Zogenix:FDA Oks SNDA For 4mg Dose Of Sumavel DosePro Needle-free Delivery System

(RTTNews) - Zogenix Inc. (ZGNX) announced Tuesday that the U.S. Food and Drug Administration or FDA has approved the supplemental New Drug Application or sNDA for a 4 mg dose of Sumavel DosePro (sumatriptan injection) Needle-free Delivery System.

The company noted that 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% of patients versus 4% for placebo). The product was launched in January 2010, reaching over 225,000 total prescriptions at the end of the third quarter 2013.

Sumavel DosePro is intended for use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with Sumavel DosePro, reconsider the diagnosis of migraine before Sumavel DosePro is administered to treat any subsequent attacks. Sumavel DosePro is not indicated for the prevention of migraine attacks, the company said.