Philadelphia Business Journal l October 9, 2015
A Bucks County company that has developed a “bi-directional, breath-powered” drug-delivery system, is getting ready to file its second new drug application.
OptiNose of Yardley announced positive results from late-stage testing of OPN-375, an experimental treatment for nasal polyposis. It expects to seek Food and Drug Administration approval for the therapy next year.
OptiNose on Oct. 6 closed a round of financing that will provide it with up to $30 million in capital to support the development of OPN-375 and other products in its pipeline.
Nasal polyposis is a type of chronic nasal inflammatory disease. An estimated 28 million adults in the United States — or about one in eight people — suffer from severe chronic nasal inflammatory diseases.
CEO Peter Miller said the condition is now treated by oral medicines, intranasal therapies and surgery, without a lot of success for those 28 million disease sufferers. Miller said the problem is the drug developed to treat the condition, a nasal steroid called fluticasone, needs to be applied directly to the inflammation site in the nasal cavity to be effective. With traditional methods, he said, too much of the drug is either swallowed or runs out of the nose before reaching the nasal cavity.
OptiNose‘s drug-delivery technology, he said, overcomes that problem. “This is probably the single-best application of our technology because the disease is in the nose,” Miller said.
The company says its patented technology uses the natural functions of a patient’s breath to deliver medications beyond the nasal valve into deep, targeted areas of the nasal cavity. After receiving a dose of medicine in powder or liquid form, the patient exhales into the OptiNose device — naturally closing the soft palate and sealing off the nasal cavity from the throat. The exhaled breath carries medication from the device into one side of the nose through a specially shaped sealing nosepiece. Narrow nasal passages are gently expanded and medication is sent well beyond the nasal valve to targeted sites. After delivering medication to the targeted sites, air flows to the opposite side of the nasal cavity and exits through the other side of the nose rather than into the throat or lungs.
Miller said the company is undecided on how it will bring OPN-375 to the market. “We have options and choices,” he said. “We have the ability to commercialize the product on our own, but we are also exploring potential partnerships.”
OptiNose went the partnership route with its first new drug application last year, for a migraine headache treatment delivered using its technology. The application was filed with its licensing partner Avanir Pharmaceuticals. The application is under review by the FDA.