Navigation Links
Topaz Pharmaceuticals Announces Completion of Pivotal Phase 3 Trials of Ivermectin Topical Cream

HORSHAM, Pa., Dec. 7, 2010 /PRNewswire/ -- Topaz Pharmaceuticals Inc., a privately held specialty pharmaceutical company, today announced the completion of two Phase 3 clinical trials that studied the use of ivermectin topical cream as a potential treatment for head lice. These trials were conducted according to a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA).

"Parents and caregivers are looking for safe and effective treatments for head lice," said Thomas Beck, MD, Chief Medical Officer at Topaz.  "Current treatment options are limited by safety, efficacy and convenience issues.  We believe there is an unmet need to provide a new option for the more than six million people, mostly school aged children who are impacted by lice each year in the US.  The completion of our two Phase 3 clinical trials is a critical milestone in our development of ivermectin topical cream as a potential head lice treatment and for Topaz, as we continue to move closer to realizing our vision of being a commercial-stage company."

Topaz plans to submit its new drug application (NDA) to the FDA in 2011.

About the Phase 3 Ivermectin Cream ProgramMore than 600 patients participated in the two randomized Phase 3 ivermectin topical cream studies sponsored by Topaz.  These studies compared 0.5% ivermectin cream with a vehicle control (placebo).  Either ivermectin topical cream or placebo was dispensed to clinical trial participants six months of age and older for application to dry hair and scalp.  The primary efficacy endpoint for these studies was achieving "lice free" status within approximately 24 hours of application and maintaining this status for at least 14 days after application.  Patients were also evaluated for safety and local tolerability.  These studies were conducted in follow-up to favorable Phase 2 clinical studies that were presented by researchers in July 2010 at the Society for Pediatric Dermatology annual meeting.

About IvermectinIvermectin is a broad-spectrum antiparasitic agent.  Its antiparasitic mechanism of action is through binding selectively to certain ion channels present in invertebrate nerve and muscle cells but not present in mammals. The resulting increase in permeability of the cell membrane causes the death of certain parasites.  First developed from a soil bacterium, widespread oral use of ivermectin, under the brand name Mectizan®, began in 1987 in sub-Saharan Africa to control onchocerciasis (river blindness) in humans.  As of 2009, over 800 million doses of oral ivermectin had been administered as part of a river blindness eradication program.(1)  A novel topical form of ivermectin is currently under clinical investigation by Topaz as a potential therapy to treat head lice.

Impact of Head LiceHead lice infestation is a common affliction that occurs throughout the world.(2,3)  It is estimated that 6-12 million infestations occur each year in the United States, with infestations typically affecting children between the ages of three and 11.(4)   The social and economic burden of head lice can be significant,(5,6,7) and may lead to social ostracism, cause parental anxiety and act as a source of economic loss through missed school days and caregiver time off work.  Children found to be infested with head lice may not be allowed to return to school due to local no-nit policies.(8)  Despite parents' best efforts to get rid of lice, current treatments are often ineffective, and safety and convenience issues have been associated with the available prescription treatments.

About Topaz PharmaceuticalsTopaz Pharmaceuticals Inc. is a privately held specialty pharmaceutical company developing innovative treatments for the adult and pediatric markets. The company's lead investigational product is a topical cream formulation of ivermectin, under development for the treatment of head lice. The company has recently concluded two Phase 3 studies of ivermectin for this potential indication. For more information about Topaz Pharmaceuticals Inc., please visit

