Wired News – FDA Accepted GW Pharma's NDA Filing for Epidiolex(R) in the Treatment of Lennox-Gastaut Syndrome and Dravet Syndrome

LONDON, UK / ACCESSWIRE / January 02, 2018 / Active-Investors.com has just released a free research report on GW Pharma PLC (NASDAQ: GWPH). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=GWPH as the Company's latest news hit the wire. On December 28, 2017, the Company declared that the US Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Epidiolex® (cannabidiol), an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018. Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, GW Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=GWPH

The Company announced results from completed Phase-3 trials of Epidiolex® in LGS and Dravet syndrome along with other supportive data in November 2017.

GW Completed Rolling NDA to FDA for Epidiolex® in October

On October 30, 2017, the Company, along with its US subsidiary Greenwich Biosciences, completed the rolling submission of an NDA to FDA for Epidiolex® as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. GW Pharma had received Rare Pediatric Disease and Orphan Drug Designations from the FDA for Epidiolex® in the treatment of both LGS and Dravet syndrome.

FDA Granted Orphan Drug Designation to Zogenix's ZX008 for LGS Treatment

In March 2017, European Commission (EC) designated Zogenix, Inc.'s ZX008 (fenfluramine) as an orphan medicinal product for the treatment of LGS. In June 2017, FDA also granted ZX008 orphan drug designation for the treatment of LGS.

About Lennox-Gastaut Syndrome and Dravet Syndrome

Lennox-Gastaut syndrome (LGS), or childhood epileptic encephalopathy, is a pediatric epilepsy syndrome characterized by multiple seizure types, including mental retardation or regression, and abnormal findings on electroencephalography. Neurologic and neuropsychologic deficits inevitably appear during the evolution of LGS. The onset of LGS typically occurs between ages of three to five years.

Dravet syndrome, also known as severe myoclonic epilepsy of infancy, is a type of epilepsy with seizures that are often triggered by hot temperatures or fever. It is treated with anticonvulsant medications. It often begins around six months of age. Initial seizures are often body temperature related, severe, and long-lasting. Over time, patients with Dravet syndrome often develop multiple types of seizures, including tonic-clonic, myoclonic, and atypical absences. and are prone to bouts of prolonged seizures.

About Epidiolex® (cannabidiol)

Epidiolex® is GW Pharma's lead cannabinoid product candidate and is a proprietary oral solution of pure plant-derived cannabidiol. GW Pharma's Epidiolex® development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex, and Infantile Spasms.

About GW Pharmaceuticals PLC

Founded in 1998, GW Pharma 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 evaluates Epidiolex in additional epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. Headquartered in Cambridge, United Kingdom, GW Pharma also has operations in the United States.

Stock Performance Snapshot

December 29, 2018 - At Friday's closing bell, GW Pharma's stock dropped 2.18%, ending the trading session at $132.01.

Volume traded for the day: 262.70 thousand shares.

Stock performance in the last month – up 9.49%; previous three-month period – up 30.07%; past twelve-month period – up 18.47%; and year-to-date - up 18.13%

After last Friday's close, GW Pharma's market cap was at $3.42 billion.

The stock is part of the Healthcare sector, categorized under the Drug Manufacturers - Major industry.

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