Sativex, a Cannabis-derived medicine
Despite its pros and cons, with many users reporting greater benefits from cannabis flower, Sativex stands as a milestone in cannabis-based treatments for neurological diseases like multiple sclerosis. This medication, developed from marijuana plant extracts, provides a unique approach by harnessing THC and CBD cannabinoids in a balanced ratio. Its controlled formulation allows patients to experience effective relief from multiple sclerosis symptoms such as spasticity and pain, offering an accessible and scientifically supported treatment option.
Unlike other methods, Sativex allows for precise administration that minimises side effects while maximising therapeutic benefits. This provides a viable, regulated option for patients seeking a more standardised treatment to improve their quality of life or for those without access to other cannabis-based options. In this article, we will delve into the benefits of Sativex, its recommended usage, and its real-world impact on patients.
Sativex was authorised by health authorities in Spain
A Cannabis-derived medicine for the treatment of spasticity (muscle spasms, stiffness or difficulty moving) in people suffering from multiple sclerosis who are unable to control this symptom with their current medication, the manufacturer said in a statement.
Prior to commercialisation, Sativex requires pricing and reimbursement approval from the Spanish Ministry of Health, a process that is expected to be completed in the fourth quarter of 2010. Sativex, the first treatment for multiple sclerosis-associated spasticity in decades, has been developed by UK-based GW Pharmaceuticals and will be marketed in Europe (except the UK) by Almirall SA.
The drug is administered as a mouth spray solution (applied to the inside of the cheek or under the tongue) and has a flexible dosing regimen, which is particularly appropriate given the variability of both spasticity and multiple sclerosis itself from patient to patient.
In addition, GW Pharmaceuticals has initiated Mutual Recognition Procedure (MRP) registration procedures for the approval of Sativex in other EU member states, including major markets such as Germany, France and Italy.
The UK Medicines and Healthcare product Regulatory Agency (MHRA), which approved Sativex in June 2010, has agreed to act as the reference member state in this registration process.
Sativex cannabinoids
According to its manufacturer in Spain, Sativex is indicated as an adjunctive treatment for patients with moderate to severe spasticity secondary to multiple sclerosis, who have not responded to other available medicines and in whom a significant clinical improvement in spasticity-related symptoms is observed in a first trial.
Sativex contains active ingredients called ‘cannabinoids’, which are extracted from cannabis plants grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors found throughout the body, including in the brain. A receptor on neurons in the brain is a place where certain substances can bind for a period of time. When this happens, the binding has an effect on the cell and the nerve impulses it produces, leading to an improvement in the symptoms of spasticity. An estimated 40,000 people in Spain live with multiple sclerosis and spasticity is one of its most characteristic symptoms, occurring in up to 75% of these patients.
Spasticity can affect many aspects of multiple sclerosis patients’ daily lives and is one of the main factors contributing significantly to their sense of distress and disability.
The president of the Spanish Multiple Sclerosis (MS) Association, José Tomás Ruiz, has hailed the approval of Sativex in Spain as a major step forward, as the drug will restore some of the autonomy of many patients who are unable to control this symptom with current medication. Any step taken, no matter how small, is a big step, an abyss, because this is a disease whose origin is unknown, totally unpredictable and different in each patient, and whose sufferers are also discriminated against in terms of disability.
In his opinion, this news is not only positive because it will be of significant benefit to these patients and supports the therapeutic use of cannabis, but also because it raises the profile of this disease, which, he insists, is not really recognised as a disability and those affected are not entitled to the benefits to which they are entitled.
When a sclerosis sufferer’s disability is assessed,” he explains, “as the problems are not visible to the naked eye, only between 0 and 15% are recognised, never the 33% with which a disabled person can avail of any benefit, such as parking spaces or aid. We need that recognition.
MS is a chronic disease that affects the central nervous system, i.e. the brain and spinal cord. Although not everything is known about its origin, the most widely accepted theory is that genetic and environmental factors, such as viruses or vaccines, can trigger the disease in predisposed individuals.
Spasticity is a condition characterised by increased resistance of the muscle to an external stretch, usually with increased resistance to a sudden stretch. Spasticity in MS is due to changes in the central nervous system.
Effectiveness and Benefits of Sativex in Multiple Sclerosis
Sativex has proven to be a promising tool in the treatment of multiple sclerosis (MS) symptoms, particularly in the relief of muscle spasticity, which affects most MS patients. This medicine, made from THC and CBD extracts, offers a controlled and effective alternative that significantly reduces muscle spasms, pain and stiffness, allowing patients to improve their mobility and quality of life.
Clinical studies support its use, showing that Sativex, when prescribed and administered correctly, provides substantial and sustained relief from the symptoms associated with multiple sclerosis, without the significant psychoactive side effects associated with recreational cannabis use. It is important that patients have adequate medical support and monitoring to maximise the benefits of this treatment, adjusting the dosage as necessary to achieve the optimal therapeutic effect.
Impact on Patients’ Quality of Life
The use of Sativex has demonstrated a positive impact on the quality of life of patients with multiple sclerosis, enabling a reduction in symptoms such as spasticity and pain. For many patients, this translates into a significant improvement in their overall wellbeing and ability to perform everyday activities that were previously difficult due to their symptoms.
Beyond physical relief, access to a treatment such as Sativex also impacts on the mental health of patients, who report greater peace of mind and emotional stability as they experience fewer physical barriers and discomfort. The combination of positive physical and psychological effects reinforces the role that cannabinoid-based treatments can play in the therapeutic setting.
