EPIDIOLEX®, the aboriginal FDA-approved decree biologic conception of awful purified, plant-derived cannabidiol (CBD), a cannabinoid defective the aerial associated with marijuana and the aboriginal in a new chic of anti-epileptic drugs. To apprentice more, appointment EPIDIOLEX.com
©2018 Greenwich Biosciences, Inc.
– Medication adumbrated for the analysis of seizures associated with Lennox-Gastaut affection or Dravet syndrome, two rare, astringent childhood-onset epilepsies –
– Absolute abutment affairs accessible for acceptable patients –
LONDON and CARLSBAD, Calif., Nov. 01, 2018 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), the apple baton in the development and commercialization of cannabinoid decree medicines, forth with its U.S. accessory Greenwich Biosciences, appear today that EPIDIOLEX® (cannabidiol) articulate band-aid CV is now accessible in the U.S. for the analysis of seizures associated with Lennox-Gastaut affection (LGS) or Dravet affection in patients two years of age or older. EPIDIOLEX, which was accustomed by the U.S. Food and Biologic Administration (FDA) on June 25, 2018, is the aboriginal decree biologic conception of awful purified, plant-derived cannabidiol (CBD), a cannabinoid defective the aerial associated with marijuana, and the aboriginal in a new chic of anti-epileptic drugs.
“We are captivated to advertise that EPIDIOLEX is now accessible by physician decree as a new analysis advantage for patients with LGS and Dravet syndrome, two of the best difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “Because these patients accept historically not responded able-bodied to accessible admission medications, there has been a acute charge for new therapies that aim to abate the abundance and appulse of seizures. We are committed to ensuring that these patients can admission this atypical cannabinoid anesthetic that has been thoroughly advised in analytic trials, bogus to assure affection and consistency, and is acceptable to be covered by allowance for adapted patients.”
The aggregation has alien a absolute accommodating abutment affairs alleged EPIDIOLEX Engage™, which is advised to advice patients who accept been assigned EPIDIOLEX accretion admission to therapy. The affairs offers patient/caregiver-focused apprenticeship and assets to advice lower abroad costs or accommodate artefact at no amount for acceptable patients. Added advice can be begin at EPIDIOLEX.com.
“EPIDIOLEX is a much-needed new analysis advantage for patients with LGS, a attenuate and astringent anatomy of childhood-onset attack that about persists into adulthood,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Affection Foundation. “Despite the use of assorted attack treatments, the majority of LGS patients abide to accept life-long, debilitating seizures and our association welcomes the availability of a new, first-in-class analysis option.”
“We are actual admiring that EPIDIOLEX — the aboriginal medication to be accustomed by the FDA for patients with Dravet affection — is now available,” said Mary Anne Meskis, Executive Director of the Dravet Affection Foundation. “Our association has continued adapted a medication accurately accustomed for the analysis of seizures associated with Dravet syndrome, and the availability of EPIDIOLEX is an important anniversary for patients and caregivers whose lives are decidedly impacted by this catastrophic, constant anatomy of epilepsy.”
The EPIDIOLEX analytic development affairs included three randomized, controlled Appearance 3 analytic trials and an open-label addendum study. The Appearance 3 studies accept been appear in The New England Journal of Medicine1, and Lancet3. EPIDIOLEX added to added antiepileptic therapies decidedly bargain the abundance of bead seizures in patients with LGS and convulsive seizures in patients with Dravet syndrome. The best accepted adverse reactions that occurred in EPIDIOLEX-treated patients were somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, beddy-bye ataxia and poor affection sleep; and infections. The company’s development affairs represents the alone well-controlled analytic development affairs of a cannabinoid medication arch to FDA approval for patients with LGS and Dravet syndrome.
EPIDIOLEX was developed by GW Pharmaceuticals and will be marketed in the U.S. by its subsidiary, Greenwich Biosciences. For added advice on EPIDIOLEX, appointment www.EPIDIOLEX.com.
About EPIDIOLEX® (cannabidiol) articulate solutionEPIDIOLEX, the aboriginal prescription, plant-derived cannabinoid anesthetic in the United States and the aboriginal in a new chic of anti-epileptic medications, is a biologic conception of awful antiseptic cannabidiol (CBD) now FDA accustomed for the analysis of seizures associated with Lennox-Gastaut affection (LGS) or Dravet affection in patients two years of age or older. GW has submitted a Marketing Authorization Appliance (MAA) to the European Medicines Agency (EMA) for EPIDIOLEX with an accepted accommodation date in the aboriginal division of 2019. GW has accustomed Orphan Biologic Designation from the FDA for EPIDIOLEX for the analysis of seizures associated with tuberous sclerosis circuitous (TSC). The Aggregation has additionally accustomed Orphan Designation from the EMA for EPIDIOLEX for the analysis of seizures associated with LGS, Dravet syndrome, and TSC. GW is currently administering an added Appearance 3 analytic development affairs in the analysis of seizures associated with TSC.
Important Assurance Advice & Indications What is the Best Important Advice I Should Apperceive About EPIDIOLEX?Do not booty if you are allergic to cannabidiol or any of the capacity in EPIDIOLEX.EPIDIOLEX may account alarmist problems. Your doctor may adjustment claret tests to analysis your alarmist afore you alpha demography EPIDIOLEX and during treatment. In some cases, EPIDIOLEX analysis may charge to be stopped. Alarm your doctor appropriate abroad if you alpha to accept any of these signs and affection of alarmist problems during analysis with EPIDIOLEX:
EPIDIOLEX may account you to feel sleepy, which may get bigger over time. Added medicines (e.g., clobazam) or booze may access sleepiness. Do not drive, accomplish abundant machinery, or do added alarming activities until you apperceive how EPIDIOLEX affects you.
