According to OptiNose, it filed an investigational new drug (IND) application for an intranasal sumatriptan product with the US FDA in December, 2011, and the FDA has given OptiNose permission to proceed. The company now plans to begin Phase 3 trials in adults with acute migraine.
“This filing signals an important milestone in our quest to deliver improved relief to patients who suffer from migraine headaches. Based on our clinical study results to date, we are encouraged by the potential of the OptiNose technology and the significant impact it could have on patients with this debilitating condition,” commented OptiNose CEO Peter Miller.
The OptiNose delivery device uses bi-directional nasal technology that the company says can deliver drug to targeted areas of the nasal cavity while avoiding lung deposition. Delivery is activated by exhalation into a mouthpiece, which blows air and drug into the nose through a nozzle inserted in the patient’s nostril.
Read the OptiNose press release.
