Almirall SA, an international pharmaceutical company focused on innovation and a commitment to health, has started a second round of applications for regulatory approval for Sativex in Europe.
The list of countries requested the Health Authorities by GW Pharmaceuticals, under a Mutual Recognition Procedure (MRP), includes: Belgium, Finland, Ireland, Iceland, Luxembourg , Norway, the Netherlands , Poland, Portugal and Slovakia. The UK is acting as Reference Member State, as part of this MRP.
The response of health authorities is expected in first half of 2012 and then the approval process will continue in each country separately, according to local regulatory requirements.
“We welcome the opportunity to 'widen' accessibility geographically unique benefits of Sativex in relieving symptoms of spasticity in MS patients,” said Bertil Lindmark, chief scientific officer at Almirall.
Sativex offers a new treatment option for patients with symptoms of spasticity associated with MS who have previously not responded adequately to other anti-spasticity, and is currently available in Spain, Germany, Denmark, the United Kingdom, Canada and New Zealand. In addition, four more new countries should receive marketing approval this year: Sweden, Italy, Austria and the Czech Republic. Sativex is administered oromucosal spray (either on the inside of the cheek or under the tongue), which provides maximum efficiency of the active ingredients and better dosing flexibility, giving the opportunity for each patient manage the variable nature of spasticity.
Sativex, which was developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain. Almirall holds the rights to market the drug in Europe (except UK).
Sativex is an endocannabinoid system modulator indicated as first-class treatment to improve symptoms in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other drugs -spasticity and demonstrating a clinically significant improvement in symptoms related to spasticity during an initial treatment trial. The main active ingredient, delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), are extracted from specific chemotypes of Cannabis Sativa. Sativex is administered by mouth spray, providing maximum effectiveness of active ingredients and better dosing flexibility, making it possible for each patient to manage the variable nature of spasticity.
Sativex is manufactured through a series of controlled processes, resulting in a reproducible finished product manufactured according to good manufacturing standards. Each 100 microliter spray contains 2.7 mg THC and 2.5 mg CBD. The formulation also contains other cannabinoids, terpenoids and flavonoids of standardized doses, which contribute to the uniqueness of the drug. Sativex was developed by GW Pharmaceuticals plc, a company based in the UK.
Spasticity is a symptom defined by patients and caregivers as muscle spasms, stiffness, rigidity and / or walking difficulties, and is one of the most common symptoms of MS, occurring in 75 per cent of people suffering from this disease. Spasticity can affect many aspects of daily life of MS patients, and contributes greatly to the distress and disability.