Abametapir

Published

dm+d

Unassigned

New Medicines

XeglyzePediculosis - single application

Information

Xeglyze
New molecular entity
Not Known
Promius

Development and Regulatory status

None
None
Approved (Licensed)
The US FDA has approved abametapir lotion for the treatment of head lice infestation in patients 6 months of age or older in the US [5].

Nov 17: Currently pre-registration in the US [4].


Q3 17: The agreement between Dr Reddy´s and Hatchtech is still ongoing [3].


Nov 16: announcing PIII trial results at the American Academy of Pediatrics 2016 National Conference, Hatchtech note that Promius, a US subsidiary of Dr Reddys, will apply for US approval [1].

Category

Metalloprotease inhibitor and chelating agent, targeting proteases essential to insect hatching and survival
Head lice infestation is very common worldwide: in the UK, children aged 4-11 are most commonly affected with a peak age of 7 to 8; published prevalence rates have ranged from 4.% to 22% [2].
Pediculosis - single application
Topical

Trial or other data

Nov 16: results from two PIII trials (NCT02060903, NCT02062060; total n=704) have been presented at the American Academy of Pediatrics 2016 National Conference. Participants, of whom about a third were children, had active head-lice infestation and were treated as households with a single application of abametapir 0.74% lotion or the lotion vehicle as placebo; primary outcome was proportion of index subjects lice-free at 14 days follow-up. For the two studies, in the total abametapir index subject group (n=187), cure rate was 88% and 81%, compared with 62% and 60.5% in the placebo groups (n=192 index subjects), p<0.001 for both trials. A high placebo response was expected as the vehicle contains mineral oil, which will act as a suffocant [1].