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 .
Nov 17: Currently pre-registration in the US .
Q3 17: The agreement between Dr Reddy´s and Hatchtech is still ongoing .
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 .
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% .
Pediculosis - single application
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 .