"Abametapir"

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                            1
                            2020Emergency Medicine Journal Club
                            Clinical studies evaluating abametapir lotion, 0.74%, for the treatment of head louse infestation EVMS Emergency Medicine Journal Club Therapy Worksheet Resident: Gavin Rogers Date: 4/22/20 Citation: Bowles VM, VanLuvanee LJ, Alsop H, et al. Clinical studies evaluating abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatric Dermatology. 2018;35:616–621 . Objective: To test the efficacy of abametapir vs. vehicle solution to clear lice infestation without nit combing. Methodology (design, inclusion and exclusion criteria, interventions compared, outcomes evaluated) Design: Two randomized, double‐blind, multicenter, parallel group single-dose vehicle‐controlled studies in subjects aged 6 months to 61.1 years. Inclusion: Eligible subjects were male
                            2
                            2020FDA - Drug Approval Package
                            Abametapir (Xeglyze) - To treat head lice Drug Approval Package: XEGLYZE * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines
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                            3
                            2019Global pediatric health
                            Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Few head lice treatments have demonstrated effectiveness against louse eggs. Abametapir, a metalloproteinase inhibitor, is able to target metalloproteinases critical to egg hatching and louse development. In this double-blind, phase 2 study, 50 subjects aged ≥3 years with active head lice infestation were randomized to receive a single treatment of abametapir lotion, 0.74%, or vehicle (control), applied to scalp and hair for 10 minutes. Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject's hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64.0% for vehicle
                            4
                            2018Pediatric dermatology
                            Clinical studies evaluating abametapir lotion, 0.74%, for the treatment of head louse infestation There is a need for better control of head louse infestations. Abametapir is an inhibitor of metalloproteinases critical for louse survival and egg development. The efficacy of abametapir lotion, 0.74%, was assessed for its ability to clear head louse infestations after a single application. Two randomized, double-blind, multicenter, vehicle-controlled studies were conducted in subjects aged 6 months and older to compare the effectiveness of abametapir lotion versus vehicle control for eliminating head louse infestations without nit combing. Abametapir lotion was applied to dry hair for 10 minutes on day 0 and then rinsed with water. The primary endpoint was the proportion of index subjects
                            5
                            2016Journal of medical entomology
                            Ovicidal Efficacy of Abametapir Against Eggs of Human Head and Body Lice (Anoplura: Pediculidae) Studies were undertaken to determine the ovicidal efficacy of 5,5'-dimethyl-2,2'-bipyridyl (abametapir) against eggs of both human head and body lice. Head lice eggs of different ages (0-2, 3-5, and 6-8-d-old eggs) were exposed to varying concentrations of abametapir in isopropanol and concentration -dependent response relationships established based on egg hatch. One hundred percent of all abametapir-treated eggs failed to hatch at the 0.74 and 0.55% concentrations, whereas 100% of 6-8-d-old head louse eggs failed to hatch only at the 0.74% concentration. The LC value for abametapir varied, depending on the age of the head lice eggs, from ∼0.10% recorded for 0-2-d-old eggs and increasing to ∼0.15
                            6
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            7
                            2014eMedicine Pediatrics
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            8
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            9
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            10
                            2014eMedicine.com
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            11
                            2014eMedicine.com
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            12
                            2014eMedicine Pediatrics
                            treatment. A phase 3 study showed that spinosad was more efficacious in clearing head lice than permethrin (P< 0.001). [34] Abametapir (Xeglyze) is a topical 0.74% lotion indicated as a single 10-minute treatment for head lice in patients aged 6 months and older. It acts by inhibiting metalloproteinase, which is critical to egg development and survival of lice.Two studies (n=704) showed that 81.5 % of abametapir treated individuals were free of lice 2 weeks after a single application compared with 49.1% treated with vehicle (P < 0.001). [59] Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64% for vehicle. Accounting
                            13
