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EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the U.S. FDA for use in the U.S. and the European Commission for use in the European Union, is an oral solution which contains highly purified cannabidiol.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidyolex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2021
Details:
Jazz Pharmaceuticals adds third high-growth commercial franchise: Epidiolex® (cannabidiol) oral solution is a transformative treatment for childhood-onset epilepsy that provides a critical therapeutic option for refractory seizures.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidiolex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jazz Pharmaceuticals
Deal Size: $7,200.0 million Upfront Cash: $7,200.0 million
Deal Type: Acquisition May 05, 2021
Details:
GW Pharmaceuticals has received European Commission (EC) approval for the type II variation application for Epidyolex (cannabidiol), as an adjunctive treatment of seizures associated with tuberous sclerosis complex (TSC) for patients two years of age and older.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidyolex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2021
Details:
With this acquisition, Jazz Pharma adds high-growth commercial franchise to Neuroscience portfolio with Epidiolex®, the first and only FDA-approved prescription cannabidiol medicine and a potential near-term blockbuster.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidiolex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jazz Pharmaceuticals
Deal Size: $7,200.0 million Upfront Cash: $7,200.0 million
Deal Type: Acquisition February 03, 2021
Details:
The study found that individuals treated with EPIDIOLEX 25 mg/kg/day or 50 mg/kg/day experienced a significantly greater reduction in TSC-associated seizures (48.6% for 25 mg/kg/day and 47.5% for 50 mg/kg/day) compared to placebo.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidiolex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2020
Details:
The study is a Phase 3, double-blind, parallel, placebo-controlled study that will evaluate the safety and efficacy of nabiximols for spasm frequency over a 12-week period and is expected to enroll 446 participants.
Lead Product(s): Tetrahydrocannabinol,Cannabidiol
Therapeutic Area: Neurology Product Name: Nabiximols
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2020
Details:
Australian Therapeutic Goods Administration (TGA) has approved EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidyolex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2020
Details:
U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidiolex
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 31, 2020
Details:
Five new MS Spasticity Phase 3 trials are expected to commence in H2 2020 (2) and H1 2021 (3), any one of which the company believes could enable a NDA submission.
Lead Product(s): Tetrahydrocannabinol,Cannabidiol
Therapeutic Area: Neurology Product Name: Nabiximols
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
U.S. FDA has accepted for filing with Priority Review its recently submitted supplemental New Drug Application for the use of EPIDIOLEX CV to treat seizures in Tuberous Sclerosis Complex.
Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
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