Research & Development
XHANCE® (fluticasone propionate) nasal spray with an Exhalation Delivery System
We initiated a Phase 3b clinical trial program for XHANCE in the fourth quarter of 2018 to pursue a new indication for the treatment of chronic sinusitis (CS). There are no drug treatments currently approved for the treatment of Chronic Sinusitis, and we believe XHANCE has potential to be the first drug therapy approved by the FDA for the treatment of CS.
Other Drug-Device Product Candidates Combining Drug with Exhalation Delivery Systems
Although our current focus is to prioritize the successful commercialization of XHANCE for the ENT and allergy specialty segment and the continued development of XHANCE for chronic sinusitis, we may apply or out-license our Exhalation Delivery System (EDS) technology to other product candidates across a broad range of disease areas. For example, 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. Other potential examples where deep and broad intranasal delivery may create differentiated clinical benefits include delivery of vaccines to antigen-presenting immune cells throughout the upper respiratory tract to boost humoral (IgG), mucosal (IgA), and cell-mediated immune responses, rapid introduction of drugs to the blood to enhance speed of onset, and treatment of local conditions related to the nose and related structures (e.g., the olfactory cleft, trigeminal ganglion, etc.).
In June 2020, we announced the initiation of development of a new product candidate, OPN-019, which combines our proprietary intranasal EDS with an antiseptic. In vitro testing of our candidate formulation has demonstrated ≥4 log kill for the SARS-CoV-2 virus and other pathogens. A pilot single-dose human study in patients with COVID-19 to evaluate reduction in viral load is planned. We intend to seek grants, partnerships, and/or other sources of capital to fund future development of OPN-019.
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