                            that spinosad was more efficacious in clearing head lice than permethrin (P< 0.001). [34] Abametapir (Xeglyze) is a topical 0.74% lotion indicated as a single 10-minute treatment for head lice in patients aged 6 months and older. It acts by inhibiting metalloproteinase, which is critical to egg development and survival of lice.Two studies (n=704) showed that 81.5% of abametapir treated individuals were free of lice 2 weeks after a single application compared with 49.1% treated with vehicle (P < 0.001). [59] Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64% for vehicle. Accounting for pretreatment hatch rates, the absolute
                            14
                            treatment. A phase 3 study showed that spinosad was more efficacious in clearing head lice than permethrin (P< 0.001). [34] Abametapir (Xeglyze) is a topical 0.74% lotion indicated as a single 10-minute treatment for head lice in patients aged 6 months and older. It acts by inhibiting metalloproteinase, which is critical to egg development and survival of lice.Two studies (n=704) showed that 81.5 % of abametapir treated individuals were free of lice 2 weeks after a single application compared with 49.1% treated with vehicle (P < 0.001). [59] Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64% for vehicle. Accounting
                            15
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            16
                            2014eMedicine Pediatrics
                            treatment. A phase 3 study showed that spinosad was more efficacious in clearing head lice than permethrin (P< 0.001). [34] Abametapir (Xeglyze) is a topical 0.74% lotion indicated as a single 10-minute treatment for head lice in patients aged 6 months and older. It acts by inhibiting metalloproteinase, which is critical to egg development and survival of lice.Two studies (n=704) showed that 81.5 % of abametapir treated individuals were free of lice 2 weeks after a single application compared with 49.1% treated with vehicle (P < 0.001). [59] Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64% for vehicle. Accounting
                            17
                            2014eMedicine.com
                            that spinosad was more efficacious in clearing head lice than permethrin (P< 0.001). [34] Abametapir (Xeglyze) is a topical 0.74% lotion indicated as a single 10-minute treatment for head lice in patients aged 6 months and older. It acts by inhibiting metalloproteinase, which is critical to egg development and survival of lice.Two studies (n=704) showed that 81.5% of abametapir treated individuals were free of lice 2 weeks after a single application compared with 49.1% treated with vehicle (P < 0.001). [59] Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64% for vehicle. Accounting for pretreatment hatch rates, the absolute
                            18
                            2014eMedicine.com
                            abametapir lotion, 0.74%, for the treatment of head louse infestation. Pediatr Dermatol. 2018 Sep. 35 (5):616-621. [QxMD MEDLINE Link]. [Full Text]. 60. Burgess IF, Lee PN, Matlock G. Randomised, controlled, assessor blind trial comparing 4% dimeticone lotion with 0.5% malathion liquid for head louse infestation. PLoS One. 2007 Nov 7. 2(11):e1127. [QxMD MEDLINE Link]. [Full Text]. 61 . Bowles VM, Hanegraaf S, Ahveninen T, Sidgiddi S, Allenby K, Alsop H. Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study. Glob Pediatr Health. 2019. 6:2333794X19831295. [QxMD MEDLINE Link]. [Full Text]. Media Gallery * * * Nit on a hair. Note the thin, translucent cement surrounding the hair shaft. Photo courtesy of David Shum, MD
                            19
                            that spinosad was more efficacious in clearing head lice than permethrin (P< 0.001). [34] Abametapir (Xeglyze) is a topical 0.74% lotion indicated as a single 10-minute treatment for head lice in patients aged 6 months and older. It acts by inhibiting metalloproteinase, which is critical to egg development and survival of lice.Two studies (n=704) showed that 81.5% of abametapir treated individuals were free of lice 2 weeks after a single application compared with 49.1% treated with vehicle (P < 0.001). [59] Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64% for vehicle. Accounting for pretreatment hatch rates, the absolute
                            20
                            that spinosad was more efficacious in clearing head lice than permethrin (P< 0.001). [34] Abametapir (Xeglyze) is a topical 0.74% lotion indicated as a single 10-minute treatment for head lice in patients aged 6 months and older. It acts by inhibiting metalloproteinase, which is critical to egg development and survival of lice.Two studies (n=704) showed that 81.5% of abametapir treated individuals were free of lice 2 weeks after a single application compared with 49.1% treated with vehicle (P < 0.001). [59] Ovicidal efficacy was measured by recording the hatch rate of eggs collected from each subject’s hair before and after treatment and incubated for 14 days. With abametapir, 100% of treated eggs remained unhatched compared with 64% for vehicle. Accounting for pretreatment hatch rates, the absolute