CHICAGO – A novel one-time topical treatment for head lice, abametapir, was well tolerated in children as young as 6 months, according to pooled results from 11 clinical trials.
The pooled safety data included results from 11 clinical trials including 1,372 patients. Of these, 700 were aged 6 months to 17 years, and patients were exposed to the novel metalloproteinase inhibitor for 10-20 minutes.
In examining safety data from the pooled trials, Lydie Hazan, MD, of Axis Clinical Trials and her collaborators found that for pediatric patients, most treatment-emergent adverse events (AEs) were skin and subcutaneous tissue-related. The most common AEs were erythema, rash, a burning sensation on the skin, and contact dermatitis.
Data for the three phase II pharmacokinetic trials, the phase II ovicidal efficacy trial, and the two phase III trials were reported separately by Dr. Hazan and her coauthors in a poster presentation at the World Congress of Pediatric Dermatology. The overall incidence of treatment-emergent AEs in the studies ranged from 20% to 29% for patients in the active arms of the trials. For patients who received the vehicle lotion only, the incidence of AEs ranged from 16% to 57%.
©CDC/Reed & Carnrick Pharmaceuticals
Of the 11 trials, 6 involved pediatric patients, with one phase IIB trial, one phase II ovicidal trial, two maximal-use open-label trials, and two phase III randomized, double-blind, vehicle-controlled trials. Of the 920 patients, in most of the trials they received a 10-minute exposure to the study drug (489 received abametapir lotion 0.74%, 431 received vehicle lotion).
Looking just at the phase III trials, 24% of patients in the abametapir arm reported AEs, while 19% of those receiving vehicle reported any AE.
In the two maximal-use pediatric trials, drug exposure ranged from 3.3 g to 200.8 g; AEs in these two trials occurred in 23% of participants.
Safety data collected for all studies also included vital signs, results of physical exams, and laboratory tests; no “clinically meaningful” changes were seen in any of the trials for any of these values, according to Dr. Hazan and her coauthors.
“AEs were mild, not age-related, and primarily in the system organ class of skin and subcutaneous tissue disorders,” said Dr. Hazan and her coauthors.
Abematapir 0.74% lotion had previously been shown to be an effective ovicidal treatment for head lice when used in a single application; the lotion is intended to be applied at home by the patient or caregiver (J Med Entomol. 2017. 54[1]:167-72).*
Dr. Hazan is employed by Axis clinical trials. Other study authors were employed by Hatchtech, which developed abametapir, and by Promius Pharma/Dr. Reddy’s Laboratories, which plans to market abametapir lotion.
*Correction, 8/7/17: An earlier version of this article had an incorrect citation.
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