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GW Pharmaceuticals plc purified, plant-derived cannabidiol (CBD), cal program. “I am delighted that my with LGS and Dravet syndrome.
a cannabinoid lacking the high associated
physician colleagues and I will now have
“For those living with intractable
and its U.S. Subsidiary with marijuana, and the first in a new cat- the option of a prescription cannabidiol seizures caused by LGS and Dravet syn-
Greenwich Biosciences egory of anti-epileptic drugs (AEDs). that has undergone the rigor of controlled drome, EPIDIOLEX represents a true
Product availability is pending reschedul-
trials and been approved by the FDA to
medical advancement,” said Philip
Announce FDA Approval ing which is expected to occur within 90 treat both children and adults.” Gattone, president and CEO of the
days.
Epilepsy Foundation. “Clinical develop-
“LGS and Dravet syndrome are two of
of EPIDIOLEX® “Today’s approval of EPIDIOLEX is a the most severe and difficult-to-treat forms ment for these rare and severe conditions
(cannabidiol) oral solu- historic milestone, offering patients and of childhood-onset epilepsy. These chil- is essential, and today’s news brings hope
their families the first and only FDA-
dren and their families face a long and
for these patients and their families that a
tion – the First Plant- approved CBD medicine to treat two challenging road and very few achieve ade- new treatment option may have the poten-
derived Cannabinoid severe, childhood-onset epilepsies,” said quate seizure control,” said Elizabeth tial to help better control their seizures.”
Thiele, M.D., director of the pediatric
Justin Gover, GW’s Chief Executive
EPIDIOLEX will be marketed in the
Prescription Medicine Officer. “This approval is the culmination epilepsy program at Massachusetts U.S. by Greenwich Biosciences, the U.S.
General Hospital, professor of neurology
subsidiary of GW Pharmaceuticals plc. As
of GW’s many years of partnership with
Approval for seizures associated patients, their families, and physicians in at Harvard Medical School and a lead part of the approval process, EPIDIOLEX
the epilepsy community to develop a investigator in the EPIDIOLEX clinical must be rescheduled from its current
with Lennox-Gastaut Syndrome much needed, novel medicine. These program. “Based on numerous clinical tri- Schedule I before it can be made available
or Dravet Syndrome, two rare, patients deserve and will soon have access als, this medication may help meet the to patients. Rescheduling is expected to
to a cannabinoid medicine that has been
need for this specific pediatric patient pop-
occur within 90 days. Access is expected
severe childhood-onset epilepsies thoroughly studied in clinical trials, man- ulation and is now the first to be approved to be similar to other branded AEDs and
ufactured to assure quality and consisten- by the FDA in Dravet syndrome.” EPIDIOLEX is expected to be available to
LONDON and CARLSBAD, Calif., June cy, and available by prescription under a The EPIDIOLEX clinical development appropriate patients by Fall 2018. More
25, 2018 (GLOBE NEWSWIRE) -- GW physician’s care.” program included three randomized, con- information can be found at
Pharmaceuticals plc (Nasdaq:GWPH) LGS and Dravet syndrome, which devel- trolled Phase 3 clinical trials and an open- Epidiolex.com.
(“GW,” “the Company” or “the Group”), a op in childhood, are rare, severe forms of label extension study. In the Phase 3 stud- Outside the U.S., this medicine is cur-
biopharmaceutical company focused on epilepsy that are notoriously treatment- ies, published in The New England rently under review by the European
discovering, developing and commercial- resistant.1,2 Most patients with LGS and Journal of Medicine7,8 and Lancet9, Medicines Agency (EMA) for the treat-
izing novel therapeutics from its propri- Dravet syndrome require multiple seizure EPIDIOLEX added to other antiepileptic ment of seizures associated with LGS and
etary cannabinoid product platform, along medications and the majority are resistant therapies significantly reduced the fre- Dravet Syndrome. An EMA decision on
with its U.S. subsidiary Greenwich to currently approved AEDs.2,3,4 The quency of seizures in patients with LGS whether to recommend approval is expect-
Biosciences, announced today that the day-to-day impact of these conditions is and Dravet syndrome. The most common ed in the first quarter of 2019.
U.S. Food and Drug Administration significant with high rates of early mortal- adverse reactions that occurred in EPIDI-
(FDA) has approved EPIDIOLEX® ity.5,6 OLEX-treated patients were somnolence; For more information on Dravet syn-
(cannabidiol) oral solution for the treat- “In my practice, I often see patients with decreased appetite; diarrhea; transaminase drome and Lennox-Gastaut syndrome,
ment of seizures associated with Lennox- these highly treatment-resistant epilepsies elevations; fatigue, malaise, and asthenia; including community support, please visit
Gastaut syndrome (LGS) or Dravet syn- who have tried and failed existing thera- rash; insomnia, sleep disorder and poor the Dravet Syndrome Foundation at
drome in patients two years of age or pies and are asking about CBD,” said Orrin quality sleep; and infections. The compa- www.dravetfoundation.org and the Lennox-
older. EPIDIOLEX is the first prescription Devinsky, M.D., of NYU Langone Health’s ny’s development program represents the Gastaut Syndrome Foundation
pharmaceutical formulation of highly- Comprehensive Epilepsy Center and a only well-controlled clinical evaluation of at www.lgsfoundation.org
lead investigator in the EPIDIOLEX clini- a cannabinoid medication for patients

