania); panic attacks; acting aggressive, angry or violent, or any other unusual changes in behavior or mood. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not take SYMPAZAN if you are allergic to clobazam or any of the ingredients in SYMPAZAN.

Before you take SYMPAZAN, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver or kidney problems; lung problems (respiratory disease); have or have had depression, mood problems, or suicidal thoughts or behavior.
  • use birth control medicine. SYMPAZAN may cause your birth control medicine to be less effective.
  • are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. SYMPAZAN may harm your unborn baby. If you become pregnant while taking SYMPAZAN, you and your healthcare provider will decide if you should continue to take SYMPAZAN and if you will take SYMPAZAN or breast feed, you should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking SYMPAZAN with certain other medicines can cause side effects or affect how well SYMPAZAN or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

The most common side effects of SYMPAZAN are: sleepiness; pain with urination; slurred speech; drooling; fever; tiredness; constipation; acting aggressive; angry; or violent; problems with breathing; cough; and difficulty sleeping. These are not all the possible side effects of SYMPAZAN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS SYMPAZAN?

SYMPAZAN is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut Syndrome in people 2 years of age or older. It is not known if SYMPAZAN is safe and effective in children less than 2 years old.

Please see full Prescribing Information, including Medication Guide with important warning.

References:

1. Integrated Clinical and Statistical Report. A pivotal, open-label, randomized, single-dose, four-period, four-arm, crossover, comparative bioavailability study of clobazam 20 mg and 10 mg oral films and ONFI® 20 mg and 10 mg tablets in healthy male and female volunteers under fasting conditions. August 2017.

2. SYMPAZAN [package insert]. Warren, NJ: Aquestive Therapeutics; November 2018.

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Please complete the form below and click SEND to receive a copy of “Overcoming Solubility and Permeability Challenges,” a case study detailing the achievements made by Aquestive’s formulation team to create the diazepam buccal film.

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Please complete this form:

  • To subscribe to receive marketing updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing info@aquestive.com or by calling 1-833-AQUESTV.

To learn how PharmFilm can transform your product or to begin a discussion about in-licensing, please complete the following form:

  • To subscribe to receive information updates about products and services from Aquestive Therapeutics, or to receive information about Aquestive-sponsored clinical trials, please check the box below. Please also review our privacy policy, which describes how we use and process your data. If for any reason you no longer wish to receive information on Aquestive-sponsored clinical trials, you can contact us at any time by emailing info@aquestive.com or by calling 1-833-AQUESTV