Dr Reddy’s Laboratories has received the US Food and Drug Administration (USFDA) nod for ZembraceSymTouch (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine in adults. The product is available as a pre-filled, ready-to-use, single-dose disposable auto-injector containing 3 mg of sumatriptan. The injection is intended to be given subcutaneously .
This is the first branded product in the company’s neurology portfolio. It will be marketed in the United States by Promius Pharma, a wholly-owned specialty company of Dr Reddy’s Laboratories.
What is Migraine?
- Migraine is a neurological disease characterized by recurrent moderate to severe headaches often in association with a number of autonomic nervous system symptoms.
- Migraines are believed to be due to a mixture of environmental and genetic factors. About two-thirds of cases run in families
- Globally, approximately 15% of the population is affected by migraines at some point in life. It is more common in women at 19% than men at 11%
- People with migraines, particularly women, may develop higher than average numbers of white matter brain lesions of unclear significance.