Zogenix, Inc. a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, confirmed that a recently issued patent (US patent number 7,776,007) which covers the company's branded migraine treatment, Sumavel DosePro (sumatriptan injection) Needle-free Delivery System, has been listed in the United States Food and Drug Administration (FDA) Orange Book.
The listed patent describes essential elements of the DosePro technology that enable a patient to prepare the product for administration in a few simple steps. This patent is not expected to expire until 2025, eight years after any of the previous listed patents for Sumavel DosePro.
Zogenix launched Sumavel DosePro in the United States in January 2010, for the acute treatment of migraine and cluster headache with its co-promotion partner Astellas Pharma US, Inc. Sumavel DosePro offers fast-acting, easy-to-use, needle-free subcutaneous administration of sumatriptan in a pre-filled, single-use delivery system. The combination of these unique product attributes allows physicians to prescribe Sumavel DosePro to address important unmet needs of many migraine sufferers.
The FDA's Approved Drug Products List with Therapeutic Equivalence Evaluations commonly referred to as the Orange Book, lists all drug products that have been approved by the FDA for safety and effectiveness. The Orange Book also includes information on patents which claim an approved drug product or method of use of the drug product, to facilitate the legal requirement that generic drug applicants include an appropriate certification to each such patent as part of any Abbreviated New Drug Application (ANDA) for a generic version of a listed drug.
Sumavel DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes. It should only be used where a clear diagnosis of migraine or cluster headache has been established and is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of Sumavel DosePro, the diagnosis of migraine or cluster headache should be reconsidered before administration of a second dose.
Sumavel DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebro-vascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. It should not be given to patients in whom unrecognized coronary artery disease is predicted by the presence of risk factors without a prior cardiovascular evaluation.
Serious cardiovascular events, including death, have been reported when taking sumatriptan, including patients with no findings of cardiovascular disease. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Cerebrovascular events, some fatal, have been reported in patients treated with sumatriptan. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. It is important to advise patients not to administer Sumavel DosePro if a headache being experienced is atypical.
Sumavel DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and is not generally recommended for use with MAO-A inhibitors. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including treatment with Sumavel DosePro, particularly during combined use with Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs). Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation and headache.
Zogenix, Inc. first commercial product, Sumavel DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache.