GW Pharmaceuticals plc and Its U.S. Subsidiary Greenwich Biosciences, Inc. Announce That EPIDIOLEX® (cannabidiol) Oral Solut...
April 06 2020 - 9:00AM
GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the
Group”), a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its
proprietary cannabinoid platform, along with its U.S. subsidiary
Greenwich Biosciences, Inc., announced today that it has received
notification from the United States Drug Enforcement Administration
(DEA) confirming that EPIDIOLEX® (cannabidiol) is no longer subject
to the Controlled Substances Act (CSA). This change takes
effect immediately.
“This notification from DEA fully establishes
that EPIDIOLEX, the only CBD medicine approved by FDA, is no longer
a controlled substance under the federal Controlled Substances
Act,” said Justin Gover, GW’s Chief Executive Officer. “We
would like to thank DEA for confirming the non-controlled status of
this medicine. Importantly, the descheduling of EPIDIOLEX has the
potential to further ease patient access to this important therapy
for patients living with Lennox-Gastaut Syndrome and Dravet
syndrome, two of the most debilitating forms of epilepsy.”
EPIDIOLEX, which was launched in the United
States on November 1, 2018 after approval by FDA for the
treatment of seizures associated with Lennox-Gastaut Syndrome (LGS)
or Dravet syndrome in patients two years of age or older, is the
first prescription pharmaceutical formulation of highly purified,
plant-derived cannabidiol (CBD), and the first in a new category of
anti-epileptic drugs.
Following FDA approval, EPIDIOLEX was initially
placed in Schedule V of the CSA. Following receipt of this DEA
notification, GW has filed a post-approval supplement with FDA to
remove Schedule V designation from EPIDIOLEX.
DEA’s letter means that all federal
controlled-substance restrictions have been removed for EPIDIOLEX.
The Company will now begin the process of implementing these
changes at the state level and through the EPIDIOLEX distribution
network. Once this process is completed in each state,
prescriptions for EPIDIOLEX, like other non-controlled medicines,
will be valid for one year and can be easily transferred between
pharmacies. The descheduling of EPIDIOLEX also enables physicians
to prescribe this breakthrough medicine free of the requirements of
state prescription drug monitoring programs.
The most common adverse reactions that occurred
in EPIDIOLEX-treated patients were somnolence, decreased appetite,
diarrhea, transaminase elevations, fatigue, malaise, and asthenia,
rash, insomnia, sleep disorder and poor-quality sleep, and
infections. The medicine is marketed in the United States by
Greenwich Biosciences, the U.S. subsidiary of GW Pharmaceuticals
plc. More information, including the product label, can be found at
Epidiolex.com.
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) or Dravet syndrome in patients two
years of age or older. This product has received approval in the
European Union under the tradename EPIDYOLEX®. The Company has
submitted a supplemental New Drug Application (sNDA) to the U.S.
Food and Drug Administration (FDA) to expand the indication for
Epidiolex to include seizures associated with Tuberous Sclerosis
Complex (TSC), for which it has reported positive Phase 3 data, and
is carrying out a Phase 3 trial in Rett syndrome. 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, as well as for the treatment of PTSD. The
Company has additional cannabinoid product candidates in Phase 2
trials for autism and schizophrenia. For further information,
please visit www.gwpharm.com.
About EPIDIOLEX® (cannabidiol) oral
solution
EPIDIOLEX® (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)
or Dravet syndrome in patients two years of age or older. A
supplemental New Drug Application (sNDA) has been submitted to the
FDA for the treatment of seizures associated with tuberous
sclerosis complex (TSC). 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. 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.
Forward-looking statements
This news release contains forward-looking
statements that reflect GW's current expectations regarding future
events, including statements regarding the timing and outcomes of
regulatory decisions. Forward-looking statements involve risks and
uncertainties. Actual events could differ materially from those
projected herein and depend on a number of factors, including the
risks and uncertainties which can be found in GW’s filings with the
U.S. Securities and Exchange Commission. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
GW undertakes no obligation to update or revise the information
contained in this press release, whether as a result of new
information, future events or circumstances or otherwise.
Enquiries:
GW Pharmaceuticals plc |
|
Stephen Schultz, VP Investor Relations (U.S.) |
917 280 2424 / 401 500 6570 |
|
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U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
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Christy Curran Mike Beyer |
615 414 8668 312 961 2502 |
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