FDA Approves Mometasone Implant for Chronic Sinusitis

Yael Waknine

August 15, 2011

August 15, 2011 — The US Food and Drug Administration (FDA) has approved a novel implantable delivery system for mometasone furoate (Propel, Intersect ENT, Inc) that provides controlled drug delivery for patients with chronic sinusitis.

The device is the first in a class of products that offer controlled delivery of steroid medication directly to sinus mucosa. Once implanted via endoscopic surgery, the bioabsorbable, drug-releasing stent expands to prop open the ethmoid sinus and assure patency.

Propel delivery system for mometasone furoate

According to a company news release, FDA approval was based on data from 3 prospective US clinical trials (n = 205) that included a randomized, double-blind pilot study (the ADVANCE safety study) and the randomized, double-blind ADVANCE clinical trial. Results of the latter will be presented at the annual American Academy of Otolaryngology-Head and Neck Surgery conference in San Francisco, California, on September 11 to 14, 2011.

Data from these clinical trials show that use of the device prevents obstruction of the ethmoid sinus after surgery, thereby improving postoperative outcomes and reducing the likelihood of adverse events related to additional procedures or administration of systemic steroids.

In a study involving 43 patients (Int Forum Allergy Rhinol. 2011;1:23-32), use of the mometasone-eluting stent yielded a significant reduction in inflammation at days 21 to 45 compared with the control stent (P < .003), decreased frequency of polyp formation (P = .0391), and minimized adhesions (P = .0313). No device-related adverse events were reported, nor was there evidence of adrenal cortical suppression.

"The FDA approval of this innovative new product is great news for [ear, nose, and throat] clinicians and patients," said David W. Kennedy, MD, in the news release. "[The mometasone implant] reduces the occurrence of inflammation and scarring in the post-operative period. As a result, it promises to substantially improve long-term outcomes for sinus surgery and, as my research has demonstrated, reduced scarring and inflammation correlates with absence of the need for further surgery. I believe the combination of minimally invasive techniques and local drug delivery will be the wave of the future in sinus treatment."

Dr. Kennedy is professor of otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia.

Other formulations of mometasone furoate are already marketed in the United States for various disorders.

Mometasone furoate monohydrate, 50 μg nasal spray (Nasonex, Schering-Plough), is approved by the FDA for the treatment of allergic rhinitis and nasal congestion associated with seasonal allergic rhinitis in patients aged 2 years and older; treatment of nasal polyps in adults; and the prevention of seasonal allergy symptoms in patients aged 12 years and older.

Mometasone furoate, 110 μg and 220 μg oral inhalation powders (Asmanex Twisthaler, Schering), is approved for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

Mometasone furoate, 0.1% cream, ointment, and lotion (Elocon, Schering), is approved for the topical relief of inflammatory and pruritic manifestations of corticoid-responsive dermatoses.

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