HealthDay News — Young patients with destructive nasal lesions commonly have current cocaine use, according to a study published online April 4 in Rheumatology Advances in Practice.

Charn Gill, from the University of Birmingham in the United Kingdom, and colleagues conducted a retrospective case series analysis of patients presenting with cocaine-induced midline destructive lesions or vasculitis compatible with granulomatosis with polyangiitis (GPA) between 2016 and 2021. A total of 42 patients (median age, 41 years) were identified with cocaine-induced midline lesions or systemic disease.

The researchers found that current cocaine use was common; when routine urine toxicology was performed, 20 of 23 samples provided were positive. Based on a urine toxicology analysis, 9 patients who denied ever using cocaine were identified as users and 11 tested positive despite stating that they were ex-users. High incidences of septal perforation and oronasal fistula were seen (75 and 15%, respectively). Systemic manifestations were seen in 27% of participants, and only one had acute kidney injury. Of the patients, 56% were PR3-ANCA positive and none tested positive for MPO-ANCA. Even when immunosuppression was administered, symptom remission required cocaine discontinuation.

“We now include urine samples for drugs of abuse in our initial investigations of patients with GPA and in those who appear not to be responding to treatment. Sadly, we have seen young people with life-changing disfigurement because of cocaine-induced granulomatosis with polyangiitis,” a coauthor said in a statement. “A better understanding of this condition prevents us from potentially harming patients further by administering inappropriate, potentially toxic, and futile treatment.”

Abstract/Full Text

The table below is a review of notable updates that occurred in May 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Nasal spray approved for chronic rhinosinusitis; Endothelin receptor antagonist gains approval to lower blood pressure in hypertension; One-time stem cell treatment approved for metachromatic leukodystrophy; NASH treatment gains accelerated approval; New automated insulin delivery system for type 1 diabetes.

Rhinitis & Nasal Congestion Treatments

HealthDay News — There is no difference in the risk for treatment failure for outpatient children with acute sinusitis treated with amoxicillin-clavulanate compared with amoxicillin, according to a study published in the September 19 issue of the Journal of the American Medical Association.

Timothy J. Savage, MD, from Brigham and Women’s Hospital in Boston, and colleagues compared amoxicillin-clavulanate vs amoxicillin for the treatment of acute sinusitis in outpatient children. The analysis included 198,942 propensity-matched patients (aged 17 years and younger).

The researchers observed no difference in the risk for treatment failure between the amoxicillin-clavulanate and amoxicillin groups (relative risk [RR], 0.98; 95% CI, 0.92 to 1.05). However, with amoxicillin-clavulanate, the risk for gastrointestinal symptoms (RR, 1.15; 95% CI, 1.05 to 1.25) and yeast infections (RR, 1.33; 95% CI, 1.16 to 1.54) was higher. Risk for treatment failure with amoxicillin-clavulanate varied by age (ages 0 to 5 years: RR, 0.98; 95% CI, 0.86 to 1.12; 6 to 11 years: RR, 1.06; 95% CI, 0.92 to 1.21; and 12 to 17 years: RR, 0.87; 95% CI, 0.79 to 0.95). The risk for adverse events with amoxicillin-clavulanate decreased with age (0 to 5 years: RR, 1.23; 95% CI, 1.10 to 1.37; 6 to 11 years: RR,1.19; 95% CI, 1.04 to 1.35; and 12 to 17 years: RR, 1.04; 95% CI, 0.95 to 1.14).

“These findings may help inform decisions for empirical antibiotic selection in acute sinusitis,” the authors write.

Abstract/Full Text (subscription or payment may be required)

Xhance is a drug-device combination therapy that delivers fluticasone, a corticosteroid, deep into difficult-to-access sinuses and sinonasal drainage tracts. The medication is delivered into the nose by actuating the pump spray into 1 nostril while simultaneously blowing (exhaling) into the mouthpiece of the device.

The approval was based on data from the phase 3 ReOpen1 (ClinicalTrials.gov Identifier: NCT03781804) and ReOpen 2 (ClinicalTrials.gov Identifier: NCT03960580) trials, which included patients with chronic rhinosinusitis who were randomly assigned to receive Xhance or placebo over 24 weeks.

The coprimary endpoints were the change from baseline in symptoms as measured by a composite score of nasal congestion, facial pain or pressure sensation, and nasal discharge at the end of week 4, and the change from baseline in percent of ethmoid and maxillary sinus volume occupied by disease as measured by CT scan. 

Findings from ReOpen1 and ReOpen2 showed that treatment with Xhance was associated with a statistically significant improvement on both endpoints compared with placebo. The safety of Xhance was generally consistent with its known profile. The most common adverse reactions were epistaxis, headache, and nasopharyngitis.

“Although chronic sinusitis is one of the most common diagnoses in outpatient physician visits, and surgery is available, there has never been a prescription medication approved by the FDA as safe and effective to treat the millions of patients without nasal polyps suffering from this debilitating disease, said Ramy Mahmoud, MD, MPH, CEO of Optinose. “We are thrilled to now be able to offer new hope to these patients and believe Xhance has the potential to become part of the standard of care for the treatment of chronic sinusitis.”