The U.S. Food and Drug Administration (FDA) has accepted a new drug application from Jazz Pharmaceuticals for a capsule formulation of cannabidiol (CBD), setting April 16, 2027, as its target date for a regulatory decision. The development could introduce a new way for patients with certain forms of epilepsy to receive the marijuana-derived medication currently sold as Epidiolex.
According to a November 2 filing with the U.S. Securities and Exchange Commission (SEC), Jazz submitted the application in mid-2026 to expand treatment options for patients already eligible to receive prescription cannabidiol. The company said the capsule formulation is intended to increase flexibility for patients and broaden use of the medication within its existing approved indications.
Epidiolex, which received its initial FDA approval in June 2018, is currently available as an oral solution. It is approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex in patients at least one year old.
The proposed capsule formulation would offer an alternative to the liquid medication, potentially making treatment more convenient for some patients. During the company’s November 2 earnings call, Jazz officials said the capsules could improve accessibility and treatment adherence, particularly among certain adult patient populations.
The April 16 deadline is a target action date established under the Prescription Drug User Fee Act (PDUFA), the federal framework governing FDA review timelines. By that date, the agency is expected to issue a decision on the application, although the review could conclude with approval, a request for additional information or another regulatory action.
Beyond the pending application, Jazz is investigating whether its cannabidiol capsules could treat additional forms of epilepsy. The company disclosed that it has announced a Phase 2/3 clinical trial evaluating the formulation’s safety and effectiveness in patients with juvenile myoclonic epilepsy, a condition that is not among Epidiolex’s currently approved indications.
Jazz is also conducting research involving its existing cannabidiol oral solution. This includes a Phase 1b trial examining its effectiveness for focal-onset seizures, a Phase 3b/4 study evaluating dosing strategies in adults with Lennox-Gastaut syndrome, and a Phase 3 trial involving developmental and epileptic encephalopathy.
The regulatory development comes as Epidiolex remains one of Jazz’s major pharmaceutical products. In its third-quarter financial report, the company reported approximately $295 million in Epidiolex/Epidyolex sales, down 2% from the same quarter in 2025. Sales during the first nine months of 2026 reached $837.3 million, an increase of approximately 8% from the previous year.
If approved, the capsules would expand the available formulations of the first FDA-approved prescription medication containing purified cannabidiol derived from marijuana, nearly nine years after the original approval of Epidiolex.
