The US Food and Drug Administration (FDA) has approved mometasone furoate in the treatment of chronic sinusitis, based on the data from three prospective US clinical trials. Mometasone will be available to the patients of chronic sinusitis in the form of an implantable delivery system, which will provide controlled drug delivery. The device, which is the first of its kind, will be implanted through endoscopic surgery. The bio-absorbable, drug-releasing stent will open the ethmoid sinus and assure that it remains patent. The three clinical trials, on which the FDA approval is based, provided evidence that the Mometasone device prevents the obstruction of ethmoid sinus post surgery. Therefore, the patients do not require additional procedures or administration of systemic steroids.
In one of these studies published in the journal “International Forum of Allergy and Rhinology, Andre H. Murr and his colleagues studied the effect of the mometasone-eluting stent after surgery, in 43 patients of chronic sinusitis. They found a significant reduction in inflammation at days 21 to 45, decreased frequency of polyp formation, and minimized adhesions. Moreover, there was no evidence of adrenal cortical suppression normally associated with other steroids. No adverse effects related to the implanted device were noticed.
According to Dr. David W. Kennedy, MD, a professor of otorhinolaryngology at the University of Pennsylvania Health System in Philadelphia, patients suffering from problems related to sinus will greatly benefit with this device. As the device reduces the occurrence of inflammation and scarring in the post-operative period, it will eventually lead to decreased need for additional surgeries and improve the patient’s long term prospects. He believes that the future of sinus treatment will be a combination of minimally invasive techniques and local drug delivery. Mometasone furoate is already in use as a nasal spray in the treatment of allergic rhinitis and nasal congestion associated with seasonal allergic rhinitis while it is used as inhalation powder for the maintenance treatment of asthma.
References:
- http://www.medscape.com/viewarticle/748029?src=mpnews&spon=34
- http://onlinelibrary.wiley.com/doi/10.1002/alr.20020/abstract
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