With EPIDIOLEX, families have something else to share: hope

When a seizure strikes, it hits the patient the hardest. But it also affects everything and everyone around them—especially caregivers.

Jon, at age 18 | Living with LGS and taking EPIDIOLEX

Sun and Moon Graphic

The intense, around-the-clock commitment takes a toll on the family. So when medicines and other therapies fail to offer seizure reduction, it’s not just disappointing—it’s devastating.

EPIDIOLEX is
the first and only
FDA-approved
prescription CBD

EPIDIOLEX significantly reduced seizures in people with LGS, Dravet syndrome, or TSC for whom multiple previous seizure medications did not work well.

Kierstin, at age 15 | Living with TSC and taking EPIDIOLEX

Seizure reduction in those hardest to treat

See clinical study results

EPIDIOLEX reduced the frequency of seizures in TSC by half

Reduction in TSC-associated seizures* over the 16-week treatment period.

Fill 1548%Reduction

EPIDIOLEX

25-mg/kg/day dose

– VS –

Fill 1524%Reduction

In the placebo group

EPIDIOLEX® (cannabidiol) TSC Seizure Information

With EPIDIOLEX, freedom from seizures is possible for some

5% of people taking EPIDIOLEX achieved freedom from TSC-associated seizures (compared with 0% of people taking placebo).

EPIDIOLEX® (cannabidiol) TSC Seizure Reduction Information

Substantial reduction in TSC seizures with EPIDIOLEX

More people reduced their TSC seizures by 75% or more with EPIDIOLEX 25 mg/kg/day (19%), compared with 0% of people taking placebo.

EPIDIOLEX® (cannabidiol) Clinical Trial | Participant Numbers for TSC

More than 200 people with TSC took part in a clinical trial to determine if EPIDIOLEX reduced the rate of seizures associated with TSC. After this trial was completed, almost all patients continued taking EPIDIOLEX as part of an extension of the study.

EPIDIOLEX® (cannabidiol) Clinical Trial | Seizure Medicines for TSC

People with TSC in the EPIDIOLEX clinical trial had typically failed on 4 prior seizure medicines. They were also taking an average of 3 seizure medicines at the time of the study, but their seizures were still uncontrolled.

EPIDIOLEX® (cannabidiol) Clinical Trial | Common Side Effects for TSC

The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.

1/3

EPIDIOLEX can be used in combination with many commonly prescribed seizure medicines. In this study, the most common seizure medicines patients had taken, while also taking EPIDIOLEX, were valproate, vigabatrin, levetiracetam, and clobazam.

Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 48-week open-label phase.

*TSC-associated seizures included different types of partial onset (focal) seizures and generalized seizures.

Fewer seizures in people living with LGS

EPIDIOLEX significantly reduced drop seizures in people living with LGS

Monthly drop-seizure* reduction over the 14-week treatment period.

Fill 1537%Reduction

EPIDIOLEX

10-mg/kg/day dose

Fill 1542%Reduction

EPIDIOLEX

20-mg/kg/day dose

– VS –

Fill 1517%Reduction

In the placebo group

In another study, there was a 44% monthly reduction in drop seizures among patients taking EPIDIOLEX in the 20-mg/kg/day group, compared with a 22% reduction taking placebo.

Group 13

With EPIDIOLEX, freedom from drop seizures is possible for some

  • 4% of people taking EPIDIOLEX 20 mg/kg/day (compared with 0% of people taking placebo) reported no drop seizures

  • In another study, 4% of people taking EPIDIOLEX 10 mg/kg/day and 7% who took EPIDIOLEX 20 mg/kg/day (compared with 1% of people taking placebo) reported no drop seizures

*/Icons/Art/+ Copy

3x more people living with LGS saw a substantial reduction of 75% or greater

in their drop seizures with EPIDIOLEX 10 mg/kg/day (11%), compared with placebo (3%).

EPIDIOLEX® (cannabidiol) Clinical Trial | Participant Numbers for LGS and Dravet

More than 500 people with LGS and Dravet syndrome took part in 3 clinical studies—the largest placebo-controlled, clinical study program of these conditions to date. Even after these trials were completed, the majority of people continued taking EPIDIOLEX for more than a year.

EPIDIOLEX® (cannabidiol) Clinical Trial | Seizure Medicines for LGS and Dravet

EPIDIOLEX clinical trials included people who had typically failed on 4-6 prior seizure medicines. These people were typically also taking 3 seizure medicines at the time, but their seizures were still uncontrolled.

EPIDIOLEX® (cannabidiol) Clinical Trial | Common Side Effects for LGS and Dravet

The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.

1/3

At 20-mg/kg/day doses, there was a somewhat greater reduction in seizure rates than with 10-mg/kg/day doses; however, there was also an increase in EPIDIOLEX side effects.

58% of caregivers reported an improvement in their loved one's overall condition on the Subject/Caregiver Impression of Change (S/CGIC) scale with EPIDIOLEX, compared with 34% of those whose loved one was on placebo. The S/CGIC is a 7-point scale that ranges from "Very Much Improved" to "Very Much Worse," evaluating patient or caregiver assessment of the patient's overall condition from the beginning of the study to the end of the study.

Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.

*Drop seizures included tonic, atonic, and tonic-clonic that led, or could have led, to a fall or injury.

During the 12-week maintenance period.

