HOME >> MEDICINE >> NEWS
Positive results for ACRUX's lead product in US Phase 3 trial

Acrux (ASX: ACR), the pharmaceutical company with unique technology for delivering drugs through the skin, today announced positive results in a US Phase 3 clinical trial of Evamist, its daily skin spray for prevention of symptoms associated with menopause. The trial was conducted by its US commercial partner VIVUS Inc. (NASDAQ: VVUS), which will now proceed to file a marketing application with the US Food and Drug Administration (FDA) in the second half of 2006.

Evamist is the most advanced commercial application of Acrux's patented delivery technology; if the FDA approves VIVUS' marketing application, Acrux's first product could be available to women in the USA in the second half of 2007. Several other products that use the same delivery technology are following close behind. The positive result of this Phase 3 trial is therefore a pivotal milestone for each of these products.

The Phase 3 trial assessed the safety and efficacy of Evamist for the treatment of hot flushes in menopausal women. The trial was a 12-week study of 457 menopausal women, conducted under a Special Protocol Assessment (SPA) from the FDA. Results showed that the most effective Evamist dose decreased the number of hot flushes by 78%. The reduction in frequency and severity of moderate to severe hot flushes was statistically significant compared with placebo for all three doses of Evamist evaluated.

Importantly, application site irritation was less than 1% and was mild in nature. The results from the trial will be discussed by VIVUS at an Analyst Day in New York on 18 May 2006.

"We believe these positive trial results along with this novel patient-preferred transdermal delivery system will establish Evamist as a superior estrogen therapy for the treatment of menopausal symptoms," stated Leland Wilson, president and chief executive officer for VIVUS. "We have worked diligently toward the development of this unique and easy-to-use product, and we are thrilled with
'"/>

Contact: Igor Gonda
61-38-379-0100
Research Australia
9-May-2006


Page: 1 2

Related medicine news :

1. Positive results more likely from industry-funded breast cancer trials
2. M. D. Anderson reports first drug activity in T315I-Positive CML, ALL and JAK-2-Positive MPD
3. Positive parenting helps encourage healthy sun habits in children
4. Positive outcome of Medicare drug benefit
5. Positive study results for methylphenidate transdermal system
6. Positive study results for methylphenidate transdermal system
7. Stem cell transplantation procedure results in long-term survival for amyloidosis patients
8. GSKs Pazopanib shows positive results in patients with advanced renal cell carcinoma
9. GSKs Pazopanib shows positive results in patients with advanced RCC and ovarian cancer
10. Targeted, oral agent Enzastaurin shows favorable results
11. Childhood obesity intervention shows promising results

Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Positive results for ACRUX lead product Phase trial

(Date:10/22/2014)... On Saturday, October 25, 2014, the Brownsville Community Health ... fitness fair ¡Vive tu vida! Get Up! Get Moving!®. The ... better health and wellness for people of all ages and ... the public, will be held at Dean Porter Park, 501 ... pm. , “¡Vive tu Vida! Get Up! Get Moving!® ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 ... staffing company, is happy to announce that our ... to Staffing Industry Analysts’ Staffing 100 for 2014. ... the “100 most influential people in the staffing ... Medical Solutions, the 13th-largest healthcare staffing company in ...
(Date:10/22/2014)... For Dr. Iris Hunter, a job is more than just ... life’s mission. Her extensive experience in the nonprofit sector, coupled ... make it clear that Hunter’s mission is to serve others. ... a difference in the lives of others,” Hunter said. “Additionally, ... I felt ready to start on this journey as a ...
(Date:10/22/2014)... TUESDAY, Oct. 21, 2014 (HealthDay News) -- The ... passengers arriving from Ebola-affected nations of West Africa ... screen them for infection with the virus. ... Jeh Johnson noted that 94 percent of air ... land at one of these five airports -- ...
(Date:10/22/2014)... October 22, 2014 The ... which is dedicated to distribute health information technology ... delivery worldwide announced the development of six key ... expect when receiving healthcare. These are an expansion ... care: “providing care that is respectful of and ...
Breaking Medicine News(10 mins):Health News:Brownsville Community Health Center Presents Fourth Annual ¡Vive Tu Vida! Get Up! Get Moving!® Event 2Health News:Brownsville Community Health Center Presents Fourth Annual ¡Vive Tu Vida! Get Up! Get Moving!® Event 3Health News:Brownsville Community Health Center Presents Fourth Annual ¡Vive Tu Vida! Get Up! Get Moving!® Event 4Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 3Health News:Dr. Iris Hunter to Host Grand Opening of FirstLight HomeCare Tomorrow 2Health News:Passengers From Ebola-Affected Countries Must Land at Designated U.S. Airports 2Health News:Passengers From Ebola-Affected Countries Must Land at Designated U.S. Airports 3Health News:The Sullivan Institute for Healthcare Innovation Announces Release of Guiding Principles for Patient Experience-Centered Care 2
(Date:10/22/2014)... HAMILTON, N.J. , Oct. 22, 2014 ... CLIA-certified, CAP-accredited laboratory which specializes in high ... that it is now offering new Cystic ... including next- generation DNA sequencing platforms. ... a genetically inherited multisystem disorder that affects ...
(Date:10/22/2014)... , Oct 22, 2014 Antigen Discovery ... Irvine, California , announced the receipt of a ... Innovation Research award (SBIR) from the National Institute of Dental and ... the development of a Pan-HIV Protein Microarray Chip, which ... and HIV-2 subtypes and aid in the development of ...
(Date:10/22/2014)... AVACEN Medical announced today that its AVACEN ... clearance by the U.S. Food and Drug Administration. This ... the Internet for: the temporary relief of joint ... and sprains . Logo - http://photos.prnewswire.com/prnh/20141021/153513 ... is a sophisticated medical device incorporating over 3,000 firmware ...
Breaking Medicine Technology:Medical Diagnostic Laboratories, L.L.C. Institute for Biomarker Research Announces New Prenatal Cystic Fibrosis Tests 2Biomarker Discovery Company, Antigen Discovery Inc., Awarded an NIH Phase I Small Business Innovation Research Grant to Develop a Pan-HIV Protein Microarray Chip 2AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2
Cached News: