The Food and Drug Administration (FDA) has approved Xeglyze™ (abametapir; Dr. Reddy’s Laboratories) for the treatment of head lice infestation in patients aged 6 months and older.
Abametapir is a pediculicide that works by inhibiting metalloproteinases, which play a role in physiological processes critical to egg development and survival of lice. The product is indicated for use in the context of an overall lice management program that includes washing and drying all recently worn clothing, hats, used bedding and towels, washing personal care items (ie, combs, brushes, hair clips), and using a fine-tooth comb or special nit comb to remove dead lice and nits.
The approval was based on 2 identical, multicenter, double-blind, vehicle-controlled phase 3 trials (NCT02060903 and NCT02062060) that evaluated the efficacy and safety of abametapir lotion in 704 patients aged ≥6 months with head lice infestation. The primary end point was the proportion of patients who were free of live lice at follow-up visits on days 1, 7, and 14.
Results from both studies showed a significantly greater proportion of patients treated with abametapir were free of live lice at all follow-up visits compared with the vehicle group (81.1% [n=43] and 81.8% [n=45] in Trials 1 and 2, respectively vs 50.9% [n=28] and 47.2% [n=25] with placebo).
As for safety, the most common adverse reactions associated with treatment included erythema, rash, skin burning sensation, contact dermatitis, vomiting, eye irritation, pruritus, and hair color changes. Additionally, the use of drugs that are substrates of CYP3A4, CYP2B6 or CYP1A2 should be avoided within 2 weeks after application as concomitant use may lead to increased systemic concentrations of the interacting drugs.
Xeglyze lotion contains 0.74% w/w of abametapir and will be supplied 7oz bottles. Treatment involves a single application and any unused product should be discarded.
For more information visit drreddys.com.
- Dr. Reddy’s Laboratories received approval of XEGLYZE™ (abametapir) lotion, 0.74%, in the US. https://www.businesswire.com/news/home/20200727005324/en/Dr.-Reddys-Laboratories-received-approval-XEGLYZE%E2%84%A2-abametapir. Published July 27, 2020. Accessed July 27, 2020.
- Xeglyze [package insert]. Princeton, NJ: Dr. Reddy’s Laboratories; 2020.