Sometimes, the best way to improve something is right under your nose. And sometimes when you want to take a good drug and make it better, a new delivery device can do the trick.
Medical device maker Optinose recently showed that its technology — which propels medications deep into the nasal cavity — improved chronic sinusitis symptoms in a phase 3 clinical trial. The company plans to release results from a second part of the study in the second quarter of this year — a data package that could lead to U.S. FDA approval.
“We're taking proven medicines, putting them in our device and in essence creating an entirely new product out of that,” Optinose CEO, Peter Miller, says.
Millions of adults have chronic sinusitis, characterized by constant inflammation in the sinuses that causes headache, face soreness and difficulty breathing.The FDA hasn’t approved a treatment specifically for the condition, but that could soon change.
Optinose’s device, XHANCE, has already been cleared for a related condition called nasal polyps. But chronic sinusitis represents an even greater patient need — nearly 30 million people have sinusitis of some sort.
“The benefit we can bring to patients with this product is unbelievably significant,” Miller says. “It’s such a big disease area with no products approved currently.”
Breaking new ground
XHANCE was invented by Dr. Per Djupesland — a nasal and sinus disease specialist, who is also Optinose’s chief scientific officer — because his patients were unable to find long-lasting relief, even after surgeries or repeated courses of antibiotics.
Here’s how the technology works: A patient inserts the nosepiece into one nostril and blows through the mouthpiece, closing off the nasal cavity and preventing the loss of drug particles. These particles are then transported to the intended destination in the body.
In the randomized study with 332 people, Optinose’s device delivered either a placebo or an over-the-counter nasal spray called Flonase into the nasal cavities of randomized patients. The treatment group saw meaningful improvements in nasal congestion, facial pain, pressure sensation and nasal discharge after four weeks. After 24 weeks, CT scans showed a 24 percent disease reduction in the sinus cavities.
Adverse events — the most common was a nosebleed — occurred in more than 3% of trial participants. But the study was “the first pivotal registration trial I am aware of that shows significant effects on both subjective and objective endpoints in this disease,” said Dr. James Palmer, past president of the American Rhinologic Society, in a news release. “In particular, there are no prior phase 3 trials that show an intranasal drug treatment reduces inflammation inside the sinus cavities of people with chronic sinusitis.”
Miller called the clinical trial results “thrilling” after so much company work on the chronic sinusitis program. He joined as CEO in 2010 after falling in loving with the technology, he says. Prior to Optinose, Miller was the vice president of Walgreen’s health and wellness division following the company’s acquisition of Take Care Health Systems, for which he was co-founder and CEO.
Miller says Optinose plans to market the chronic sinusitis program to allergy physicians, a cohort the company is already familiar with through its nasal polyps treatment. But they don’t have the same ties with primary care physicians, and Optinose intends to narrowly license the program to a pharmaceutical company that would solely target this audience.
Besides nasal polyps and chronic sinusitis, Optinose is evaluating its technology to deliver other drugs or drug combinations, such as antibiotics, anticholinergics, antihistamines, mucolytics, leukotriene inhibitors and other medication classes.
Optinose is betting that its investments in research and development — and a sales force — will yield strong returns in the future.
In 2021, the publicly held company reported an $82.3 million net loss on revenue of $74.7 million. But with the recent phase 3 clinical trial results, an increase in nasal polyps prescriptions and patients more likely to visit physician offices as pandemic restrictions lift, the company forecasts a much-improved financial position over the long term.
“We've sort of gotten through the rough sledding of building a business to scale,” Miller says.