GW Pharmaceuticals plc, the world leader in discovering, developing and commercializing cannabinoid prescription medicines. Announces that two of its medicines, EPIDYOLEX (cannabidiol) oral solution and Sativex (nabiximols), have been recommended by the UK's National Institute for Health and Care Excellence (NICE) to receive routine reimbursement from National Health Service(NHS) England.
Cannabidiol oral solution and nabiximols are the first and only plant-derived cannabis-based medicines to be routinely reimbursed on the NHS.
New guidance from the National Institute for Health and Care Excellence (Nice) has led to the recommendation of Epidyolex for rare types of epilepsy, Lennox-Gastaut and Dravet syndromes, and the spray Sativex for muscle spasms in multiple sclerosis.
When added to other anti-epileptic therapies, GW's cannabidiol oral solution significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome. The most common adverse reactions that occurred in patients treated with the medicine were somnolence, decreased appetite, diarrhea, pyrexia, fatigue, and vomiting. GW's development program represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with refractory epilepsy.
GW's cannabidiol oral solution was approved by the EMA and received marketing authorization in September 2019 under the trade name EPIDYOLEX as adjunctive therapy for seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. Following this approval, GW has been working with the relevant bodies in the UK, Germany, Spain, France, and Italy to secure reimbursement ahead of the anticipated launch of the medicine in these countries.
The inclusion of nabiximols in NICE guidelines comes as part of the comprehensive evaluation of the clinical and cost-effectiveness of CBMPs. Nabiximols has been approved by medicines regulators in more than 25 countries around the world.
Nabiximols was approved in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2010 and is marketed in the UK by GW's commercial partner, Bayer.
Doctors will be able to prescribe Epidyolex, for children with two types of severe epilepsy - Lennox Gastaut syndrome and Dravet syndrome - which can cause multiple seizures a day.
Clinical trials have shown the oral solution, which contains cannabidiol (CBD), could reduce the number of seizures by up to 40% in some children.
About EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution
EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the FDA for use in the U.S., is an oral solution which contains highly purified cannabidiol (CBD). The medicine is for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older and is the first in a new class of anti-epileptic medications with a novel mechanism of action.
EPIDYOLEX received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2019 and the European Commission (EC) granted the marketing authorization on 23 September 2019 for adjunctive use in conjunction with clobazam. The medicine was granted an Orphan Drug Designation from the EMA for the treatment of seizures associated with LGS, Dravet syndrome, and Tuberous Sclerosis Complex (TSC).
About Sativex® (nabiximols)
Sativex® (nabiximols), the first cannabinoid medicine derived from the cannabis plant, is an oromucosal spray which contains a complex mixture of cannabinoids, including delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and specific minor cannabinoids and other non-cannabinoid components.
Nabiximols is approved in over 25 countries around the world for the treatment of spasticity due to multiple sclerosis (MS) in people 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.
Nabiximols is currently licensed to Almirall in Europe (excluding the UK), to Bayer in the UK and Canada, Neopharm in Israel, IDS Medical in UAE, Al-Mojil in Kuwait, Ipsen in Latin America (excluding Mexico and Islands of Caribbean), and Emerge Healthcare in New Zealand and Australia.
About Dravet syndrome
Dravet syndrome is a severe infantile-onset and highly treatment-resistant epileptic encephalopathy frequently associated with genetic mutations in the sodium channel gene SCN1A. It has early-onset, multiple types of seizures, high frequency of seizures, serious mental damage, and poor drug treatment.
The onset of Dravet syndrome typically occurs during the first year of life in previously healthy and developmentally normal infants. 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 including status epilepticus, which can be life-threatening.
The risk of premature death including SUDEP (sudden unexpected death in epilepsy) is elevated in patients with Dravet syndrome. Additionally, the majority of patients will develop moderate to severe intellectual and developmental disabilities and require lifelong supervision and care.
About Lennox-Gastaut syndrome (LGS)
LGS is an age-related cryptogenic or symptomatic systemic epilepsy syndrome, a type of age-dependent epilepsy encephalopathy. It is characterized by early onset of onset, onset in early childhood, and various forms of seizures. Mental development is affected and treatment is difficult. It is a serious type of epilepsy.
It can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and genetic neuro-degenerative or metabolic conditions.
Patients with LGS commonly have multiple seizure types including drop and convulsive seizures, which frequently lead to falls and injuries, and non-convulsive seizures.
Resistance to anti-epileptic drugs (AEDs) is common in patients with LGS. Most patients with LGS experience some degree of intellectual impairment, as well as developmental delays and aberrant behaviors.
Multiple Sclerosis (MS)
Multiple sclerosis (MS) is a chronic neurological condition characterized by progressive and disabling loss of motor and sensory nervous system functions. It is the most common type of central nervous system demyelinating disease. Demyelination is a type of injury in which myelin, which is important for neurotransmission, is damaged. Common symptoms are muscle sclerosis, chronic pain, motor paralysis, sensory disturbances, dysuria, visual impairment, language barriers, etc.
In Europe, the prevalence rate of MS is estimated to be 83 per 100,000 and is most commonly diagnosed between the ages of 20 and 40, although it can affect younger and older people too. In the UK, it affects around 100,000 people. Spasticity related to MS is an involuntary increase in muscle tone affecting more than 80% of MS patients across their disease evolution, and being moderate or severe in one-third of them despite physiotherapy and first-line drug treatments.
The burden of spasticity grows as the MS evolves. When the muscle is moved externally, there is more resistance to this movement than there normally would be and the muscle feels stiff or rigid. Increased muscle tone also means that muscles are slow to relax, and this causes stiffness. Spasticity, beyond the continuous stiffness, may also cause muscles to jerk suddenly in an uncontrolled way.
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