Research & Development
XHANCE® (fluticasone propionate)
We initiated a Phase 3b clinical trial program for XHANCE in the fourth quarter of 2018 to pursue a follow-on indication for the treatment of chronic sinusitis.
Other Product Candidates
Although our initial focus is to prioritize the successful commercialization and continued development of XHANCE for the ENT and allergy specialty segments, we have applied an Optinose EDS to other product candidates in our pipeline across a broad range of disease areas. By placing drug high and deep in the nose, in regions where cranial nerves connect directly with the brain, we believe it may be possible to deliver medications directly into the brain and avoid the difficulties of getting drug past the blood-brain barrier. This may enable treatment of brain diseases using small or large molecules that otherwise do not readily enter the nervous system.
We have engaged in early clinical development activities for OPN-300, which combines an Optinose EDS with oxytocin. Oxytocin is a small, naturally occurring peptide currently used to stimulate lactation in breastfeeding women. Oxytocin acts as a neurotransmitter in the brain and has recently been considered a potential novel treatment alternative in several brain disorders due to a growing body of evidence of its critical role in social cognition and behavior. Because oxytocin is a peptide with poor oral bioavailability, nasal administration with an Optinose EDS may allow for improved delivery. With standard liquid nasal spray delivery, only a small amount of the drug reaches systemic circulation. It is estimated that less than 0.01% of oxytocin in the blood enters the brain across the blood-brain barrier.
OPN-300 has been developed to target two orphan indications: Prader-Willi syndrome, a rare genetic disorder that is the leading genetic cause of obesity; and autism spectrum disorder. We conducted a Phase 1 clinical trial in late 2013 using OPN-300 in healthy volunteers. In that trial, a low dose of oxytocin delivered using an Optinose EDS produced a statistically significantly greater social-cognitive effect, as measured with functional
magnetic resonance imaging, performance on cognitive tests, and physiological markers, than intravenous administration of the same active ingredient that produced blood levels that were not statistically different. We believe this clinical trial supports the possibility of direct nose-to-brain activity of medication delivered using an Optinose EDS. In a second pilot clinical trial of OPN-300 in adult male patients with autism spectrum disorder, adult men with autism spectrum disorder receiving nasal oxytocin showed statistically significant differences in interpretation of facial expressions. We have completed planned internal development activities and, in the future, may pursue external partnerships for further development.
*Note: The Avanir License Agreement is expected to terminate on March 10, 2019. Optinose is evaluating options including seeking a new license partner.
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