The review has been completed and the FDA has notified the company to proceed with the studies related to IND.
The company is expected to initiate Phase III trials in adults with acute migraine with or without aura utilizing its novel intranasal technology.
OptiNose CEO Peter Miller said the filing signals an important milestone in their 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," Miller added.