Zogenix, Inc., a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders and pain, has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for a 4 mg dose of Sumavel DosePro (sumatriptan injection) Needle-free Delivery System. Sumavel DosePro has been available in a 6 mg dose for the treatment of acute migraine and cluster headache.
The 4 mg dose of Sumavel DosePro can be used to help migraine sufferers who require management of side effects. The 4 mg dose of Sumavel DosePro is expected to be available approximately June 2014.
Sumavel DosePro is the first and only needle-free delivery system for subcutaneous sumatriptan for the treatment of acute migraine and cluster headache. Clinical data has shown that the current 6 mg dose of Sumavel DosePro can provide migraine pain relief within 10 minutes for some patients (16 per cent of patients versus four per cent for placebo). The product was launched in January 2010, reaching over 225,000 total prescriptions at the end of the third quarter 2013.
"Having a lower dose option of Sumavel DosePro will allow physicians to use another tool in the management of migraine and cluster headache," said Roger K Cady, MD, director of the Headache Care Center in Springfield, Mo. Cady continued, "The well-established efficacy of sumatriptan injection with the benefit of increasing patient satisfaction using needle-free technology, supports the goal of optimizing migraine treatment."
Roger L Hawley, chief executive officer of Zogenix, said, "We are pleased to be able to provide treatment solutions to help patients better manage their migraine and cluster headache attacks. We continue to improve our product and educational resources based on the feedback we receive from headache specialists who are experts in the treatment of migraine."
According to the National Headache Foundation, acute migraine attacks affect nearly 30 million Americans, primarily women between the ages of 25 and 40, who are treated by primary care physicians, neurologists and headache specialists. Tablets are a treatment option for some of these migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed, particularly for those who experience migraine attacks associated with sudden onset, waking, nausea or vomiting. The US Headache Consortium endorses migraine treatment guidelines which support a "toolbox" approach to providing treatment options for improved outcomes.