The U.S. Food and Drug Administration has granted approval for Zepbound (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults suffering from obesity. This medication is intended to be used alongside a reduced-calorie diet and increased physical activity, as announced by Eli Lilly and Co. (LLY) on Friday.
This approval comes as a result of findings from the SURMOUNT-OSA phase 3 clinical trials. These trials evaluated Zepbound at dosages of 10 mg and 15 mg for treating moderate to severe OSA in obese adults, both with and without the use of positive airway pressure (PAP) therapy over a year. Zepbound demonstrated a fivefold increase in effectiveness over a placebo in reducing breathing disturbances for those not undergoing PAP therapy, cutting breathing disruptions by 25 incidents per hour compared to five with placebo.
For those on PAP therapy, Zepbound resulted in a reduction of 29 breathing disruptions per hour, in contrast to six with placebo. After one year, 42% of those on Zepbound and 50% of those on Zepbound combined with PAP therapy saw disease remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.
Obstructive sleep apnea is a sleep-related disorder that involves partial or complete blockages of the upper airway during sleep, which can result in breathing interruptions (apnea) or shallow breathing (hypopnea), along with possible decreases in oxygen saturation and disturbances in sleep. Although snoring is a common indicator of OSA, fatigue, excessive daytime sleepiness, and disrupted sleep are also significant symptoms of this serious and often-overlooked condition.
Eli Lilly cautions that Zepbound may cause side effects including nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, allergic reactions (characterized by fever and rash), burping, hair loss, and gastroesophageal reflux disease.
