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
'/>"/>

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

Page: 1 2 3

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:7/11/2014)... , July 11, 2014  Veran ... company, announced today the positive, cost-effective final ... innovative SPiNPerc™ procedure. The SPiNPerc endobronchial percutaneous ... a percutaneous approach to biopsy when a ... patients and physicians experience positive financial outcomes ...
(Date:7/11/2014)... , July 11, 2014 Neurelis, Inc. ("Neurelis") ... to end the option held by Biotie to purchase ... development of NRL-1 (intranasal diazepam) for pediatric and adult ... Over the past year, Biotie has advanced the development ... for the pivotal clinical work required for NDA submission ...
(Date:7/10/2014)... , 11. Juli 2014  Dilon ... für die molekulare Bildgebung, einschließlich molekularer ... die CE-Zulassung für sein Navigator ® ... Dilon das Produkt jetzt europaweit vertreiben. ... Großteil der europäischen Länder ausgedehnt und ...
Breaking Medicine Technology:Veran Medical Publishes Lung Cancer Patient Management Study 2Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3Dilon erhält CE-Zulassung für sein Navigator-Gamma-Sondensystem 2
... Oct. 18 Findings from the PRECiSE 3 (P3) ... demonstrating the longest continuously running maintenance trial for an ... 2010 Annual Scientific Meeting of the American College of ... 15 – 20.  Additionally, long-term efficacy data from the ...
... technology world moves to Basking Ridge, NJ when " 2010 ... Agency (KOTRA), kicks off later this month. The conference is ... seeking the most innovative and creative technology in the U.S. ... EDT (US & Canada) at the Dolce Hotels and Resorts. ...
Cached Medicine Technology:UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 2UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 3UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 4UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 5UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 6UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 7UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 8UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 9UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 10UCB Presents Growing Body of Long-term Efficacy Data at ACG 2010 Meeting to Further Support Treatment with Cimzia® (certolizumab pegol) in Multiple Patient Populations with Moderate to Severe Crohn's Disease 11Top U.S. and Korean Companies to Converge at 2010 Global Partnering Day 2
(Date:7/11/2014)... MIDDLEBURY, CT (PRWEB) July 11, 2014 ... announced today the launch of the Timex Performance Network, ... product information, training plans, athlete testimonials, seasonal news and ... Performance Network will capitalize on the legacy of the ... online destination for runners and endurance athletes nationwide. The ...
(Date:7/11/2014)... 11, 2014 (HealthDay News) -- Polio is history in ... like Afghanistan, Nigeria and Pakistan. Giving vaccinated children an ... immunity and help eradicate the highly infectious disease, a ... highly effective, immunity wanes as early as a year ... infected and contribute to the spread of the disease, ...
(Date:7/11/2014)... AngelWeddingDress is now providing worldwide clients with ... ”. When it comes to buying summer wedding dresses ... the unlimited stock of beautiful wedding gowns. Recently, the ... summer wedding gowns. , The company’s current promotion ... pace with the newest fashion trends. The top experts ...
(Date:7/11/2014)... Alliance Labs announced that they will be featured ... Jr, airing later this year 2014, via Discovery Channel. ... Innovations will explore DocuSol® Kids, a mini-enema containing a ... base designed to give adolescents general constipation relief. Viewers ... hyperosmotic laxative by drawing water into the bowel from ...
(Date:7/11/2014)... July 11, 2014 Anterior Cruciate Ligament ... but the type of material used to create a ... the game, say researchers presenting their work today at ... Sports Medicine ( AOSSM ). , “Our ... allografts (tissue harvested from a donor) fail more frequently ...
Breaking Medicine News(10 mins):Health News:Timex Announces Launch of Timex Performance Network 2Health News:Researchers Assess New Way to Boost Polio Immunity 2Health News:AngelWeddingDress Will Continuously Unveil More Summer Wedding Dresses for Loyal Clients 2Health News:Alliance Labs & DocuSol® to be Featured in Upcoming Episode of Innovations 2Health News:ACL Reconstructions May Last Longer With Autografts 2
... cases from two severely disabled children. These cases were mainly ... negligent medical advice. //One such is that of Alexia Harriton, ... that her family doctor had not informed her mother about ... is that of a five-year-old Keeden Waller who was born ...
... The Australian Medical Association announced today that six doctors ... the implementation of new rosters,//which they contend could harm ... doctors are simply expressing displeasure over the new working ... the resignation of the doctors was effective from this ...
... the doctors of the Royal College of Physicians it was ... //It was found that about 73% of the doctors were ... dying where it states that the doctors should be given ... the terminally ill person. But the physicians of the ...
... Office workers are at an increased risk of being affected ... hours on their computer.// DVT is a condition that gives ... the heat or the lung with often fatal consequences. ,This ... e-thrombosis. The condition came to light after it emerged that ...
... take place on June 18 has been advanced to ... the advancement but the centre is against the advancement ... the death of about 1,000 to 2,000 lives every ... children in Muslim-dominated areas are dying. About 5.2 million ...
... from Uttar Pradesh has disproved the claims of health authorities ... been reported in the state. ,This is reported ... (NPSP) issued here this month. ,Some of the ... by the state but also by international agencies like UNICEF, ...
Cached Medicine News:Health News:Fresh Polio Cases Reported In Uttar Pradesh 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: