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Ramy Mahmoud, MD: Phase 3 Trials for Chronic Rhinosinusitis Treatment

During a recent interview regarding ReOpen1 and ReOpen2 trials, Dr. Mahmoud described a new treatment device for chronic rhinosinusitis patients.

In an interview with HCPLive, Ramy Mahmoud, MD, preventative medicine specialist and Chief Operating Officer/President of Optinose, Inc., discussed the results of recent clinical trials for the treatment of acute exacerbations of chronic rhinosinusitis (CRS).

Mahmoud went into his account of new data from the ReOpen1 and ReOpen2 trials, presented at IDWeek 2022, describing the results and what they mean for sinusitis treatment.

“The main takeaway is that we have new data,” Mahmoud said. “We're presenting the results from two new randomized controlled trials, evaluating a question which hasn't been asked before or never been successfully answered before, which is, is it possible to reduce acute exacerbations of chronic rhinosinusitis and antibiotic use that accompanies that chronic sinusitis, which is called chronic rhinosinusitis.”

Mahmoud described the major issues patients with CRS are facing with regard to their current treatment options.

“It turns out that 80% of the time patients who have chronic rhinosinusitis really don't get satisfactory relief.”

“And the reason is because the sinuses and the sinus drainage tracts and those more posterior and superior areas in the middle meatus, sort of behind the middle turbinate above the inferior turbinate,” he said. “Those are the areas where inflammation is causing the obstruction of ventilation and drainage from the sinus cavities, and they're just not reached very effectively by standard nasal sprays.

He went on to describe the new drug-device combination product designed to treat CRS, known as EDS-FLU (XHANCE), and the way it works for patients.

“It's a novel device. And the device enables the delivery of the topical steroid into these deeper, higher up target sites that are affected in chronic sinusitis.”

“It does that by during delivery, you seal the soft palate, you exhale against a resistance and that seals the soft palate…So in our case, that's a good thing, because then you delivered the drug with exhalation, you introduced the aerosol medicine, with the exhaled breath into one side of the nose with the sealing nose piece to transfer the pressure from the mouth,” he described. “And what you get is bi-directional flow in the air and drug flows in one side and then out the opposite nostril and not into the throat.”

Mahmoud then discussed his views on gaps in research in this field, as well as his hopes for EDS-FLU’s approval by the US Food and Drug Administration (FDA) in the near future.

“Well, it is my hope that with these two controlled trials, which showed a significant reduction up to two thirds in the acute exacerbations, especially with chronic rhinosinusitis, and with the antibiotic use that accompanies that…that we'll be able to put together a package that's suitable for the FDA to approve that and make the product broadly available,” he said. "This is important because today there are no approved therapeutic treatments until a clinician suspects that polypoid tissue is developing in a patients with chronic sinusitis. Of the 30 million patients with CS in the US, less than 1 million are diagnosed with nasal polyposis leaving clinicians with limited options for the vast majority of CS patients.”

To learn more about the condition of CRS, as well as information about the trial data referred to by Dr. Mahmoud, watch the interview above.