Publication:

Assessing the impact of a fixed dose combination of camylofin and mefenamic acid on the onset of pain relief in patients with moderate to severe dysmenorrhea

Background A fixed-dose combination (FDC) of camylofin 50 mg and mefenamic acid 250 mg was found to be effective and safe following 5 days of treatment in women with primary dysmenorrhea. Here, we assess the onset of analgesia FDC within 24 hours of administration of the FDC using two independent patient-reported outcome tools.

Method In this prospective, single-center study, 140 women with moderate-to-severe primary dysmenorrhea received 3 tablets of the FDC over 24 hours. Primary endpoints were time to pain relief using the 11-point numerical rating scale (NRS-11) and the 100-mm visual analog scale (VAS) and proportion of patients with pain relief in the first 2 hours post-1st dose administration. Pain relief was defined as ≥1-point reduction in pain score on both scales. Secondary endpoints were change in pain intensity scores from baseline to 24 hours post-1st dose using both scales and incidence of adverse events (AEs).

Results Median duration of onset of pain relief using NRS-11 and VAS was 50-and 20-minutes post-1st dose, respectively. Statistically significant reductions (p˂0.0001) post 1st dose was observed from 40 minutes on the NRS-11 and at all post-baseline timepoints on the VAS. Only 3 patients (2.1%) reported treatment emergent AEs, all of which were related to the study drug, ‘mild’ in intensity, and resolved without sequalae.

Conclusions The FDC of camylofin and mefenamic acid provided analgesia onset within 20 min on VAS and 50 min on NRS after administration of first dose and a good safety profile in women with primary dysmenorrhea.