Mucinex ® D plus antibiotic relieves symptoms faster in patients with an acute respiratory infection compared with patients receiving antibiotic therapy alone

®D (guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg extended-release bi-layer tablets), an expectorant/nasal decongestant, in providing relief of respiratory symptoms when used as adjunctive therapy to antibiotics in patients with an acute respiratory infection (ARI). Methods: Adult patients aged 18-75 years with ARI, and with a total symptom score of 10 based on a 0-to-3 severity rating of 10 respiratory symptoms (chest congestion, cough, thickened sputum/phlegm, runny nose, nasal congestion, sinus headache, facial pain/pressure/tenderness, post-nasal drip, sore throat, and breathlessness), were prescribed an antibiotic regimen (determined by the treating physician) and received two Mucinex® D extended-release bi-layer tablets or a matching placebo BID for 7 days. As per study protocol, patients were taking no prior or concomitant medications for ARI. Approval was obtained from the Quorum Review Inc. Institutional Review Board, and written informed consent was obtained from all patients. Patients completed symptom diaries and treatment assessments twice daily and attended doctor visits on Days 4 and 8. Efficacy was assessed in intent-to-treat (ITT) and per-protocol analyses. Safety was assessed throughout the study. Results: Data from the 30-center ITT population (n=601; Mucinex ® D=303, placebo=298) showed lower mean symptom scores with Mucinex ® D group vs placebo group starting on Day 3 in every symptom assessed, with statistically significant improvements in total symptom score (p=0.026). A larger percentage of patients in the Mucinex® D group felt that the medication was helping during the day at each time point assessed, and statistically significant differences in favor of the Mucinex® D group were observed as early as Day 2 (p=0.002). The time to overall relief (no symptom worse than mild) was also significantly shorter in the Mucinex® D group than in the placebo group (p=0.038). The greatest differences between study groups were observed for nasal congestion and sinus headache. The difference in mean symptom score for nasal congestion was statistically significant in favor of the Mucinex® D group at the Visit 2 (p=0.010) and Visit 3 (p=0.004) assessments, and for all diary self-assessments on Days 3 through 8. For sinus headache, the difference in mean symptom score was statistically significant for diary assessments from the morning of Day 2 (p=0.022) through the morning of Day 3 (p=0.019), and from the evening of Day 4 (p=0.010) through the evening of Day 7 (p=0.044). The incidence of adverse events related to study medication was 9.9% in the Mucinex® D treatment group and 5.7% in the placebo group. The most frequently reported adverse event leading to treatment discontinuation was insomnia (seven patients in the Mucinex® D group [2.3%] and two patients in the placebo group [0.7%]). No serious adverse events or deaths were reported in either treatment group during the study.