Dr. Reddy's Laboratories on Tuesday said its migraine injection ZembraceSym Touch is now commercially available in the U.S. market after receiving nod from the U.S. Food and Drug Administration (USFDA) in January 2016.
The pharma major said ZembraceSym Touch would be available in the U.S. markets through its wholly owned subsidiary Promius Pharma LLC.
ZembraceSym Touch is a pre-filled, single-dose disposable injector, which leads to rapid relief of migraine, Dr. Reddy's said in regulatory filing to the Bombay Stock Exchange (BSE).
People who suffer from migraine usually have more than one kind of attacks for which they need different kinds of medications.
"ZembraceSym Touch is a welcome addition to the toolkit for acute treatment of migraine. This 3 –mg, easy to- use subcutaneous injection of sumatriptan may be desired by many patients who need a medication that can rapidly treat migraine attacks," Roger Cady, executive chairman of National Headache Foundation, said.
He added that 3-mg doses allow for upto four dose in a 24- hour period, thus allowing doses flexibility for patients. ZembraceSym Touch is available as a box of four auto injectors.
The injection has also been proven to be safe and effective for use in children less than 18 years of age. The injection does not prevent or decrease the number of migraines.
Its use has been prohibited in people prone to risk factors for heart diseases, high cholesterol levels, smoking, diabetes and obesity.
The World Health Organization estimates that 30 percent of the adults in the age-group of 18-65 years reported migraines. The side-effects associated with the oral treatment of migraines including nausea, vomiting and gastric disturbances makes them potential candidates for treatment with injectables.
