Optimal Dosage Regimen of Grammidin® with Anesthetic in the Treatment of Acute Infectious Inflammatory Conditions of the Pharynx

The aim of the study was to evaluate the efficacy and safety of two dosing regimens of Grammidin® with anesthetic (metered-dose oropharyngeal spray) in the treatment of acute infectious inflammatory conditions of the pharynx. Materials and methods. The study included a total of 222 patients presenting with sore throat as the predominant symptom, diagnosed with acute pharyngitis, acute nasopharyngitis, or acute exacerbation of chronic pharyngitis. Participants were randomized in a 1:1:1 allocation ratio to 3 parallel groups of equal size (N = 74 per group). Patients randomized to group 1 received Grammidin® with anesthetic (metered-dose oropharyngeal spray), 2 sprays every 6 hours (3 times daily) after meals; participants in group 2 received the same formulation, 4 sprays every 6 hours (3 times daily) after meals; and participants in group 3 received Septolete® Total (lozenges; benzydamine hydrochloride 3 mg and cetylpyridinium chloride 1 mg), 1 lozenge every 6 hours (3 times daily). The treatment duration was 7 days. Efficacy was assessed based on: reduction in sore throat intensity, measured using a visual analog scale (VAS); changes in symptom severity according to the Tonsillopharyngitis Clinical Scoring Scale; presence and severity of erythema and edema of the pharyngeal and tonsillar mucosa, as well as the severity of systemic intoxication symptoms. Results. Primary endpoint analysis (ITT population) confirmed a statistically significant dose-related effect of Grammidin® with anesthetic: the 4-spray regimen demonstrated greater reduction in VAS throat pain scores 60 minutes after the first administration in contrast with both comparators. Mean differences (rounded to 1 decimal place) were 9.29 mm in the Grammidin® with anesthetic 2-spray regimen group and 11.66 mm in the Septolete® Total group, respectively. By day 8, all patients demonstrated clinically significant improvement, with no statistically significant between-group differences (P = 0.197). Per-protocol analysis on day 8 confirmed sustained symptomatic benefit of Grammidin® with anesthetic over Septolete® Total across both dose levels on the Tonsillopharyngitis Clinical Scoring Scale (2 sprays vs comparator: P = 0.008; 4 sprays vs comparator: P = 0.024), supporting a consistent clinical benefit. Conclusion. The 4-spray, 3-times-daily (after meals) regimen of Grammidin® with anesthetic for 7 days demonstrated a clinically relevant benefit over both the 2-spray regimen (3-times-daily after meals) and the active comparator, Septolete® Total (1 lozenge every 6 hours 3 times daily), in the treatment of acute infectious-inflammatory pharyngeal conditions. The safety profile of Grammidin® with anesthetic was consistent across dose levels, with no clinically important differences observed relative to Septolete® Total.

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