Fewer seizures in people living with Dravet syndrome

EPIDIOLEX reduced convulsive seizures in people living with Dravet syndrome

Monthly convulsive-seizure* reduction over the 14-week treatment period.

Fill 1539%Reduction

EPIDIOLEX

20-mg/kg/day dose

– VS –

Fill 1513%Reduction

In the placebo group

Group 13

With EPIDIOLEX, freedom from convulsive seizures is possible for some

  • 7% of people taking EPIDIOLEX 20 mg/kg/day (compared with 0% of people taking placebo) reported no convulsive seizures

*/Icons/Art/+ Copy

Nearly 2x more people living with Dravet syndrome saw a substantial reduction of 75% or greater

in their convulsive seizures with EPIDIOLEX 20 mg/kg/day (23%), compared with placebo (12%).

EPIDIOLEX® (cannabidiol) Clinical Trial | Participant Numbers for LGS and Dravet

More than 500 people with LGS and Dravet syndrome took part in 3 clinical studies—the largest placebo-controlled, clinical study program of these conditions to date. Even after these trials were completed, the majority of people continued taking EPIDIOLEX for more than a year.

EPIDIOLEX® (cannabidiol) Clinical Trial | Seizure Medicines for LGS and Dravet

EPIDIOLEX clinical trials included people who had typically failed on 4-6 prior seizure medicines. These people were typically also taking 3 seizure medicines at the time, but their seizures were still uncontrolled.

EPIDIOLEX® (cannabidiol) Clinical Trial | Common Side Effects for LGS and Dravet

The most common side effects of EPIDIOLEX include increase in liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections.

1/3

Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 3-year open-label phase.

*Convulsive seizures include several seizure types: tonic, tonic-clonic, atonic, and clonic.

During the 12-week maintenance period.

EPIDIOLEX® (cannabidiol) Bottle with Facts about EPIODELEX®

Things to know about EPIDIOLEX safety and tolerability

Common EPIDIOLEX side effects and interactions

EPIDIOLEX may cause liver problems. Your doctor may order blood tests to check your liver before you start taking EPIDIOLEX and during treatment. In some cases, EPIDIOLEX treatment may need to be stopped. Call your doctor right away if you start to have any of these signs and symptoms of liver problems during treatment with EPIDIOLEX:

  • Loss of appetite, nausea, vomiting
  • Fever, feeling unwell, unusual tiredness
  • Yellowing of the skin or the whites of the eyes (jaundice)
  • Itching
  • Unusual darkening of the urine
  • Right upper stomach area pain or discomfort

Your doctor may order blood tests to monitor for other EPIDIOLEX side effects.

EPIDIOLEX may cause you to feel sleepy, which may get better over time. Other medicines (e.g., clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.

Like other antiepileptic drugs, EPIDIOLEX may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempt to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings
  • Keep all follow-up visits with your healthcare provider as scheduled

Do not stop taking EPIDIOLEX without first talking to your healthcare provider. Stopping a seizure medicine such as EPIDIOLEX suddenly can cause you to have seizures more often or seizures that do not stop (status epilepticus).

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not take EPIDIOLEX if you are allergic to cannabidiol or any other ingredients in EPIDIOLEX.

  • The most common side effects include increased liver enzymes, sleepiness, decreased appetite, diarrhea, fever, vomiting, feeling very tired and weak, rash, sleep problems, and infections
  • Across studies in LGS, Dravet syndrome, and TSC, EPIDIOLEX was found to have a consistent safety profile in both children and adults
  • In the LGS and Dravet syndrome studies, the rate of discontinuation (patients who stopped taking the medicine) for any side effect was 1% for patients taking placebo and 3% for patients taking EPIDIOLEX 10 mg/kg/day. For patients taking EPIDIOLEX 20 mg/kg/day, the rate of discontinuation for any side effect was 12%
  • In the TSC study, the rate of discontinuation for any side effect was 3% for patients taking placebo and 11% for patients taking EPIDIOLEX 25 mg/kg/day
  • The most frequent causes of discontinuation were increased in liver enzymes and sleepiness in the LGS and Dravet syndrome studies, and rash in the TSC study
  • EPIDIOLEX can cause weight loss
  • Your doctor may also order blood tests to look out for other side effects
  • These are not all of the possible EPIDIOLEX side effects. For more information, ask your healthcare provider or pharmacist

EPIDIOLEX may interact with some seizure medicines or other medicines you are taking. Do not start or stop other medicines without talking to your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.

Aaron, age 30 | Living with LGS and taking EPIDIOLEX

The EPIDIOLEX difference: Why FDA approval matters

Learn what sets EPIDIOLEX apart from non–FDA approved CBD products.

How EPIDIOLEX is grown & manufactured

What’s the EPIDIOLEX difference? It starts with how it’s grown and manufactured. From our (green)house to yours, there’s a lot of detail that goes into making every bottle of EPIDIOLEX.

WATCH FULL VIDEO

How EPIDIOLEX is tested & FDA approved

Next, is how it’s tested and approved. EPIDIOLEX is FDA approved, which among many things, means that it has a safety and efficacy profile that has been thoroughly evaluated in clinical trials.

WATCH FULL VIDEO

How EPIDIOLEX is prescribed & delivered

Lastly, is how it’s prescribed and delivered. Unlike non–FDA approved CBD products, you can only get EPIDIOLEX through a doctor’s prescription, which gives you access to medical guidance, potential insurance coverage, and continued support and resources.

WATCH FULL VIDEO