The FDA is currently reviewing at least one CBD derived therapy (Epidiolex) that shows promise for the treatment of Dravet and Lennox-Gastaut syndromes (LGS), tuberous sclerosis complex (TSC) and potentially other rare epilepsies. This potential treatment option has both Orphan Drug Designation and Fast Track Designation from the FDA for Dravet syndrome and also Orphan Drug Designation for LGS and TSC, another type of rare epilepsy. Given the Fast Track Designation, this potential treatment option could be available as soon as early 2018. Since pure CBD is a Schedule I substance under most state schedules, state action is needed to ensure proper rescheduling of FDA-approved treatments derived from CBD.
Unless states act to ensure access to new treatments derived from CBD that are approved by FDA and scheduled by DEA, these therapies would not be made available to individuals living with uncontrolled seizures. Therefore, we are urging states to begin to explore how they can take steps to ensure access to this potentially lifesaving treatment option if approved by the FDA.
Check out the state rescheduling model legislation:
Model Language - State Rescheduling for Pathway for FDA Approved Therapies Derived from CBD
In April 2017, six prominent New York physicians wrote to the chairs of the New York State Senate & House Health Committees in support of access to FDA-approved CBD therapies for people with epilepsy. All six physicians were investigators for clinical trials involving the use of CBD to treat epilepsy, and saw firsthand the reductions in seizures that some people with epilepsy experience after using CBD-derived products. Read these letters below.
NY physician investigators letter to Gottfried (April 3, 2017)
NY physician investigators letter to Hannon (April 3, 2017)