The FLECTOR (diclofenac epolamine) topical system (FDETS) was found to effectively and safely relieve pain from minor soft tissue injury among the pediatric population, according to findings from a phase 4 open-label study published in Clinical Drug Investigation.
Researchers sought to assess the safety and efficacy of FDETS in children, which has been approved for the treatment of acute pain in adults with minor strains, sprains, and contusions.
Patients aged between 6 and 16 years were enrolled in the study from 10 family medicine or pediatric practices in the US between 2014 and 2016. Eligible patients had a clinically significant minor soft tissue injury in the preceding 96 hours with spontaneous pain (≥3 on the 6-point Wong-Baker FACESÒ Pain Rating Scale) and were given 28 FDETS patches to be worn for 12 to 24 hours. Each FDETS patch contained 180 mg diclofenac epolamine. Patients were evaluated for local tolerability, efficacy, and pharmacokinetics.
A total of 104 patients were included in the study. Overall, 65.4% were boys; mean age of the study population was 11.6 years; 70.2% were White; body mass index (BMI) was 21.2; and 35.6% had injuries of the ankle, 10.6% of the knee, 10.6% of the foot, 9.6% of the wrist, 6.7% of the lower leg, and 16.9% had other injuries. Half of the study participants were aged between 6 and 11 years and the other half were aged between 12 and 16 years.
Older vs younger participants tended to report more pain (3.58 vs 3.37 points, respectively; P =.075). The majority of patients (93%) had a tolerability score of 0, indicating no skin changes. The highest score during the study was 1, indicating faint redness.
A total of 54 adverse events were reported by 32 patients. Common events included headache (n=9), pruritus (n=7), stomach discomfort (n=3), nausea (n=3), fatigue (n=2), dizziness (n=2), upper abdominal pain (n=2), erythema (n=2), and epistaxis (n=2). A total of 14 events may have been related to the use of the FDETS patch. None of the adverse events were serious.
According to physician assessment, all patients, except 1, exhibited clinical improvement and 83.7% achieved normal function with no pain. Younger children tended to achieve normal function than older children (90.4% vs 76.9%, respectively; P =.110).
Significant predictors of pain relief included baseline pain (c2=13.06; P <.001), age (c2=6.35; P <.012), and day (c2=261.11; P <.001).
The mean diclofenac concentration was 1.65 ng/mL at 24 hours, increasing to 1.80 ng/mL at the final follow-up. Younger vs older participants tended to have higher concentrations at 24 hours (mean, 1.83 vs 1.46 ng/mL) and had significantly higher concentrations at the final follow-up (mean, 2.49 vs 1.11 ng/mL; P =.002).
Compared with data from the CRO-PK-01-72 study, which included adult patients and used both patch and oral diclofenac applications, the geometric mean of diclofenac at less than 13 hours of last patch application was lower among the pediatric cohort (1.07 vs 1.18 ng/mL, respectively).
This study was limited by its unblinded design and the lack of a control group.
Overall, the researchers concluded, “The safety, efficacy, and pharmacokinetic profile of the FLECTOR topical system in the pediatric population was consistent with data in adults obtained from a previous study.”
Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Jones CA, Hoehler FK, Frangione V, Ledesma G, Wisman Jr PP, Jones C. safety and efficacy of the FLECTOR (diclofenac epolamine) topical system in children with minor soft tissue injuries: a phase IV non‑randomized clinical trial.Clin Drug Investig. Published online November 26, 2021. doi:10.1007/s40261-021-01101-x