A mouth spray containing cannabinoids reduces chronic pain and symptoms of muscle spasticity in patients with multiple sclerosis (MS), according to a new study by German researchers.
One month’s treatment with Sativex spray reduced MS spasticity by 20% or more in 4 out of 10 patients who were previously unresponsive to conventional therapies. After three months, there was a 30% improvement in symptoms. Three hundred patients with moderate to severe MS spasticity were enrolled in the study.
“An improvement on the numerical rating scale of at least 30% after 3 months is considered clinically relevant,” said lead investigator Peter Flachenecker, a professor at the Neurological Rehabilitation Centre Quellenhof in Bad Wildbad, Germany.
Flachenecker also noted that patients on Sativex were also able to sleep more soundly.
“It translates into less disturbed sleep due to MS spasms, less pain, improved bladder function and a greater ability to perform simple daily activities involving mobility,” said Flachenecker. “These findings from everyday clinical practice are aligned or superior to those reported in previous clinical trials with Sativex, and were achieved with slightly fewer average daily doses.”
After three months, the average dose was 6.7 sprays a day. The number of patients who needed physical therapy at home after three months fell by one third. Severe limitations in daily activities were reported by 25% fewer patients, and the number of patients reporting severe pain fell over 15%.
Sativex was generally well tolerated, with dizziness and drowsiness the most common side effects.
Sativex contains a formulation of cannabinoids, marijuana’s most active ingredients. It is sold throughout Europe, Canada and Mexico to treat cancer pain and MS related symptoms, but is currently not approved for sale in the United States. British-based GW Pharmaceuticals hopes to see FDA approval by the end of 2013.
Spasticity is one of the most common symptoms of MS, occurring in up to 75% of patients over the course of the disease. It is characterized by muscle spasms, stiffness and difficulty in moving muscles. Spasticity effects a patient’s ability to walk, move and sleep, and is considered one of the main factors contributing to their distress and disability.
Multiple sclerosis is a chronic disease which attacks the body’s central nervous system and destroys the myelin sheath that protects the nerve cells. An estimated 400,000 Americans have the disease and more than 2 million worldwide.
The results of the study were presented at the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Lyon, France.