Clinicians & Researchers

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Epilepsy Clinical Programs

GW’s Epidiolex® development includes two distinct programs:

FDA-authorized clinical trials program

  • GW has commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine. Target indications currently include Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex, and Infantile Spasms.
  • GW’s current Phase 3 pivotal trials program for Epidiolex includes two Phase 3 trials in Dravet syndrome, two in LGS, one in TSC, and one in IS. The first two of these Phase 3 trials, one in Dravet syndrome and one in LGS, have showed significantly greater reductions in specific seizures when patients received Epidiolex compared to placebo. (see GW press releases: 14 March & 27 June 2016, 26 September 2016).

FDA-authorized, independent Physician-led program or Expanded Access (which are at times called Compassionate Use programs in some countries) and for which GW supplies Epidiolex*

  • The FDA may authorize expanded access programs to facilitate access to investigational drugs for treatment use for patients with a serious or immediately life-threatening disease or condition who lack therapeutic alternatives. This is done through FDA granting Investigational New Drug (IND) applications to the sponsoring physician.
  • The FDA has granted individual patient emergency INDs to physicians as well as INDs to physicians and state programs to treat groups of children and young adults suffering from intractable epilepsy with Epidiolex.
  • The most recent physician-reported data from this Expanded Access Program was presented in December 2015 at the American Epilepsy Society’s annual meeting. Results from 261 patients receiving Epidiolex under these INDs showed promising signals of clinical effect in reducing seizures (view press release and poster).

Medical Congress Participation

For Physicians and/or Sites Interested in Clinical Trials

If you are interested in working with GW regarding our current clinical trials or new investigator-initiated clinical research, please send site and investigator information to GW via email to: medicalinformation@gwpharm.com

If you are interested in working with GW regarding our current clinical trials or new investigator-initiated clinical research, please send site and investigator information to GW via email.

For Physicians and/or Sites Interested in Clinical Trials