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Optinose intends to use the net proceeds of the offering for working capital and general corporate purposes, including the commercialization of XHANCE, and the pursuit of a follow-on indication for XHANCE for the treatment of chronic sinusitis.
XHANCE® (fluticasone propionate) nasal spray is a drug-device combination product combining its proprietary Exhalation Delivery System designed to uniquely deliver drug high and deep in nasal passages with an anti-inflammatory drug.
The safety profile and tolerability of Fluticasone Propionate in this trial were consistent with its currently labelled safety profile. Adverse events occurring at a rate of more than 3% with XHANCE and common than the Exhalation Delivery System placebo group in this trial.
Medtronic has acquired Intersect ENT's PROPEL™ and SINUVA™ (mometasone furoate) sinus implant product lines and technology, intellectual property, and Menlo Park, Calif., facility.
The approval marks the first branded Rx-to-OTC switch for the company and paves the way for Nasonex® 24HR Allergy (mometasone furoate monohydrate 50mcg) to enter the OTC marketplace.
XHANCE® (fluticasone propionate), is a drug-device combination product that uses the Exhalation Delivery System met both co-primary endpoints in the ReOpen1 trial, demonstrating statistically significant benefits on symptoms and CT scans in patients with chronic sinusitis.
NUCALA (mepolizumab) is a monoclonal antibody that works by blocking a specific protein called interleukin-5. This is the fourth approved indication for NUCALA for Canadian patients with eosinophilic driven diseases.
XHANCE is a drug-device combination product that uses an Optinose Exhalation Delivery System (EDS™) that is designed to deliver a topical anti-inflammatory medication to high and deep regions of the nasal cavity.
Intersect ENT's PROPEL® and SINUVA® sinus implants are clinically proven solutions that open sinus passageways and deliver an anti-inflammatory steroid to aid in healing.
OTIPRIO is a sterile, preservative-free, otic suspension of 6 percent ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.
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