A drug administered through a nasal spray may be an alternative treatment option for patients with obstructive sleep apnea by improving upper airway collapsibility, according to a study published in CHEST.

This is the first time the drug, a novel, potent, TWIK-related acid sensitive K+ (TASK) 1/3 channel antagonist, was studied in humans.

“Although a small study, our findings represent the first detailed investigation of this new treatment in people with OSA, with promising results,” Amal M. Osman, PhD, of Flinders University’s sleep lab FHMRI: Sleep Health, said in a press release. “The drug we tested is designed to target specific receptors that are expressed on the surface of the upper airways, triggering them more easily to activate the surrounding muscles to keep the airway open during sleep. While there’s still a long way to go in terms of clinical testing and development, our study shows targeting these receptors may be a promising avenue for future treatments.”

In a double-blind, randomized, crossover study, Osman and colleagues studied 12 patients (50% women; median age, 57 years) with obstructive sleep apnea to find out if BAY2586116 (Bayer), a TASK 1/3 K+ channel antagonist, could help airways stay open during sleep.

For two overnight physiology studies, researchers randomly gave patients either 160 µg of BAY2586116 or a placebo nasal spray. After these two nights, the participants could also take part in three more overnight studies in which they all received BAY2586116 but through a different application method each night, including BAY2586116 nasal drops (n = 10), half-dose nasal spray (n = 10) or direct application using an endoscope (n = 8).

Various tools, including polysomnography equipment, an epiglottic pressure catheter, pneumotachograph and a nasal mask, were used to track patients’ sleeping and breathing patterns over the course of receiving the drug.

Measuring for upper airway critical closing pressure during sleep, researchers found a mean value of 2.1 ± 1.8 cmH₂O (range, –0.16 to 5 cmH₂O) among patients who received the placebo nasal spray. However, the BAY2586116 spray lowered the upper airway critical closing pressure to 0.1 ± 4.4 cmH₂O (range, –5.7 to 9.7 cmH₂O).

Additionally, researchers found that all applications and doses of BAY2586116 that they tested lowered and improved the critical closing pressure among patients, with nasal drops at 0.9 ± 2.6 cmH₂O, the half-dose spray at 0 ± 2.2 cmH₂O and endoscope application at 0.4 ± 3.3 cmH₂O.

Although approximately 60% of patients had a greater than 2 cmH₂0 improvement with the nasal spray method compared with only 20% of patients using the nasal drop method, results of a mixed model showed no systemic differences between the different modes of application and dose.

When CPAP had transient reduction to atmospheric pressure, 82% of 11 patients had no flow for breaths 3 to 5 during treatment with placebo, but the average peak inspiratory flow responses increased when BAY2586116 high-dose spray and endoscope were used.

“At the moment, there are no approved drug treatments for OSA,” Danny J. Eckert, PhD, director of the Flinders’ sleep lab FHMRI: Sleep Health, said in the release. “However, with advances in our understanding of the different reasons people get OSA, the potential for effective new medications is growing stronger each year.”