Under the terms of the agreement, OptiNose received $20m in upfront cash and is eligible to receive up to an additional $90m based on future clinical, regulatory and commercial milestones. If approved, Avanir will make tiered royalty payments based on net sales in North America.
The greatest advantage of the intranasal device, which was first developed by a Norwegian ENT, is the onset of the sumatriptan, Peter Miller, CEO of OptiNose, told in-Pharmatechnologist.com. In comparative PK studies, OptiNose found there was about three times as much drug in the blood of patients who used the device when compared to those who took the oral pill, he said.
The results of the company’s Phase III study, unveiled last year, also found that the device provided headache relief for 68% of patients with moderate to severe migraines after two hours, while nearly 42% reported pain relief at 30 minutes after treatment.
OptiNose's technology is unique in that it propels medications deep into the nasal cavity with the user’s breath. As a user exhales into the device, it automatically closes the soft palate and seals off the nasal cavity completely. The exhaled breath then carries medication from the device into one side of the nose through a sealing nosepiece (see the YouTube video for a visual).
Other formulations of the commonly used migraine treatment sumatriptan include a transdermal patch from NuPathe, known as Zecuity, which was approved by the US FDA in January.
Miller said both the transdermal patch and the OptiNose device have the advantage of working for patients prone to nausea or vomiting, though the intranasal delivery offers a faster onset than the patch, he said.
Other Potential Nasal Technologies
OptiNose is looking to develop the system for use with a nasal polyposis treatment, and possibly for other uses, including with oxytocin as a mood enhancer for patients with autism, Miller added.
Vaccine makers may also look to develop intranasal systems moving forward, he said, noting the advantage of delivering treatments directly from deep in the nose into the brain as it can circumvent the blood-brain barrier.
Other companies are looking to nasal technologies for more common uses. St. Renatus is developing a nasal mist that would deliver a dental anesthetic to replace the more frequently used injection when patients have to undergo hard tissue procedures, such as fillings. Adult Phase III trials are expected to finish later this summer.
Makers of biologics are also continually looking at nasal delivery tech to increase patient compliance.