Endo Pharmaceuticals has informed the Food and Drug Administration (FDA) of the discontinuation of Sumavel DosePro (sumatriptan injection), in the 4mg/0.5mL formulation.
However, the 6mg/0.5mL dose of Sumavel DosePro will remain available. The discontinuation of the 4mg/0.5mL formulation is described as a business decision and not related to quality, safety or efficacy concerns.
Sumavel DosePro is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. The therapeutic activity of sumatriptan is thought to be due to the agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.
For more information visit FDA.gov.