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:4/23/2014)... Ritalin, may prevent the depletion of self-control, according to ... of the Association for Psychological Science. , Self-control can ... to focus attention on a boring textbook are hard ... for this difficulty: Exerting self-control for a long period ... on subsequent tasks. , "It is as if self-control ...
(Date:4/22/2014)... New Jersey Institute of Technology (NJIT) today to ... launch of the New Jersey Innovation Institute (NJII), ... for business innovation through the leveraging of industry, ... Senator Cory Booker, Panasonic Corp. of North America ... Governor Kim Guadagno, New Jersey Secretary of Higher ...
(Date:4/22/2014)... DALLAS April 22, 2014 Researchers at UT ... people suffering from depression . , A ... major mechanism by which ghrelin (a hormone with natural ... identified a potentially powerful new treatment for depression in ... , The study, published online in April,s ...
(Date:4/22/2014)... Washington, DC (April 22, 2014) The International ... May 22-26 in Seattle, Washington. The theme of ... life" means in a networked and digital society. ... and attended by over 2,200 Communication scholars representing ... largest scholarly international communication conference in the world. ...
(Date:4/22/2014)... 2014. The latest scientific advances and emerging therapies in ... the main annual meeting of the Heart Failure Association ... will also hear breaking news on acute heart failure ... which is part of the main congress. , The ... at the Megaron Athens International Conference Centre (MAICC). The ...
Breaking Medicine News(10 mins):Health News:ADHD drug may help preserve our self-control resources 2Health News:Government and industry leaders herald launch of NJIT's New Jersey Innovation Institute 2Health News:Depressed? Researchers identify new anti-depressant mechanisms, therapeutic approaches 2Health News:Depressed? Researchers identify new anti-depressant mechanisms, therapeutic approaches 3Health News:International Communication Association to hold Annual Conference in Seattle, Washington 2Health News:The world's largest heart failure congress 2Health News:The world's largest heart failure congress 3
(Date:1/14/2014)... 14, 2014 NineSigma , Inc., the leading ... Innovation Leadership Summit , May 14-16, 2014 at the ... Ohio . This is the ... to breakthrough achievements through open innovation. Participants will learn ...
(Date:1/14/2014)... York , January 14, 2014 ... System Transfer Devices (CSTD) for hazardous drugs, today announced that ... the fourth straight year.   Equashield,s ... pharmacy technicians, pharmacists, nurses and other medical professionals ...
(Date:1/14/2014)... 2014 Spark Therapeutics , a late-stage gene therapy company, ... program, a Phase 3 study for inherited retinal dystrophies caused by ... D. Marrazzo , is presenting this and other corporate updates today, ... San Francisco . Marrazzo said Spark was able to achieve ...
Breaking Medicine Technology:Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 2Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 3Expect the Unexpected from Leading Global Innovators at NineSigma Leadership Summit, Sharing Winning Strategies to Advance Innovation 4Equashield's Sales Grow by 60% in 2013 2Spark Therapeutics Achieves Recruitment Goal in Phase 3 Gene Therapy Clinical Study for Inherited Blindness 2Spark Therapeutics Achieves Recruitment Goal in Phase 3 Gene Therapy Clinical Study for Inherited Blindness 3
Cached News: