Etofenamate

Benzyl Nicotine (BN) and etofenamate (ETO), when combined with methylparaben (MP) or benzyl alc. (BA), are highly effective for treating muscle and joint pain.This study presents a newly developed and verified RP-HPLC method for measuring ETO and BN in the presence of MP or BA in their dosage forms.The approach utilizes eight environmentally friendly tools and the BAGI white tool to assess their eco-friendliness and effectiveness.The method uses a photodiode array PDA detector at 254 nm and symmetry column (C18, 150 mm x 4.6 mm, 5μm) in an isocratic process with a mobile phase of 0.1% orthophosphoric acid and methanol in a (45:55, volume/volume) adjusted pH 6.5 with 0.2% triethylamine solution at a flow rate of 1.5 mL/min, separation was accomplished in RP-HPLC.The calibration curves exhibited linearity across the concentration levels specified in the approach.Therefore, the procedure has been effectively applied in laboratory evaluation for medications in the presence of MP or BA, showcasing the exceptional selectivity of this strategy.The recommended approach was executed using the Six Sigma methodol., resulting in a Cpk value greater than 1.33.The procedures were successfully validated based on the ICH standards

Topical nonsteroidal anti-inflammatory drug (NSAID) formulations provide significant pain relief with excellent tolerability in the local treatment of soft tissue injuries. This study aimed to assess the efficacy and safety of a novel etofenamate 70 mg medicated plaster for treatment of pain in patients with acute sprains, strains and contusions (bruises).

In this randomized, placebo-controlled trial patients with acute injuries of recent onset received etofenamate or placebo plasters (2:1) applied once daily for 7 days. Regular clinical assessments were made with focus on pain on movement (POM) in millimetres on a 100-mm visual analogue scale (VAS).

A total of 180 adult patients (mean age 34.5 ± 13.5 years; 49.4% female) were enrolled. Mean VAS values for POM were 70.0 ± 6.3 mm at baseline; at 72 h POM had reduced by 59.0 mm and 33.3 mm in the etofenamate and placebo groups, respectively. Least squares mean treatment difference was 25.0 mm (p value for analysis of covariance < 0.0001). Results were consistent across type of injury (sprain/strain or contusion). Clinically meaningful superiority of etofenamate versus placebo was also seen for POM at the 24-, 48-, 96- and 120-h visits (p < 0.0001). Time to reach meaningful (30%), optimal (50%) and complete (100%) reduction of POM was significantly shorter with etofenamate. A significantly greater proportion of patients using etofenamate rated their progress and/or treatment as 'good' or 'very good'. The responder rate (proportion of patients with at least 50% pain reduction at 72 h) was 98.3% for etofenamate and 38.3% for placebo, resulting in a number needed to treat of 1.7, a value consistent with high effectiveness. The plasters adhered well over the 24-h dosing period and were very well tolerated.

In the setting of acute sprains, strains and contusions (bruises) the etofenamate plaster has therapeutic efficacy that is comparable to that for the best available topical NSAID formulations.

2021-003778-30 (EudraCT number).