Relief can be possible for both patients and caregivers.

Jon, age 18 | EPIDIOLEX patient living with LGS
When a seizure strikes, it hits the patient the hardest. But it also affects everything and everyone around them—especially caregivers.

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.

Zach, age 30 | EPIDIOLEX patient living with Dravet

EPIDIOLEX clinical trials in LGS and Dravet

EPIDIOLEX is the first and only FDA-approved prescription CBD. EPIDIOLEX significantly reduced seizures in patients with LGS and Dravet who had previously failed on multiple seizure medications.

More than 500 patients with LGS and Dravet 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 patients continued taking EPIDIOLEX for more than a year.

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

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

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Seizure reduction in those hardest to treat

See clinical study results

Fewer seizures in patients with LGS

EPIDIOLEX significantly reduced drop seizures.*

Monthly drop-seizure reduction over the 14-week treatment period in Study 2.

37% Reduction

EPIDIOLEX

10-mg/kg/day dose

42% Reduction

EPIDIOLEX

20-mg/kg/day dose

-VS-

17% Reduction

In the placebo group

 

In Study 2, there was a 37% reduction in monthly drop seizures on 10-mg/kg/day dose of EPIDIOLEX and a 42% reduction in drop seizures on 20-mg/kg/day dose of EPIDIOLEX compared with 17% on placebo.

In Study 1, there was a 44% monthly reduction in drop seizures on 20-mg/kg/day dose of EPIDIOLEX compared with 22% on placebo.

With EPIDIOLEX, freedom from drop seizures is possible for some patients

  • In Study 1, 4% of patients who took EPIDIOLEX 20 mg/kg/day (compared with 0% on placebo) reported no drop seizures

  • In Study 2, 4% of patients who took EPIDIOLEX 10 mg/kg/day and 7% who took EPIDIOLEX 20 mg/kg/day (compared with 1% on placebo) reported no drop seizures

3x more patients with LGS saw a 75% or greater reduction

in their drop seizures with EPIDIOLEX 10 mg/kg/day (11%) compared with placebo (3%) in Study 2.

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 72-week open-label phase.

*Drop seizures include several seizure types: 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 patients with Dravet

EPIDIOLEX significantly reduced convulsive seizures.*

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

39% Reduction

EPIDIOLEX

20-mg/kg/day dose

-VS-

13% Reduction

In the placebo group

 

There was a 39% reduction in monthly convulsive seizures on 20-mg/kg/day dose of EPIDIOLEX compared with 13% on placebo.

With EPIDIOLEX, freedom from convulsive seizures is possible for some patients

7% of patients who took EPIDIOLEX 20 mg/kg/day (compared with 0 patients taking placebo) reported no convulsive seizures.

Nearly 2x more patients with Dravet saw a 75% or greater reduction

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

Patients who stayed on EPIDIOLEX after the initial trial maintained seizure reduction in a 72-week 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 are sleepiness, decreased appetite, diarrhea, increase in liver enzymes, feeling very tired and weak, rash, sleep problems, and infections
  • Many side effects cleared up within 4 weeks of onset and most resolved throughout the 14-week study
  • Adverse reactions were similar across LGS and Dravet in pediatric and adult patients
  • In controlled studies, the rate of discontinuation (patients who stopped taking the medicine) for any adverse event 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 adverse event was 12%
  • The most frequent causes of discontinuation were increase in liver enzymes and sleepiness
  • 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 cause you to feel sleepy, which may get better over time. Other medicines (eg, clobazam) or alcohol may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how EPIDIOLEX affects you.

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 | EPIDIOLEX patient living with LGS

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.

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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