Assessment of the acceptability of effervescent oxycodone/paracetamol in the management of moderate-to-severe pain: the FirAlgos study

Eur Rev Med Pharmacol Sci. 2026 May;30(5):181-191. doi: 10.26355/eurrev_202605_37822.

ABSTRACT

OBJECTIVE: Chronic pain affects approximately one quarter of the Italian adult population and represents a major public health burden, significantly impairing quality of life and functional capacity. When first-line analgesics are insufficient, opioid combinations such as oxycodone/paracetamol (OXY/PAR) are recommended. The effervescent formulation of OXY/PAR was developed to improve administration and acceptability, particularly in frail patients or those with swallowing difficulties. The FirAlgos study evaluated its real-world effectiveness and patient-reported acceptability.

MATERIALS AND METHODS: This retrospective observational study included adult patients treated with effervescent OXY/PAR for moderate-to-severe pain (NRS >5) at a tertiary Pain Therapy Center (2022-2023). Assessments were performed at baseline (T0), Day 7 (T1), and Day 14 (T2). Outcomes included pain intensity (Numeric Rating Scale, NRS), pain interference (Brief Pain Inventory, BPI), Patient Global Impression of Change (PGIC), and treatment satisfaction. Longitudinal changes were analyzed using Friedman's Chi-Square test with Wilcoxon post-hoc correction.

RESULTS: Ninety-four patients were included (mean age 69.3 ± 13.3 years; 59.6% female; 75.5% non-oncologic pain). Significant reductions in NRS scores were observed between T0 and T1 across all pain dimensions in both oncologic and non-oncologic groups (p < 0.05), with stabilization at T2. PGIC scores showed a rapid upward shift toward higher perceived improvement categories, maintained at follow-up. BPI analyses demonstrated significant early improvements in functional domains, particularly general activity, mobility, and work capability, with sustained benefit over time.

CONCLUSIONS: In real-world clinical practice, the effervescent OXY/PAR formulation provided rapid, clinically meaningful, and sustained pain relief, with parallel improvements in functional outcomes and patient-perceived benefit. Its high acceptability supports its use in patients requiring flexible and easily administrable analgesic options for moderate-to-severe pain.

PMID:42237960 | DOI:10.26355/eurrev_202605_37822