Sativex clinical trials for multiple sclerosis
Sativex, also known as Nabiximols, is a cannabis-based medicine approved in several countries to treat spasticity in patients with multiple sclerosis (MS). The formulation contains two main cannabinoids (THC and CBD) in a 1:1 ratio, which provide relief by modulating the endocannabinoid system. In recent years, clinical trials have demonstrated the efficacy and safety of the drug for MS-related spasticity, with positive results in patients who did not respond to other medications.
In a double-blind, placebo-controlled trial published in 2007 in the European Journal of Neurology, researchers found that Sativex significantly reduced spasticity in MS patients, allowing them to perform everyday tasks more comfortably. Patients who did not achieve adequate relief with other spasticity treatments demonstrated significant improvements during the study [source].
In addition, phase III trials have shown sustained benefits with Sativex. A recent study, led by Professor H.P. Hartung of the University of Düsseldorf, highlighted that Sativex not only improves spasticity, but also improves overall quality of life, showing a favourable tolerability profile with no noticeable withdrawal effects. This consistency in results has led to its regulatory approval in the UK, Spain and over 29 other countries for the treatment of multiple sclerosis [source].
Furthermore, the Sativex studies are in line with Almirall’s research initiative, which supports additional clinical trials to explore new therapeutic possibilities. The drug remains one of the few cannabis-derived treatments approved for MS, underscoring its unique role in neurology [source].
For more information on ongoing clinical trials and their results, visit ClinicalTrials.gov and search for “Sativex Multiple Sclerosis”.
Legality and Access to Treatment
Access to treatments such as Sativex and medical marijuana for multiple sclerosis varies significantly between countries. In Spain and other European countries, Sativex is approved for medical use on prescription, allowing patients to access safe and controlled treatment. However, the situation is different in regions of Latin America and other parts of the world, where laws on the use of medical cannabis are still developing.
The variability in legal regulations can represent a major barrier for those seeking to improve their quality of life through this type of treatment. In places where the use of medical marijuana or Sativex is not permitted, multiple sclerosis patients may have to turn to other alternatives, including outside the healthcare system. It is important to check local legislation and talk to healthcare professionals to learn about the legal and safe options available in each country.
Alternatives to Sativex and its Future in Medicine
Although Sativex has gained recognition as a pioneering treatment for multiple sclerosis, its cost and availability may limit access for some patients. Alternatives to Sativex include other prescription cannabinoids and preparations containing CBD and THC, in various concentrations and formats, which aim to provide similar symptomatic relief.
Progress in research and development of cannabis-based medicines promises to expand the therapeutic arsenal for the treatment of neurological conditions. New studies may lead to the creation of personalised treatments and improve the efficacy of Sativex, offering more access options and better quality of life for patients. Regulation and awareness of these treatments will continue to play a key role in their integration into modern medicine.
Many users prefer Cannabis Flower
The preference of many users for cannabis flower over Sativex is a recurring theme among medical and cannabis therapy users. Oral administration of Sativex results in slower absorption and lower blood levels of cannabinoids compared to inhalation, leading some users to not find the same immediate relief or intensity of effects as with flower [ source].
In addition, studies have indicated that Sativex administration tends to produce more stable levels of cannabinoids, but with less peak psychoactive effect, which may not be ideal for those who prefer the flexibility and rapid response of inhaled flower. The inhalation process allows the cannabinoids to bypass hepatic metabolism and enter the bloodstream quickly, providing more immediate relief that is valued by patients with chronic pain or episodes of severe spasms [source].
On the other hand, although Sativex complies with strict regulations, many users prefer cannabis flower due to the perception of naturalness and control over consumption, especially in countries where self-cultivation is legal. The controversy therefore lies in the fact that Sativex administration is designed to be measured and dosed, offering a more predictable experience without the risks associated with inhalation, but less adaptable to the individual needs of some users. Thus, the debate continues between those who value the efficacy of Sativex and those who find the flower a more versatile method of treatment [source].
Sativex is a cannabis-based medicine containing THC and CBD in balanced proportions. It is primarily used to treat spasticity in patients with multiple sclerosis and is administered via an oral spray. Its use is approved in several countries, but always under medical prescription.
The main difference lies in the form of administration and absorption. Sativex is an oral spray, allowing controlled release and prolonged effect, while the flower, when inhaled, is rapidly absorbed with an immediate effect, which many prefer for acute symptom relief.
Some patients find that inhaled cannabis flower offers more immediate and flexible symptom relief compared to Sativex. They also value the ability to adjust the dose to their individual needs, which is less flexible with the oral spray. This is due to the rapid absorption of cannabinoids through inhalation and the more direct effect.
Yes, Sativex has undergone rigorous safety and efficacy trials. However, like any medication, it can have side effects such as dizziness or fatigue. It should always be used under medical supervision, following the recommended dosage to avoid complications.
The most common side effects of Sativex include dizziness, drowsiness, and dry mouth. Some patients also report nausea or gastrointestinal discomfort. These effects are usually mild and disappear when the dose is adjusted, but it is important to monitor any adverse reaction.
Yes, Sativex is only available by prescription. This is because it contains active ingredients derived from cannabis, and its use must be monitored to ensure patient safety. It is not available without a prescription in pharmacies.
Some people choose to use cannabis flowers or CBD oils to manage symptoms, especially in countries where home cultivation is legal. However, these alternatives lack the same medical oversight and standardization as Sativex, which can lead to variations in effects and dosage.
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