GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data at the 2021 American Academy of Neurology (AAN) ...
April 13 2021 - 7:30AM
GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the
science, development, and commercialization of cannabinoid
prescription medicines, along with U.S. subsidiary Greenwich
Biosciences, announced today that the company will present results
from completed trials of EPIDIOLEX® (cannabidiol) oral solution and
nabiximols, known as Sativex® outside of the U.S., at the virtual
American Academy of Neurology (AAN) Annual Meeting taking place
April 17-22. The company will also present findings of a survey in
partnership with the North American Research Committee on Multiple
Sclerosis (NARCOMS) – the world’s largest voluntary, patient-driven
multiple sclerosis (MS) registry – highlighting the prevalence of
cannabis use among people with MS. Additionally, the company will
share an update on cannabis-based products, including the
evidence-based pathway to FDA approval and related regulatory
challenges.
“AAN provides us with an opportunity to continue
sharing the safety and efficacy data of EPIDIOLEX in the treatment
of tuberous sclerosis complex and other treatment-resistant forms
of epilepsy,” said Justin Gover, Chief Executive Officer, GW
Pharmaceuticals. “We will also highlight the potential value of
nabiximols for people living with spasticity associated with
multiple sclerosis as we continue to advance the product in
clinical trials with a view to seeking U.S. regulatory approval. We
are committed to building the body of evidence which proves
cannabinoid medicines can be well characterized and meet the
highest standards for FDA approval – rigorously studied and
consistently manufactured – so that neurologists can feel confident
prescribing them to those in need.”
2021 AAN presentations will include:All posters
will be available in the Virtual Poster Hall for the duration of
AAN.
EPIDIOLEX Posters:
- P7.016: Efficacy and Safety of
Cannabidiol (CBD) in Patients with Treatment-Resistant Epilepsies
(TREs) in the Expanded Access Program (EAP): Additional Efficacy
Data for Convulsive and Nonconvulsive Seizure Types – Lyons et
al.
- P7.025: Long-term Efficacy and
Safety of Cannabidiol (CBD) in Patients with Tuberous Sclerosis
Complex (TSC): 4-year Results from the Expanded Access Program
(EAP) – Weinstock et al.
- P7.004: Efficacy of Add-on
Cannabidiol (CBD) Treatment in Patients with Tuberous Sclerosis
Complex (TSC) and a History of Infantile Spasms (IS): Post Hoc
Analysis of Phase 3 Trial GWPCARE6 – Sparagana et al.
- P7.002: Long-term Safety and
Efficacy of Add-on Cannabidiol (CBD) for Treatment of Seizures
Associated with Tuberous Sclerosis Complex (TSC) in an Open-Label
Extension (OLE) Trial (GWPCARE6) – Wheless et al.
Nabiximols Posters:
- P15.115: Prevalence of Cannabis Use
and Associated Factors Among People with Multiple Sclerosis (PwMS):
A 2020 NARCOMS Survey – Salter et al.
- P15.181: Study of nabiximols in
persons with multiple sclerosis (PwMS) with inadequately managed
spasticity: post hoc analyses of a controlled enrichment design
study – Ben-Zacharia et al.
- P15.185: Effect of nabiximols
cannabinoid oral-mucosal spray on depressive symptoms, suicidality,
and cognition in persons with multiple sclerosis (PwMS) – DeLuca et
al.
Additional company activities (accessible in the AAN
Virtual Exhibit Hall):
- EPIDIOLEX Virtual Booth
- Cannabinoid Clinical Virtual Booth
- Industry Therapeutic Update, a discussion exploring the
evidence-based pathway to FDA approval and the regulatory
challenges facing cannabis-based products (April 19, 2021 at 7 p.m.
ET)
About EPIDIOLEX® (cannabidiol) oral
solutionEPIDIOLEX® (cannabidiol) oral solution, a
pharmaceutical formulation of highly purified cannabidiol (CBD), is
the first in a new class of anti-epileptic medications with a novel
mechanism of action, and the first prescription, plant-derived
cannabis-based medicine approved by the U.S. Food and Drug
Administration (FDA). In the U.S., EPIDIOLEX is indicated for the
treatment of seizures associated with Lennox-Gastaut syndrome
(LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in
patients one year of age and older. Epidiolex has received approval
in the European Union under the tradename EPIDYOLEX® for adjunctive
use in conjunction with clobazam to treat seizures associated with
LGS and Dravet syndrome in patients two years and older.
EPIDIOLEX/EPIDYOLEX has received Orphan Drug Designation from the
FDA and the EMA for the treatment of seizures associated with
Dravet syndrome, LGS and TSC, each of which are severe
childhood-onset, drug-resistant syndromes and is under EMA review
for the treatment of TSC. Important safety and prescribing
information for EPIDIOLEX is available at Epidiolex.com.
Important Safety InformationImportant safety
information for EPIDIOLEX is available at EPIDIOLEX.com.
About NabiximolsNabiximols is
in pivotal Phase 3 development in the United States for the
treatment of MS spasticity. The U.S. commercial rights are owned by
GW. In addition to MS spasticity, GW expects to develop nabiximols
in Spinal Cord Injury spasticity.
Nabiximols is a complex botanical medicine
formulated from extracts of the cannabis plant that contains the
cannabinoids THC and CBD and also contains other constituents,
including non-cannabinoid plant components, such as terpenes,
sterols, and triglycerides. The product is administered as an oral
spray.
Nabiximols is known as Sativex® outside of the
U.S. and is indicated in 29 countries as a treatment for symptom
improvement in adult patients with moderate to severe spasticity
due to multiple sclerosis (MS) who have not responded adequately to
other anti-spasticity medication and who demonstrate clinically
significant improvement in spasticity related symptoms during an
initial trial of therapy. These approvals were based on multiple
pivotal trials conducted in Europe. Nabiximols is currently not
approved for any indication in the U.S.
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.Founded in 1998, GW is a
biopharmaceutical company focused on discovering, developing and
commercializing novel therapeutics from its proprietary cannabinoid
product platform in a broad range of disease areas. The Company’s
lead product, EPIDIOLEX® (cannabidiol) oral solution, is
commercialized in the U.S. by its U.S. subsidiary Greenwich
Biosciences for the treatment of seizures associated with
Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous
sclerosis complex (TSC) in patients one year of age and older. This
product has received approval in the European Union under the
tradename EPIDYOLEX® for the adjunctive treatment of seizures
associated with LGS or Dravet syndrome in conjunction with clobazam
in patients two years and older and is under EMA review for the
treatment of TSC. The Company has a deep pipeline of additional
cannabinoid product candidates, in particular nabiximols, for which
the Company is advancing multiple late-stage clinical programs in
order to seek FDA approval in the treatment of spasticity
associated with multiple sclerosis and spinal cord injury. The
Company has additional cannabinoid product candidates in clinical
trials for autism and schizophrenia. For further information,
please visit www.gwpharm.com.
Enquiries:
Investors |
|
Scott Giacobello, Chief Financial Officer |
760-795-2200 |
Media: |
|
Kristen Cardillo, VP, Corporate CommunicationsChristy Curran, Sam
Brown Inc. Healthcare Communications |
760-579-6628 615-414-8668 |
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