Research & Development
XHANCE™ (fluticasone propionate)
We plan to initiate clinical trials of XHANCE in the second half of 2018 to seek a follow-on indication for the treatment of chronic sinusitis.
Central Nervous System (CNS) Diseases
We are exploring the possibility of using our Exhalation Delivery Systems (EDS) to support nose-to-brain drug delivery to treat such conditions as Prader-Willi syndrome, autism spectrum disorder, narcolepsy, and other diseases potentially amenable to the same pharmacologic activity, such as Parkinson’s disease. We intend to evaluate business development activities to capture value through the continued development of these assets.
By placing drugs high and deep in the nasal passages, 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.
We have engaged in early clinical development activities for OPN-300, which combines our 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 our EDS may allow for improved delivery.
OPN-300 is being developed to target 2 orphan indications: Prader-Willi syndrome, a rare genetic disorder that is the leading genetic cause of obesity; and autism spectrum disorder.
We are in preclinical development of OPN-021, which combines our EDS with orexin-A, also known as hypocretin-A, a peptide that acts as a neurotransmitter in the brain. OPN-021 is being developed for the treatment of narcolepsy or symptoms of other diseases potentially amenable to the same pharmacologic activity, such as Parkinson’s disease.
We are in the process of developing the formulation for OPN-021 and are planning to initiate a Phase I clinical trial when a suitable formulation is prepared.
We are evaluating the use of our EDS to deliver other drugs or drug combinations, including antibiotics, anticholinergics, antihistamines, mucolytics, leukotriene inhibitors, and other medication classes used to treat diseases primarily managed by ENT and allergy specialists. We have also identified several other product candidates with the potential to leverage our EDS to create clinically differentiated drug treatments for indications such as central nervous system disorders and pain.
We will continue to evaluate opportunities to develop product candidates indicated for markets outside of our ENT and allergy focus through business development activities.
*ONZETRA Xsail is licensed to Avanir Pharmaceuticals, Inc., an affiliate of Otsuka Pharmaceutical Co., Ltd.
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