FDA APPROVED FIRST DRUG RELEASING IMPLANT FOR CHRONIC SINUSITIS PATIENTS

The U.S. Food and Drug Administration (FDA) approved the Intersect ENT, Inc.’s Pre-market Approval (PMA) application for the Propel™ mometasone furoate implant offering localized, controlled drug delivery for chronic sinusitis patients.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, affecting one in seven adults in theU.S., 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.  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.Propel is the first of a new category of products offering localized, controlled delivery of steroid directly to the sinus tissue. Inserted by a physician following endoscopic sinus surgery, the spring-like implant expands to prop open the sinus and gradually delivers an advanced corticosteroid with anti-inflammatory properties directly to the sinus lining to maintain sinus patency.The Propel system has been clinically proven to prevent obstruction of the ethmoid sinus following surgery. The result is improved post-operative outcomes, reducing the need for additional surgical procedures and systemic steroids that can have serious side effects.

REFERENCES

1.     www.globalpharmasectornews.com

2.     www.medscape.com

3.     www.qmed.com

4.     www.emedicinelive.com

5.     www.pharmabiz.com

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