FDA Clears New Steroid-Releasing Implant For Chronic Sinusitis Patients

In short

Intersect ENT, Inc., has announced U.S. FDA approval of the company’s second steroid-releasing product, PROPEL™ mini. The company says this will allow more patients suffering from chronic sinusitis to benefit from localised drug delivery.

Background

Chronic sinusitis is a condition in which patients’ sinuses become swollen and inflamed, leading to difficulty breathing, facial pain or headache, and reduced sense of smell and taste. The condition is common, estimated to affect 31 million people in the U.S.,1 and greatly impacts quality of life.

Chronic sinusitis often requires a complex combination of surgical and medical treatments. Each year, 500,000 patients undergo sinus surgery to treat the condition.2 Although sinus surgery is effective, the majority of patients experience recurrent symptoms within the first year; as many as 25 percent then undergo revision surgery due to recurrent obstruction of the sinus cavity.3

The PROPEL™ mometasone furoate implant, approved last year by the FDA, is a spring-like implant that is inserted by a physician following endoscopic sinus surgery. The implant expands to prop open the sinus, gradually delivers an advanced steroid with anti-inflammatory properties directly to the sinus lining, then dissolves into the body. The result is improved surgical outcomes, reducing the need for additional surgical procedures and for systemic steroids, which can have serious side effects.

PROPEL mini, the second in a pipeline of localised drug delivery products in development by Intersect ENT, is a smaller version of PROPEL. PROPEL mini offers the same clinical benefits and dose of mometasone furoate provided by PROPEL, allowing patients with less extensive surgery and smaller anatomy to benefit from improved surgical outcomes.

Physician comments

“PROPEL has been recognized as a revolutionary advancement in the treatment of chronic sinusitis from both a technological and a clinical perspective,” said Dr. Joseph Jacobs, Professor and Director of Rhinology at NYU Langone Medical Center NY, NY. “Clinical studies have clearly demonstrated that localized drug delivery offers significant advantages for patients undergoing endoscopic sinus surgery. My surgical patients have benefited from the addition of PROPEL to their care, and I am pleased that I will soon be able to offer this innovative treatment to a broader range of my patients.”

Company comments

“We are excited that the significant clinical benefits of PROPEL will now be available to more patients suffering from chronic sinusitis, a condition that has a severe impact on quality of life,” said Lisa Earnhardt, the company’s president and CEO. “PROPEL mini and PROPEL, clinically proven to maintain sinus patency after surgery, are the first and only products for patients undergoing sinus surgery to be backed by Level 1-A clinical evidence. Bringing two combination products to market in just over a year illustrates Intersect ENT’s commitment to delivering meaningful products to our ENT customers and their patients.”

Availability 

Intersect ENT initiated sales of PROPEL in limited regions of the U.S. over the past year. PROPEL mini will be offered in select hospitals starting this month and will be launched nationwide in conjunction with a planned sales force expansion in 2013.

References

1 Pleis JR, Lethbridge-Çejku M. National Health Interview Survey, 2006. National Center for Health Statistics. Vital Health Stat 10(235). 2007

2 Rosenfeld et al. Clinical practice guideline: Adult sinusitis. Otolaryngology–Head and Neck Surgery. 137, S1-S31, 2007.

3 Shaitkin et al. Endoscopic Sinus Surgery. Laryngoscope, 103, Oct 1993.

4 Kennedy DW, Wright ED, Goldberg AN. Laryngoscope. 2000;110:29–31.

Source: Intersect ENT, Inc., Business Wire