Zogenix Closes Sale of SUMAVEL(R) DosePro(R) Migraine Therapy to Endo International
The SUMAVEL DosePro New Drug Application has been transferred to
In conjunction with the closing of the sale,
About SUMAVEL DosePro
INDICATION and IMPORTANT LIMITATIONS
Sumavel DosePro (sumatriptan injection) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and the acute treatment of cluster headache in adults.
Limitations of Use
SUMAVEL DosePro is intended for use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with SUMAVEL DosePro, reconsider the diagnosis of migraine before SUMAVEL DosePro is administered to treat any subsequent attacks. SUMAVEL DosePro is not indicated for the prevention of migraine attacks.
Dosage and Administration
The maximum single recommended dose of Sumavel DosePro for the acute treatment of migraine or cluster headache is 6 mg given subcutaneously. SUMAVEL DosePro is intended for subcutaneous use only. SUMAVEL DosePro is intended for use as an acute treatment of migraine or an acute treatment of cluster headache. For the treatment of cluster headache, the efficacy of a lower dose has not been established. The maximum cumulative dose of SUMAVEL DosePro in a 24-hour period is 12 mg, with doses separated by at least 1 hour. SUMAVEL DosePro is intended to be administered only to the abdomen or thigh.
IMPORTANT SAFETY INFORMATION
SUMAVEL DosePro is contraindicated in patients with ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina; Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; history of stroke or transient ischemic attack (TIA); hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication; current or recent (past 2 weeks) use of monoamine oxidase-A inhibitor; and known hypersensitivity to sumatriptan.
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of SUMAVEL DosePro. Some of these reactions occurred in patients with no known CAD. SUMAVEL DosePro may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD. 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.
Warnings and Precautions
Discontinue use of SUMAVEL DosePro if the following occur: arrhythmias; cerebral hemorrhage, subarachnoid hemorrhage, and stroke; gastrointestinal ischemia and infarction events, peripheral vasospastic reactions; serotonin syndrome; and/or anaphylactic/anaphylactoid reactions. Perform cardiac evaluation in patients with multiple cardiovascular risk factors, including myocardial ischemia/infarction and Prinzmetal's angina. While generally not associated with myocardial ischemia; evaluate for CAD in patients at high risk with the following symptoms: chest/throat/neck/jaw pain, tightness, pressure, or heaviness. In the event of a headache associated with medication overuse, detoxification may be necessary. In the event of an increase in blood pressure, monitor blood pressure. Use with caution in patients with epilepsy or a lowered seizure threshold.
In controlled clinical trials with sumatriptan injection, the most common adverse reactions were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.
For full prescribing information, please click here: http://www.zogenix.com/downloads/SV0468.1113_SDP_PI.pdf
For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.
SUMAVEL® DosePro® is a registered trademark of
Zack Kubow, The Ruth Group646.536.7020, email@example.com Media Aaron Estrada, The Ruth Group646.536.7028, firstname.lastname@example.org