Physician Advocate, Education Key to Helping
Curaleaf Opens
Patients Gain Access to Medical Cannabis First Medical

Continued from page 32 recommend medical cannabis, but many says that those who are in favor of medical Cannabis
need,” he added. choose not to or can’t because of the hos- cannabis still face an uphill battle in
Patients who turn to the black market pital system with which they are affiliat- Florida. Dispensary with
for pain relief won’t find what they need, ed,” he explained. “Some aren’t comfort- “The Republican leaders, including Gov.
according to Dr. Gordon, because no one able with it because it wasn’t taught in Rick Scott and Surgeon General and Drive Thru Service
provides a combined THC/CBD product. medical school. Secretary of the Florida Department of
“The CBD component and other helpful “Not all practices are equal, though, so Health Celeste Philip, push back at every in Florida
cannabinoids have been bred out because do your research,” he added. “Find out if level,” he said. “Even though John Morgan
they diminish the intoxicant effects of this is something that the doctor does won his smoking case, the state appealed Curaleaf has introduced its newest
THC,” he explained. “They can’t get THC every day; check their references, and even within minutes. In another trial about the customer service feature – online
in the CBD world, because in the 30 CBD see what people have to say on Facebook.” right to grow cannabis, despite winning, ordering and drive thru service for
shops in Sarasota County that sell hemp- Patients shouldn’t be embarrassed about we have to go to the Supreme Court to tes- existing customers at its Palm Harbor
based products, including smokable hemp asking how cannabis can help, either. tify again. dispensary.
flower, those products have less than a .3 “Thirty-three percent of my patients have “This will continue as long as we have Curaleaf’s Palm Harbor dispensary
percent level of THC. And you don’t know never used cannabis before,” said Dr. Republican leaders,” he said, adding that offers existing customers the conven-
if the products are clean or have mold or Gordon. “They never even knew anyone he invites politicians of all parties to visit ience of placing orders for premium
fungus. who used it! They are fascinated that peo- his clinic to learn more about the benefits quality medical cannabis products
“Only in the legitimate medical cannabis ple can use it and still pay bills and raise of medical cannabis. online with the option to pick up
world, which is very regulated, can you get kids. “I see remarkable results every day,” he orders at dispensary’s secure drive thru
both,” he added. “And every patient “The fact is, medical cannabis is not a added. “I love conventional healthcare, area, in the dispensary or via same-day
deserves to have a safer product.” Dr. social destructor,” he added. “I’ve never but there needs to be an alternative to opi- or next-day delivery service. First-time
Gordon suggests that new patients first ask had to resuscitate a cannabis addict in the oids to help people.” patients are required to visit dispensa-
their own doctors to recommend medical ER, or treat a wife who was beaten up by ry for a private consultation and
cannabis, but if that is unsuccessful, to her husband while he was on cannabis. To learn more, visit www.Venicecare.com or encouraged to take advantage of edu-
contact him or any of the other doctors on I’ve never lost a professional partner to follow CompassionatecannabisClinicofVenice cational resources available on
the state’s medical cannabis website. cannabis, like I have to drugs or alcohol.” on Facebook. cannabinoid therapies in its communi-
“Any doctor in the state can sign up to Despite its positive effects, Dr. Gordon ty meeting room.

26 July 2018 southfloridahospitalnews.com South Florida Hospital News