Strides Arcolab Limited has received the US Food and Drug Administration (US FDA) approval for sumatriptan succinate injection 6 mg (base)/0.5 mL. The drug is a selective agonist for a vascular 5-hydroxytryptamine1 receptor subtype. It is used for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes.
Sumatriptan will be offered as 6 mg (base)/0.5 mL, packaged in single-use prefilled syringes. The company stated that the vascular 5-HT1 receptor subtype to which Sumatriptan binds selectively and exerts its antimigrainous effect is present on cranial arteries, on the human basilar artery and in the vasculature of the isolated dura mater of humans. In these tissues Sumatriptan activates this receptor to cause vasoconstriction, an action correlating with the relief of migraine and cluster headache. The injection should not be given to patients with history, symptoms or signs of ischemic cardiac, cerebrovascular, peripheral vascular syndromes or with other significant underlying cardiovascular diseases, Besides it should not be given intravenously because of its potential to cause coronary vasospasm.
According to IMS data, the total US market for sumatriptan in 2009 was around $ 200 million, of which the market for auto-injectors using pre-filled syringes and cartridges is approximately $182 million.
However, the company was not in a position to provide details about the exact launch of the product, but stated that sumatriptan will be introduced under the partnership between Strides and Sagent Pharmaceuticals wherein the former is s developing and supplying more than 25 injectable products for the US market marketed by Sagent .
Bangalore-based Strides Arcolab, develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.
The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.
The four-year-old Sagent Pharmaceuticals, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products. currently it has more than 200 products under development.