Three requirements for a medicine

Epidyolex complies with the principal regulatory requirements for a medicine:1

Efficacy

 

 

Studied in randomised Phase III clinical trials, evaluating efficacy and dosing compared to placebo.

 

 

 

Generally well tolerated

 

 

Comprehensive pre-clinical programme examining toxicity, drug-drug interactions, pharmacology, dosing and abuse potential; as well as extensive clinical trials.

 

 

 

Quality

 

 

Manufactured to GxP standards and complies with regulatory medicine standards, ensuring:

 

 

  • Freedom from contaminants such as pesticides, heavy metals and aflatoxins
  • Batch-to-batch consistency
  • A stable shelf life
  • Continuous investment in process and facilities

 

GxP, Good Practice.

 

 

 

 

Sign up and stay up to date

Receive promotional communications and notifications about open-label extension data, our latest conference activity, key opinions from leading researchers and prescribers in cannabinoid therapy.

References

 

1. Epidyolex Summary of Product Characteristics (Date accessed: April 2021).