Mectizan® is a registered trademark of Merck & Company(1) Moreno Y, Nabhan JF, Solomon J, Mackenzie CD, Geary TG.  Ivermectin disrupts the function of the excretory-secretory apparatus in microfilariae of Brugia malayi. Proceedings of the National Academy of Science, 2010; Published on line, Burkhart CG. Relationship of treatment-resistant head lice to the safety and efficacy of pediculicides. Mayo Clinic Proc. 2004;79:661-666.(3) Falagas ME, Matthaiou DK, Rafailidis PI, et al. Worldwide prevalence of head lice. Emerg Infect Dis. 2008;14:1493-1494. (4) CDC. Centers for Disease Control and Prevention. Head lice fact sheet. Available at: Accessed October 6, 2009.(5) Gordon S. Shared vulnerability: A theory of caring for children with persistent head lice. J School Nursing. 2007;23(5):283-292.(6) Gur I, Schneeweiss R. Head lice treatments and school policies in the US in an era of emerging resistance: A cost-effectiveness analysis. Pharmacoeconomics.2009;27(9):725-734.(7) Hansen R, O'Haver J. Economic considerations associated with Pediculus humanus capitis infestation. Clin Pediatr. 2004; 43:523.(8) Mumcuoglu KY, Meinking TA, Burkhart CN, Burkhart CG. Head louse infestations: the "no nit" policy and its consequences. Int J Dermatol. 2006;45:891–896.

SOURCE Topaz Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Topaz Pharmaceuticals Names Bob Radie Chief Executive Officer
2. TOPAZ Technologies and ML Weekes & Company Announce Partnership
3. Shareholder Class Action Filed Against SciClone Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP
4. Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology
5. TOPAZ Technologies and Tecniplast USA Launch RFID Mobile Census
6. Shareholder Class Action Filed Against Rigel Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP
7. Shareholder Class Action Filed Against Vertex Pharmaceuticals Incorporated by the Law Firm of Schiffrin Barroway Topaz & Kessler, LLP
8. Schiffrin Barroway Topaz & Kessler, LLP and Janet Jenner & Suggs, LLC Comment on Conagra Advisory Regarding Pot Pies Linked to Salmonella Outbreak
9. HemaQuest Pharmaceuticals, Inc. Presents Promising Clinical Results at 52nd Annual Meeting of the American Society of Hematology (ASH)
10. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
11. Portola Pharmaceuticals Announces Data Presentations Highlighting Syk/JAK Inhibitor Clinical Development Program at 52nd American Society of Hematology Annual Meeting
Post Your Comments:
(Date:11/26/2015)... SAN FRANCISCO , November 26, 2015 ... 1.82 billion by 2022, according to a new report by ... as Chronic Kidney Disease (CKD) which demands kidney transplantation is ... convenient and cost effective substitute for organ transplantation. --> ... 1.82 billion by 2022, according to a new report by ...
(Date:11/26/2015)... 26, 2015 ... of the  "2016 Future Horizons and ... Surface Testing Market: Supplier Shares, Competitive ... offering.  --> ) ... "2016 Future Horizons and Growth Strategies ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and Markets ... "Advanced Wound Care Market by Type (Dressings, Therapy ... User (In-Patient Facility, Out-Patient Facility), and Geography - Global ... --> --> The ... definition and forecast of the global advanced wound care ...
Breaking Medicine Technology:
(Date:11/25/2015)... , ... November 25, 2015 , ... Dental professionals who ... Cleveland, OH , are invited to attend Dr. Mark Iacobelli’s Advanced Implant Mentoring (AIM) ... in Cleveland, OH. , As the co-founders of Advanced Implant Mentoring (AIM), Dr. ...
(Date:11/25/2015)... IL (PRWEB) , ... November 25, 2015 , ... The ... announce a recent successful appellate decision obtained by Attorneys Francisco J. Botto and Alex ... Adcock v. Illinois Workers’ Compensation Comm’n, 2015 IL App (2d) 130884WC. , According to ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... a double board certified facial plastic surgeon specializing in both surgical and non-surgical ... of The Skin Spa at Hobgood Facial Plastic Surgery. , Highly trained ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study ... (RMC) in Chicago, IL, UV Angel is evaluating the efficacy of its product and ... care units (totaling 30 beds) from May 2014 through October 2015 at a 360-bed, ...
(Date:11/25/2015)... Missouri (PRWEB) , ... November 25, 2015 , ... ... HEAL, will provide scholarships for people struggling with eating disorders as a result ... from the second annual event, held at Fox Run Golf Club in Eureka, ...
Breaking Medicine News(10 mins):