Preterm birth (PTB) continues to be a leading cause of neonatal mortality and long-term complications globally, reinforcing the need for effective and safe tocolytic treatments. Atosiban, an oxytocin receptor antagonist, has emerged as a pivotal intervention for managing spontaneous preterm labour (sPTL) due to its targeted mechanism and favourable safety profile. This is especially critical in regions like India, where there is a significant therapeutic gap in the availability of effective, safe, and cost-efficient tocolytic agents.

Dosing regimens for Atosiban include a full course (48 hours), a brief course (14 hours), and a single bolus dose. The brief and bolus regimens are particularly advantageous in settings that prioritize shorter hospital stays or outpatient management, offering a more convenient and cost-effective approach. These regimens also provide the flexibility of repeat treatments if necessary, enhancing patient care adaptability. Extensive clinical studies have validated Atosiban's efficacy and safety across its various dosing regimens.

Although Atosiban has a high initial cost compared to its alternatives, such as β2-agonists and calcium channel blockers, its superior safety profile and targeted action result in fewer maternal and fetal side effects, thereby reducing overall healthcare costs. The ability to manage sPTL with shorter regimens alleviates the strain on healthcare resources and minimizes the need for intensive neonatal care, with significant cost savings.

Overall, Atosiban represents a valuable therapeutic option for managing preterm labour. Its proven efficacy, safety, and cost-effectiveness make it a preferred choice for tocolysis, particularly in high-risk pregnancies like those with diabetes or cardiac issues.

Abstract

Background:

The global burden of respiratory diseases in India has drawn attention due to their high prevalence, socioeconomic impact, and lack of effective prevention measures.

Objective:

This study aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of Paracetamol, Phenylephrine and Chlorpheniramine tablet in adults with common cold.

Methods: This study was conducted at four different locations across India and involved the participation of 200 individuals exhibiting common cold symptoms of recent onset. They were administered Maxtra®P tablets [FDC of Paracetamol 500mg, Phenylephrine Hydrochloride 10mg, and Chlorpheniramine Maleate 4mg] every 4 to 6 hours for a duration of 5 days. The primary endpoint focused on assessing the safety and tolerability of the investigational drug. This evaluation relied on the identification of adverse events (AEs) experienced by the patients and global assessment reported by both the Investigator and the patients. Secondary endpoint, aimed at analyzing efficacy, the proportion of patients achieving complete resolution and a reduction in the severity of symptoms.

Results:

Adverse events such as nausea and dizziness, mild in severity, were experienced by two patients. However, they were resolved without any sequelae and were found not related to the study drug. Patients and investigators rated the treatment as “good to excellent” in alleviating symptoms associated with common cold in 92.5% (n = 185) and 99.5% (n = 199) of adults respectively, suggesting a positive response. A comprehensive assessment of 11 symptoms of common cold was conducted to evaluate the efficacy of the study drug. Complete resolution from the symptoms was achieved in 75% of patients and a statistically significant (p< 0.0001) reduction was observed in individual symptom severity score on day 5 as compared to baseline. A notable reduction in TSS (Total Symptom Score) was demonstrated where mean TSS at baseline was 16.05 which was reduced to 0.41 at day 5 (mean diff: 15.64, CI: 14.61 to 16.67, p< 0.0001).

Conclusion: Paracetamol, Phenylephrine Hydrochloride and Chlorpheniramine Maleate FDC was well tolerated and efficacious in the symptomatic treatment of common cold in adults.