Navigation Links
Topaz Pharmaceuticals Announces Completion of Pivotal Phase 3 Trials of Ivermectin Topical Cream
Date:12/7/2010

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 www.topazpharma.com.

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, www.pnas.org/cgi/doi/10.1073/pnas.1011983107.(2) 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: http://www.cdc.gov/lice/head/factsheet.html. 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:
*Name:
*Comment:
*Email:
(Date:6/8/2017)... , June 8, 2017  Less than a ... hit more than 200,000 companies, including hospital networks, in ... heralded as one of the largest online extortion attempts ... the healthcare market, it is imperative that providers understand ... their data from this — and many other very ...
(Date:6/7/2017)... 6, 2017  Diplomat Specialty Infusion Group, a brand of Diplomat ... its Iowa location. The ... now features an ISO 7 cleanroom—the standard needed to compound intravenous ... low level of pollutants. "Our ... and better serve our Iowa patients," said ...
(Date:6/1/2017)... BELL, Pa. , June 1, 2017 ... (PRN) and Veterinarian Recommended Solutions (VRS), and KD Pharma ... investment in Nutriceutical Holdings by KD Pharma Group. KD ... Holdings with the option to acquire the entire company. ... partner in KD. They are committed to growing the ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and ... has selected 21 leaders from government, business and civil society in 11 countries across ... U.S. this fall, engaging in a transformative exchange of knowledge and ideas with the ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ross Insurance ... With the Federal Emergency Management Agency’s (FEMA) recent update of flood zones, more ... 2012, the Biggert-Waters Act was enacted to reflect the actual risk in flood ...
(Date:6/23/2017)... ... June 23, 2017 , ... The Katyl Agency, ... to families and business owners in and around Lackawanna County, is joining Meals ... in the area. , Meals on Wheels of NEPA provides hand-delivered and nutritious ...
(Date:6/23/2017)... ... June 23, 2017 , ... Radabaugh & Associates, a locally ... business owners in North Central West Virginia, is embarking on a cooperative charity ... residents in the region. , The Stepping Stones organization offers a series of ...
(Date:6/22/2017)... ... June 22, 2017 , ... Plastic Surgery Associates is proud to report ... 2017. Each year, research and information firm, Castle Connolly, releases their list of the ... this marks the 3rd time that Dr. Canales has been recognized by ...
Breaking Medicine News(10 mins):