In the RESOLVE II clinical trial,

SINUVA was proven to reduce nasal obstruction/congestion and polyp burden1

In the RESOLVE II clinical trial,

SINUVA was proven to reduce nasal obstruction/congestion and polyp burden1

CO-PRIMARY ENDPOINTS

Patients with SINUVA experienced a 74% relative improvement in bilateral polyp grade compared to control at Day 901

  • Based on change from baseline on an 8-point scale, that represented a sum of 0 (no polyp) to 4 (obstructing passage) on each side.

Patients with SINUVA experienced a 30% relative improvement in nasal obstruction (NOC) score at Day 301

  • Based on change from baseline on a 4-point scale of 0 (no symptoms) to 3 (severe).

SINUVA delivered sustained symptom relief and reduced the percentage of patients eligible for revision sinus surgery2

SECONDARY ENDPOINTS

Reduced the percentage of patients eligible for revision sinus surgery at Day 902

  • Patients treated with SINUVA had a 61% decrease in the proportion of patients indicated for repeat ESS, compared to 37% in the control arm (p=0.0004)

Delivered up to 90 days of sustained symptom relief2

  • Patients treated with SINUVA experienced sustained symptomatic improvements in nasal obstruction/congestion, through Day 90 (p=0.0248)

Significantly reduced ethmoid sinus obstruction2

  • Patients treated with SINUVA had a significantly greater decrease in percent ethmoid sinus obstruction (p=0.0007)

Improved patients’ sense of smell2

  • Patients treated with SINUVA experienced a significant improvement in their self-reported sense of smell, on a six point Likert scale (p=0.047)

P-values for secondary endpoints were adjusted for multiplicity.

Expand for study design and endpoints

RESOLVE II was a randomized, controlled, single-blind, multicenter study with 300 adult patients diagnosed with chronic sinusitis with bilateral nasal polyps who had undergone prior bilateral total ethmoidectomy but were indicated for revision endoscopic sinus surgery.1

201 patients were assigned to the treatment group and underwent bilateral placement of SINUVA Sinus Implants in the ethmoid sinuses. The remaining 99 patients were assigned to the control group and underwent a placebo (sham) procedure.1

The implants were removed at Day 60 to allow blinded grading at Day 90, by three independent sinus surgeons. All patients [treatment and control groups] were required to use a mometasone furoate nasal spray once daily (200 mcg of mometasone furoate) through Day 90.1

Co-primary endpoints1

  • Change from baseline to Day 90 in bilateral polyp grade, as determined by an independent panel on a scale of 0 to 4 on each side (polyps obstructing nasal cavity)
  • Change from baseline to Day 30 in nasal congestion score, as determined by patients, graded on a scale of 0 to 3

Secondary endpoints 2

  • Proportion of patients still indicated for repeat ESS at Day 90 despite ongoing INS use based on clinical investigator assessment using study-specific criteria
  • Change from baseline to Day 90 in nasal obstruction/congestion score, as determined by patients, graded on a scale of 0 to 3
  • Change in percent ethmoid sinus obstruction at Day 90, as determined by the independent, blinded panel on a 100-mm visual analogue scale (VAS)
  • Decreased sense of smell score change from baseline to Day 90, as determined by patients on a six point Likert scale of 0 (absent) to 5 (very severe)



The safety of SINUVA has been studied in 400 patients in 2 randomized controlled trials1

Adverse reactions with >1% incidence and more common than control in 90-Day controlled clinical trials with SINUVA

Adverse reactionsSINUVA
(N = 254)
n (%)
Control
(N = 146)
n (%)
Asthma12 (4.7)6 (4.1)
Headache9 (3.5)5 (3.4)
Epistaxis6 (2.4)2 (1.4)
Presyncope6 (2.4)3 (2.1)
Bronchitis5 (2.0)2 (1.4)
Otitis media5 (2.0)2 (1.4)
Nasopharyngitis3 (1.2)1 (0.7)

One study monitored patients from Day 90 through 6 months. Hypersensitivity (4% (n=2) vs 0), chronic sinusitis (11% (n=6) vs 9% (n=4)), and upper respiratory tract infections (8% (n=4) vs 2% (n=1)) were reported in more than 2 patients in the treatment group, and more commonly than the control group during this time period.

Stay Up-to-Date on SINUVA

Sign up below for the latest information about the SINUVA Sinus Implant.

INDICATION

SINUVA™ Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥ 18 years of age who have had ethmoid sinus surgery.

IMPORTANT SAFETY INFORMATION

Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.

SINUVA is made from bioabsorbable polymers designed to soften over time. As the implant softens and polyps decrease, the implant may be expelled out of the nose on its own or with actions such as sneezing or forceful nose blowing. The implant can be removed 90 days after placement or earlier at the physician’s discretion. Repeat administration of SINUVA has not been studied.

As with other endoscopic sinus procedures, there are risks associated with the insertion or removal of SINUVA. SINUVA should be inserted by physicians trained in otolaryngology.

The nasal mucosa adjacent to the SINUVA Sinus Implant should be monitored for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid the use of SINUVA in patients with nasal ulcers or trauma.

The most common adverse reactions observed in clinical studies were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis.

Patients experiencing excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat, should immediately contact a healthcare professional.

Close monitoring is recommended if patients have a change of vision or a history of increased intraocular pressure, glaucoma and/or cataracts.

You may report side effects to your physician or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . You may also report side effects to Intersect ENT at 1-866-531-6004.

RX Only. For important risk and use information about SINUVA, please see Full Prescribing Information.

References: 1. SINUVA Prescribing Information, Intersect ENT. December 2017. 2. Data on File, Intersect ENT. RESOLVE II Rev 3.0 CSR R 28017; February 2017.

IMPORTANT SAFETY INFORMATION

Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids. If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal. Continue Reading

IMPORTANT SAFETY INFORMATION

Patients with a known hypersensitivity to the mometasone furoate drug or any of the ingredients in SINUVA, should not use SINUVA. Continue Reading

Start typing and press Enter to search