New drug to treat restless legs
Sat, 09 Apr 2011 09:36:10 GMT
The Food and Drug administration (FDA) has approved gabapentin as a new medication for treatment of nightly disturbing condition called restless leg syndrome (RLS).
The US Federal agency came to its new decision after two 12-week clinical trials showed that the drug considerably relieves the symptoms of restless legs syndrome in comparison to placebo.
Restless leg syndrome, an annoying nighttime condition is a neurological disorder characterized by nighttime irresistible urge to move one's legs.
About a year ago, the FDA denied the approval horizant, a generic form of the drug produced by two pharmaceutical companies XenoPort Inc. and GlaxoSmithKline PLC.
At that time, the agency indicated that a preclinical finding of a sort of pancreatic tumor in rats was of sufficient concern to preclude approval of Horizant for RLS.
However, after reviewing additional preclinical data on the drug's safety, the FDA on its latest decision showed a green light to the use of a single daily dose of horizant for the treatment of moderate-to-severe primary restless legs syndrome.
Horizant is an extended release drug, designed to be absorbed slowly throughout the night so that it has a longer duration of activeness. It was designed to be absorbed this way because restless legs syndrome symptoms tend to be worse in the evening hours.
However, the FDA has advised people who sleep during the day and are awake at night not to take against taking the medication.
About 10 percent of people in the US are suffering from RLS, while 2 percent to 3 percent of the population have moderate to severe versions of the syndrome.
Gabapentin is the third drug the FDA has approved to treat restless legs syndrome, and the first one that is going to be used for moderate to severe form of the condition.