Abstract

EVALUATION OF SAFETY AND EFFICACY OF ERASAVIR NASAL AND MOUTH SPRAY COMBINATION IN UPPER RESPIRATORY VIRAL INFECTIONS: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY

Dibyendu Patra, Nilendu Sekhar Sarkar*, Darpan Roy Chowdhury, Anupam Dokeniya, Dino Rotondo, Anusmita Banerjee, Papri Nath

ABSTRACT

ErasaVir, an investigational antiviral formulation developed by Strassenburg Pharmaceuticals Pvt. Ltd., is designed as a dual-application mouth and nasal spray intended to inhibit viral replication and prevent viral adhesion in the upper respiratory tract. Comprising natural oil extracts such as linoleic acid, peppermint, and eucalyptus oils, ErasaVir offers a topical, variant-agnostic therapeutic approach for patients with allergic rhinitis and viral upper respiratory tract infections (URTI). The aim of this study was to evaluate the safety and efficacy of ErasaVir compared with standard rational therapy in adult patients with allergic rhinitis and/or viral URTI. This randomized, prospective, single-center, open-label, parallel-group, controlled Phase IV study enrolled 33 participants aged 18–80 years. Participants were randomized into two arms: Test (ErasaVir Mouth and Nasal Spray; n=17) and Reference (Rational Therapy; n=16). ErasaVir was administered twice daily for 7 days. Clinical assessments included symptom scoring (subject diary cards), vital signs, physical examinations, and throat swab culture. Statistical analysis was conducted on all participants who completed the study. This study showed Both groups were comparable at baseline in demographics, vitals, comorbidities, and laboratory values (p>0.05). The ErasaVir group demonstrated progressive symptomatic improvement from Day 2 onward, with marked reductions in chills, sore throat, discomfort, cough, and nasal symptoms by Day 7. Throat swab cultures remained normal in all subjects. No significant safety concerns or adverse events were reported, and treatment compliance was 100%. ErasaVir Mouth and Nasal Spray was well-tolerated and demonstrated favourable symptomatic improvement compared with rational therapy in patients with allergic rhinitis and viral URTI. These findings support ErasaVir as a safe and effective topical antiviral therapy.

Keywords: ErasaVir, Antiviral nasal and mouth spray, Allergic rhinitis, Upper respiratory tract infection (URTI), Clinical efficacy and safety.