Like added antiepileptic drugs, EPIDIOLEX may account baleful thoughts or accomplishments in a actual babyish cardinal of people, about 1 in 500. Alarm a healthcare provider appropriate abroad if you accept any signs of abasement or anxiety, thoughts about suicide or self-harm, animosity of agitation or restlessness, aggression, irritability, or added abnormal changes in behavior or mood, abnormally if they are new, worse, or anguish you.
Take EPIDIOLEX absolutely as your healthcare provider tells you. Do not stop demography EPIDIOLEX after aboriginal talking to your healthcare provider. Stopping a admission anesthetic aback can account austere problems.
What Else Should I Apperceive When Demography EPIDIOLEX?The best accepted ancillary furnishings of EPIDIOLEX accommodate sleepiness, decreased appetite, diarrhea, access in alarmist enzymes, activity actual annoyed and weak, rash, beddy-bye problems, and infections. EPIDIOLEX may affect the way added medicines work, and added medicines may affect how EPIDIOLEX works. Do not alpha or stop added medicines after talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including decree and over-the-counter medicines, vitamins, herbal supplements, and cannabis-based products.
EPIDIOLEX is a federally controlled actuality (CV) because it has a low abeyant for abuse. Keep EPIDIOLEX in a safe abode to anticipate theft, misuse, or abuse.
What Added Advice Applies to Women?If you are abundant or plan to become pregnant, EPIDIOLEX may abuse your approaching baby. You and your healthcare provider will accept to adjudge if you should booty EPIDIOLEX while you are pregnant.
If you become abundant while demography EPIDIOLEX, allocution to your healthcare provider about registering with the North American Antiepileptic Biologic Abundance Anthology (by calling 1-888-233-2334). The purpose of this anthology is to aggregate advice about the assurance of antiepileptic medicines during pregnancy.Because abounding medicines like EPIDIOLEX are anesthetized into milk, allocution to your healthcare provider about the best way to augment your babyish while demography EPIDIOLEX.
What is EPIDIOLEX?EPIDIOLEX is a decree anesthetic that is acclimated to amusement seizures associated with Lennox-Gastaut affection or Dravet affection in patients 2 years of age and older.
It is not accepted if EPIDIOLEX is safe and able in accouchement beneath 2 years of age.
Please accredit to the EPIDIOLEX Medication Guide and Instructions for Use for added important information.
You are encouraged to address ancillary furnishings of decree drugs to the FDA. Appointment www.fda.gov/medwatch, or alarm 1-800-FDA-1088. You may additionally acquaintance Greenwich Biosciences at 1‑833-424-6724 (1-833-GBIOSCI).
About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.Founded in 1998, GW is a biopharmaceutical aggregation focused on discovering, developing and commercializing atypical analysis from its proprietary cannabinoid artefact belvedere in a ample ambit of ache areas. GW, forth with its U.S. accessory Greenwich Biosciences, has accustomed U.S. FDA approval for EPIDIOLEX (cannabidiol) articulate band-aid for the analysis of seizures associated with Lennox-Gastaut affection (LGS) or Dravet affection in patients two years of age or older. The Aggregation has submitted a authoritative appliance in Europe for the accessory analysis of seizures associated with LGS and Dravet syndrome. The aggregation continues to appraise EPIDIOLEX in added attenuate attack altitude and currently has an advancing analytic balloon in tuberous sclerosis circuitous (TSC). GW commercialized the world’s aboriginal plant-derived cannabinoid decree drug, Sativex® (nabiximols), which is accustomed for the analysis of spasticity due to assorted sclerosis in abundant countries alfresco the United States and for which the aggregation is now planning a U.S. Appearance 3 trial. The Aggregation has a abysmal activity of added cannabinoid artefact candidates which includes compounds in Appearance 1 and 2 trials for epilepsy, glioblastoma, and schizophrenia. For added information, amuse appointment www.gwpharm.com.
Forward-looking statementsThis account absolution contains advanced statements that reflect GW’s accepted expectations apropos approaching events, including statements apropos banking performance, the timing of bartering barrage of EPIDIOLEX, the timing of analytic trials, the timing and outcomes of authoritative or bookish acreage decisions, the appliance of GW articles commercially accessible and in development, the analytic allowances of EPIDIOLEX (cannabidiol) articulate band-aid and the assurance contour and bartering abeyant of EPIDIOLEX. Advanced statements absorb risks and uncertainties. Actual contest could alter materially from those projected herein and depend on a cardinal of factors, including (inter alia), the success of GW’s analysis strategies, the account of the discoveries fabricated therein, the acknowledged and appropriate achievement and uncertainties accompanying to the authoritative process, and the accepting of Sativex, EPIDIOLEX and added articles by customer and medical professionals. An added account and description of risks and uncertainties associated with an advance in GW can be begin in GW’s filings with the U.S. Securities and Exchange Commission, including the best contempo Anatomy 20-F filed on 4 December 2017. Existing and -to-be investors are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date hereof. GW undertakes no obligation to amend or alter the advice independent in this columnist release, whether as a aftereffect of new information, approaching contest or affairs or otherwise.
1 Devinsky O, Cross JH, Laux L, et al. Balloon of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med 2017;376;2011-20.
2 Devinsky O, Patel AD, Cross JH, et al. Effect of Cannabidiol on Bead Seizures in the Lennox–Gastaut Syndrome. N Engl J Med 2018;378;20:1888-97.
3 Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut affection (GWPCARE4): a randomized, double-blind placebo-controlled appearance 3 trial. Lancet 2018;391;10125:1085-1096.
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