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Zogenix Begins Promotion Of Migranal(R) Nasal Spray

SAN DIEGO, Aug. 1, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today that its sales force has initiated promotion of Migranal ® (dihydroergotamine mesylate, USP) Nasal Spray in the United States under the company's exclusive co-promotion agreement with Valeant Pharmaceuticals North America LLC.

Roger L. Hawley, chief executive officer of Zogenix, stated, "Since entering into our co-promotion agreement with Valeant at the end of June, we have worked closely with their team to rapidly train our sales force to promote Migranal, a number of whom previously promoted the product before joining Zogenix. We are pleased to now be providing Migranal alongside SUMAVEL DosePro, as part of a toolbox of treatment options for migraine sufferers. This also allows us to very efficiently leverage our sales force and expertise in migraine with our key customers. As we continue to position our commercial operations to reach profitability, we will evaluate additional opportunities to add innovative, complementary migraine therapies to our product portfolio to further leverage our experienced sales force and customer focus."

The U.S. Headache Consortium's migraine treatment guidelines encourage the use of a toolbox of treatment options to address the variety in migraine attacks. Having Sumavel DosePro and Migranal on hand to treat specific attacks is consistent with that approach, although the two products should not be used within 24 hours of each other. Migranal Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. Zogenix's commercialized migraine product, SUMAVEL® DosePro® Needle-free Delivery System (sumatriptan injection), is indicated for the acute treatment of migraine attacks, with or without aura, and cluster headache.

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), 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 (e.g., sumatriptan), 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.

Migranal ® Nasal Spray should only be used where a clear diagnosis of migraine headache has been established.

Serious cardiac events, including some that have been fatal, have occurred following use of DHE (dihydroergotamine) 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.

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