FDA-approved First cannabis-based drug (Epidiolex) For Epilepsy

Epidiolex, the very first cannabis-based drug approved by the US Food and Drug Administration, is currently available by prescription in all 50 states.

It was found in 1940 and originally thought to not be pharmaceutically active. It’s one of 113 cannabinoids found in hemp plants, accounting for as many as 40 percent of the plant extract.

The twice-daily oral remedy is approved for use in patients 2 or older to treat two different types of epileptic syndromes: Dravet syndrome, an uncommon hereditary disorder of the brain which starts in the very first period of existence, also Lennox-Gastaut syndrome, a sort of epilepsy with a number of types of seizures which starts in early childhood.

Animal studies reveal anticonvulsant efficacy in numerous species and versions. Anecdotal reports indicate effectiveness in children with treatment-resistant epilepsies (TRE), notably Dravet syndrome. Here we report preliminary outcomes in kids with TRE within an expanded access therapy plan.

Epidiolex Uses

  • Medicine suggested for the treatment of seizures related to Lennox-Gastaut syndrome or Dravet syndrome,
  • Two rare, acute childhood-onset epilepsies –

Mechanism

The specific mechanism where the cannabidiol comprised in EPIDIOLEX® generates anticonvulsant effects isn’t known. Clinical data indicates that the cannabidiol doesn’t produce the anticonvulsant effects through interaction with cannabinoid receptors.

Cannabidiol has very low affinity for its cannabinoid CB1 and CB2 receptors but is also said to act as a direct antagonist of those receptors. In the Exact Same time, it might potentiate the effects of THC by Raising CB1 receptor density or via a different CB1receptor-related mechanism.

Epidiolex Side effects

Common medication side effects, such as:

  • Reduced appetite
  • Diarrhea
  • Elevated liver enzymes
  • Infection
  • Diseases
  • Insomnia
  • Malaise and fatigue
  • Rash
  • Sedation and lethargy
  • Sleep disease and poor sleep

Serious risks might occur with Epidiolex, including the following:

  • Efforts to commit suicide
  • Aggression
  • Feelings of agitation
  • Panic attacks
  • New or worsening depression
  • Thinking about suicide
  • Growth in liver enzymes

“We are delighted to announce that EPIDIOLEX is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals.

“Because these patients have historically not responded well to available seizure medications, there has been a dire need for new therapies that aim to reduce the frequency and impact of seizures. We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”

Epidiolex Dose

Epidiolex dosing is based on body weight.

  • The recommended beginning dose of Epidiolex is 2.5 mg/kg twice per day.
  • After one week, the dose could be raised to a maintenance dose of 5 mg/kg twice each day.
  • If additional seizure reduction is needed, the maximum dose of Epidiolex in 10 mg/kg twice per day or 20 mg/kg once daily could be given.
  • The higher dose may lead to an increase in adverse reactions, though research have shown that Epidiolex is successful and has a favorable safety profile in both doses studied.
0Shares

Leave a Comment