23 Dec 2024 • In a significant move, the U.S. FDA has approved tirzepatide for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity.

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Dr. Sally Seymour, M.D.

• This approval was based on results from the SURMOUNT-OSA phase 3 clinical trials.
• Tirzepatide (Zepbound (10 mg or 15 mg) was about five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy, leading to 25 fewer breathing disruptions per hour with Zepbound and five with placebo.
• In adults on PAP therapy, Tirzepatide led to 29 fewer breathing disruptions per hour compared to six with placebo.

The most common adverse effects included nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity reactions (typically fever and rash), burping, hair loss and GERD.

Source: FDA | Read Full Story