Sleep is like sex. Everybody wants it and nobody is getting enough. That’s what Lars Knutsen of Requis Pharmaceuticals said the other day as part of a presentation for a snoring and sleeplessness treatment. But it’s just as relevant for the 18 million people who deal with obstructive sleep apnea. Although continuous positive airway pressure has been the go-to therapy for the condition, the breathing masks have an average adherence rate of 50 percent, and device developers have struggled to come up with alternatives.
An implant developed by Inspire Medical Systems that’s just been approved by the U.S. Food and Drug Administration could offer a passive way to more effectively treat the condition.
The Inspire Upper Airway Stimulation device includes a pulse generator, a sensing lead and a stimulation lead. Here’s how it works. Patients use a small handheld remote to activate the therapy right before they go to bed and turn it off when they wake up. The implant detects breathing patterns and sends a mild stimulation to airway muscles to keep airways open during sleep. It has a battery life of 10 years, according to documents submitted to the FDA.
The treatment has been approved for obstructive sleep apnea patients who can’t use CPAP or won’t use it. It’s expected to be available in the second half of the year.
Although surgical options have existed for awhile, Inspire claims it offers a less invasive option that doesn’t involve altering a patient’s airway.
The company was formed in a spin-off from Medtronic in 2007.
The 126 patients who participated in a pivotal clinical trial experienced a 68 percent reduction in apnea events, according to a company statement. As part of an agreement with the FDA, the company will monitor trial participants for five years.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The impact of OSA is pretty far-reaching. People with the condition are at increased risk for heart attack, stroke, weight gain, high blood pressure, heart failure and falling asleep while driving, all of which boost healthcare costs.
