OptiNose has announced results of a randomized, single-dose, four-way cross-over PK study demonstrating that 20% less of its intranasal dry powder sumatriptan product delivered into the nose than Imitrex nasal spray resulted in over 60% more sumatriptan in the blood in the first 15 minutes. The 16 mg dose of the Optinose product also resulted in over 30% more in sumatriptan in the blood in the first 15 minutes than did a 100 mg oral dose. The dry powder formulation is delivered by OptiNose’s novel bi-directional intranasal delivery device.
Optinose COO Ramy A. Mahmoud commented, “Migraines affect nearly 30 million Americans. People often experience symptoms that progress rapidly, making it difficult to initiate or complete daily activities. Even with the wide range of current medications, many migraine sufferers are dissatisfied and searching for new treatments that provide faster relief with fewer side effects. These data show the OptiNose technology has the capability of more efficiently and effectively delivering medicine into the blood in the important first 15 to 30 minutes. Now that OptiNose has demonstrated better drug delivery, we are working on the clinical program to show how improved drug delivery translates into meaningful benefits for migraine sufferers.”
According to the company, it is enrolling patients in the Phase 3 COMPASS study to determine whether the OptiNose nasal sumatriptan powder relieves headaches more quickly than sumatriptan tablets.
Read the Optinose press release.