Zogenix, a pharmaceutical company specializing in the treatment of chronic pain, and Astellas Pharma have announced positive clinical trial data from two studies of their needle-free migraine treatment system. Sumavel DosePro was approved by the U.S. Food and Drug Administration in July. It is the first needle-free drug delivery system of its kind for sumatriptan (marketed as Imitrex in tablet form), which has helped some patients obtain migraine relief within 10 minutes.
The first study found that Sumavel DosePro was rapidly absorbed, reaching peak concentration in the blood within 12 minutes. Sumavel DosePro was found to be as safe as a traditional needle-based system. The second study evaluated whether migraine patients could safely use Sumavel DosePro at home while experiencing a migraine headache. Ninety-eight percent of patients successfully used the system on their first try. The results of both clinical trials will be published in the November 2009 issue of the journal Headache.
Zogenix and Astellas expect to launch Sumavel DosePro in January. They have a large target market; nearly 30 million people in the U.S. suffer from migraine headaches.
There is a growing demand for needle-free drug delivery systems, which have the potential to increase compliance among needle-phobic patients. Companies working in this space include Bioject, ALARIS Medical, Crossject, Altea Therapeutics Corporation, and Antares Pharma.