Healthcare Industry News: dihydroergotamine
News Release - October 1, 2007
Valeant Pharmaceuticals to Partner with ASCEND Therapeutics to Promote Migranal(R) to OB/GYNsALISO VIEJO, Calif.--(HSMN NewsFeed)--Valeant Pharmaceuticals International (NYSE:VRX ) today announced that it has granted ASCEND Therapeutics exclusive rights to deploy ASCEND's 50-person specialty sales force to promote Valeant's Migranal® (dihydroergotamine mesylate, USP) Nasal Spray to more than 5,500 OB/GYNs in the United States. Valeant will continue to market Migranal to physicians outside the OB/GYN specialty area and retain all other responsibilities for the product.
"We are pleased to announce the promotion of Migranal to OB/GYNs with our partner ASCEND Therapeutics. Of the more than 65 million people worldwide who have experienced a migraine within the last 12 months, three-quarters of these patients are women. Migranal provides physicians with a valuable treatment option for patients with migraine headaches," said Wesley P. Wheeler, president, North America and Research and Development at Valeant.
"We are pleased to have the opportunity to promote a therapeutic option to treat a condition so common among women often in the early morning hours or during times of falling estrogen levels. Migranal provides significant value to women and to our women's health care franchise and will be integral as we continue to build and foster our specialty in the OB/GYN community," said Jay Bua, president of Ascend Therapeutics.
Valeant Pharmaceuticals International (NYSE:VRX ) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
ASCEND Therapeutics is a biopharmaceutical company focused on the use of transdermal drug delivery technology to overcome therapeutic barriers and raise the standard of care for certain chronic conditions. For more information about ASCEND, you may visit the company's web site at www.ascendtherapeutics.com.
About Migranal Nasal Spray
Migranal Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. Migranal Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.
Migranal is a registered trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or registered trademarks of their respective owners.
IMPORTANT SAFETY INFORMATION:
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.
Migranal Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm, including Prinzmetal's variant angina. Migranal also should not be given to patients with uncontrolled hypertension, patients who have used 5-HT1 agonists, ergotamine-containing or ergot-type medications or methysergide within the last 24 hours, or patients with hemiplegic or basilar migraine. Migranal Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function. Migranal Nasal Spray should not be administered to pregnant women or nursing mothers. Serious cardiac events, including some that have been fatal, have occurred following use of DHE 45 but are extremely rare. During clinical studies and the foreign postmarketing experience with Migranal Nasal Spray, there have been no fatalities due to cardiac events.
The most commonly reported adverse events in clinical trials for Migranal Nasal Spray were rhinitis, altered sense of taste, application site reactions, dizziness, nausea and vomiting. Adverse events associated with discontinuation were rhinitis, dizziness, facial edema, cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paresthesia.
For complete Prescribing Information, including BOXED Warning please visit www.migranal.com.
Source: Valeant Pharmaceuticals
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