GW Pharmaceuticals announced that the US Drug Enforcement Administration (DEA) has rescheduled Epidiolex (cannabidiol) Oral Solution to a Schedule V agent, the lowest restriction classification.
Epidiolex Oral Solution was approved in June 2018 for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients aged ≥2 years. It contains the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, a type of cannabinoid that does not produce the high associated with marijuana.
Drugs with a Schedule V classification have proven medical use and low abuse potential. The DEA’s decision was supported by non-clinical and clinical data that assessed the potential for abuse with Epidiolex. Vimpat (lacosamide), Briviact (brivaracetam), and Lyrica (pregabalin) are other anti-epileptic drugs in the Schedule V group. Other cannabidiol preparations that are not approved by the Food and Drug Administration (FDA) are still classified within Schedule I.
Epidiolex Oral Solution will be available as a 100mg/mL strength, strawberry-flavored solution. The Company stated that the product is expected to launch within the next 6 weeks.
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