Zogenix, Inc. and Desitin Pharmaceuticals GmbH Announce Filing for European Regulatory Approval of SUMAVEL(TM) DosePro(TM) - European Pivotal Trial Confirms Bioequivalence
Published: Oct 28, 2009
SAN DIEGO and HAMBURG, Germany, Oct. 28 /PRNewswire/ -- Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, and Desitin Pharmaceuticals GmbH ("Desitin"), a privately held, mid-sized German pharmaceutical company, today announced that Desitin has filed for European regulatory approval of SUMAVEL DosePro (sumatriptan injection) needle-free delivery system. The announcement follows successful completion of a European pivotal bioequivalence trial comparing needle-free SUMAVEL DosePro to a traditional needle-based autoinjector, Imigran(R)-Inject, the European brand of Imitrex STATdose System(R). In March 2008, Zogenix and Desitin entered into a license agreement granting exclusive rights in the European Union to Desitin Pharmaceuticals GmbH ("Desitin") to develop and commercialize SUMAVEL DosePro.
"This filing demonstrates Desitin's ability to move this product candidate through development and into the European regulatory approval process," commented Dr. Martin Zentgraf, Desitin's General Manager. "Subject to regulatory approval, we look forward to launching it with our CNS-focused sales representatives and partner companies in the major European countries, bringing this important product candidate to the market for the benefit of patients."
Migraine is considered the most common neurological condition in the developed world. It is typically characterized by severe, recurring head pain, usually located on one side of the head and one or more of the following associated symptoms: nausea; vomiting; and increased sensitivity to light, sound and/or smell. Oral and nasal treatment options are available but often do not work quickly enough for patients who experience migraine episodes associated with sudden onset, waking, nausea or vomiting. While needle-based treatment options are associated with faster onset of relief, some patients are deterred from use due to needle-aversion and complicated delivery systems.
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.
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 sensitivity 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.
MOST COMMON ADVERSE REACTIONS
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.
About DosePro technology
The DosePro technology is an easy-to-use, pre-filled drug delivery system designed to enable self-administration of single doses of liquid drug formulations, subcutaneously, without a needle. The DosePro technology has undergone more than ten years of design, process engineering, clinical evaluation and development work. DosePro is protected by more than 80 patents, issued and applied for, worldwide. Approximately 9,000 injections have been delivered in clinical trials in volunteers using the DosePro needle-free drug delivery system.
Zogenix(TM), SUMAVEL(TM) and DosePro(TM) are trademarks of Zogenix, Inc.