|Mallinckrodt and Zogenix Announce Exclusive Co-Promotion Arrangement on SUMAVEL® DosePro®|
Collaboration agreement between
Under terms of the agreement, Mallinckrodt’s U.S. sales force will sell
SUMAVEL DosePro to its customer base of prescribers.
"This agreement represents a key component of our growing
pharmaceuticals business as we prepare to spin off from
“We are leaders in pain management,” Mr. Trudeau said. “This opportunity
allows us to help patients who suffer from migraine manage its
often-debilitating impact, as well as to build out our existing pain
management franchise. We look forward to working with
Covidien’s Pharmaceuticals business is the largest U.S. supplier of
opioid pain medications and among the top 10 generic pharmaceuticals
manufacturers in the U.S., based on prescriptions. Its branded portfolio
includes EXALGO® (hydromorphone HCl) Extended-Release Tablets
(CII) and PENNSAID® (diclofenac sodium topical solution) 1.5%
“Adding Mallinckrodt’s large sales force to the efforts of our 95 sales
representatives will double our reach into prescribers of migraine
products and significantly expand the sales coverage for SUMAVEL DosePro
within the primary care market,” said
SUMAVEL DosePro is the first and only needle-free delivery system for
subcutaneous sumatriptan for the treatment of acute migraine and cluster
headache. In clinical studies1, sumatriptan injection
provided migraine relief within 10 minutes for 16% of patients versus 4%
for placebo. The product was launched in
1 Cady RK, Wendt JK, Kirchner JR, Sargent JD, Rothrock JF, Skaggs Jr., H. Treatment of Acute Migraine with Subcutaneous Sumatriptan. JAMA 1991; 265:2831-2835.
About SUMAVEL DosePro
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.
SUMAVEL DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. SUMAVEL DosePro 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.
IMPORTANT SAFETY INFORMATION
SUMAVEL DosePro is contraindicated in patients with uncontrolled hypertension, in patients with history, symptoms or signs of ischemic heart disease, coronary artery vasospasm, cerebrovascular or peripheral vascular disease including ischemic bowel disease and in patients with other significant underlying cardiovascular diseases or known hypersensitivity to sumatriptan. SUMAVEL DosePro 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.
Do not use SUMAVEL DosePro and any ergotamine-containing or ergot-type medication within 24 hours of each other; do not use SUMAVEL DosePro and another 5-HT1 agonist (e.g. triptan) within 24 hours of each other (with the exception of a single dose of another sumatriptan product, provided the doses are separated by at least 1 hour). SUMAVEL DosePro 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.
For full prescribing information, please click here: http://www.zogenix.com/downloads/SV0468.0611_SDP_PI.pdf
For more information about SUMAVEL DosePro, please visit www.SUMAVELDosePro.com.
• Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
• PENNSAID is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery.
• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT
SELECTION AND LIMITATIONS OF USE
Potential for Abuse
EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
Proper Patient Selection
EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.
EXALGO is for use in opioid tolerant patients only.
Fatal respiratory depression could occur in patients who are not opioid tolerant.
Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone.
Limitations of Use
EXALGO is not indicated for the management of acute or postoperative pain.
EXALGO is not intended for use as an as-needed analgesic.
EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone.
EXALGO is a registered trademark of
SUMAVEL and DosePro are registered trademarks of