Zogenix, Astellas Report Positive Clinical Results For New Needle-free Delivery System

Published: 22-Oct-2009

Sumavel DosePro, for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients

Zogenix and Astellas Pharma have reported positive results from two clinical studies of new Sumavel DosePro (sumatriptan injection) needle-free delivery system - Sumavel DosePro.

The new system was recently approved by the FDA to treat acute migraine, with or without aura, and cluster headache. It is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

Reportedly, the first clinical study evaluated the pharmacokinetics, bioequivalence and safety of administering subcutaneous sumatriptan via the new delivery system, as compared to a traditional needle-based autoinjector, Imitrex Statdose.

The study showed that it delivered subcutaneous sumatriptan in a manner bioequivalent to traditional needle-based technology when administered to the thigh and the abdomen, the most common sites of self-injection. The drug was absorbed rapidly, resulting in peak plasma concentrations within approximately 12 minutes.

The rate of absorption of subcutaneous sumatriptan has been previously shown to correlate with rapid and complete relief of migraine symptoms, including migraine relief within 10 minutes for some patients and almost 50% of patients within 30 minutes. Overall safety profiles were comparable for Sumavel DosePro and Imitrex Statdose.

However, the second study evaluated the ease-of-use of Sumavel DosePro in 52 patients who used the drug at home to treat their migraine headaches. The study assessed whether the patients, using instructions supplied, could correctly use Sumavel DosePro during their first use during a migraine episode.

In the study, 98% of the patients successfully used the new system during a migraine attack on their first attempt. The study also demonstrated a similarly high level of correct use over the remainder of the trial period (3 migraine attacks or 30 days, whichever occurred sooner).

Roger Hawley, director and CEO of Zogenix, said: "Until now, relatively fewer patients have benefited from the unique profile of subcutaneous sumatriptan as compared to the many patients who have taken triptan tablets. These data demonstrate that Sumavel DosePro is a unique new product which delivers subcutaneous sumatriptan in a way that will make physicians confident their patients will both get the full benefits of the medication and be able use it correctly.

"We believe Sumavel DosePro with its simple, needle-free delivery system will open the doors for many more patients to try and experience the benefits of rapid migraine relief from subcutaneous sumatriptan. We are excited to launch Sumavel DosePro with our co-promotion partner, Astellas, in January."

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