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:4/28/2015)... 28, 2015 PFC Fitness Camp, the ... La Costa Resort and Spa partners with MD Revolution ... loss and overall health at home. Utilizing wearable fitness ... PFC RevUp ensures the healthy habits and results achieved ... life kick in and  clients are left to their own devices. , ...
(Date:4/28/2015)... Two leaders in patient safety from the ... Hospital Review’s list of 50 Experts Leading the Field ... , director of the Armstrong Institute for Patient ... patient safety and quality at Johns Hopkins Medicine, and ... medical affairs and chief patient safety officer at All ...
(Date:4/28/2015)... The biologics safety testing market is ... the market include growth of the pharmaceutical and biological ... Over the years, the number of drug approvals in ... the FDA approved 225 drug applications and Health Canada ... for 3,822 of the pharmaceutical and 1,998 of the ...
(Date:4/28/2015)... Kansas City, Missouri (PRWEB) April 28, 2015 ... dedicated exclusively to healthcare executive search, announced today that ... Vice President & Chief Operating Officer search for ... Hawaii. . , Reporting to QHS President & ... Chief Operating Officer will have operating responsibility for the ...
(Date:4/28/2015)... A new survey from National Stroke Association ... of Americans fear brain damage the most. The results, ... shed light on the need for greater awareness of the ... By controlling modifiable risk factors, 80 percent of strokes ... brain attack ” that occurs when blood flow to the ...
Breaking Medicine News(10 mins):Health News:PFC Fitness Camp Launches Bullet-Proof Accountability Platform for Sustained Weight Loss At Home 2Health News:PFC Fitness Camp Launches Bullet-Proof Accountability Platform for Sustained Weight Loss At Home 3Health News:Johns Hopkins Medicine and All Children’s Hospital Leaders Recognized as Top Experts in Patient Safety 2Health News:Johns Hopkins Medicine and All Children’s Hospital Leaders Recognized as Top Experts in Patient Safety 3Health News:Johns Hopkins Medicine and All Children’s Hospital Leaders Recognized as Top Experts in Patient Safety 4Health News:Biological Safety Testing Market, By Application Product & Test – Global Forecast 2019 - Report Released by MarketsandMarkets 2Health News:Biological Safety Testing Market, By Application Product & Test – Global Forecast 2019 - Report Released by MarketsandMarkets 3Health News:Biological Safety Testing Market, By Application Product & Test – Global Forecast 2019 - Report Released by MarketsandMarkets 4Health News:The Queen’s Health Systems Retains MSA Executive Search to Recruit Executive Vice President & Chief Operating Officer 2Health News:National Stroke Association Survey Reveals Americans Fear Brain Damage the Most, but Few Take the Necessary Steps to Prevent a Stroke 2Health News:National Stroke Association Survey Reveals Americans Fear Brain Damage the Most, but Few Take the Necessary Steps to Prevent a Stroke 3
(Date:4/28/2015)... SAN ANTONIO , April 28, 2015 /PRNewswire/ ... that the U.S. Patent and Trademark Office has ... GenSpera,s intellectual property portfolio claiming numerous compositions for ... Prostate Specific Antigen (PSA).  GenSpera ... specific peptides with a powerful cytotoxin isolated from ...
(Date:4/28/2015)... 2015 /CNW/ - The group representing the living victims of ... a two-hour meeting with Health Canada officials in a ... Canada announced a $180 million support package for Thalidomide ... after the Health Canada announcement and five months after ... victims, the group representing Canada,s ...
(Date:4/28/2015)... April 28, 2015 Anteo Technologies is ... new tools developed with their patented Mix&Go™ Activation ... methods, helping to improve medical devices and in-vitro ... Increasingly complex multifactorial diagnosis of cancer and ... It is restricted to measure only a ...
Breaking Medicine Technology:GenSpera Granted New Patent for Prodrugs Activated by Prostate Specific Antigen 2Thalidomide Victims Gravely Concerned by Health Canada's Silence 2Faster Detection of Disease: Anteo is Transforming The Way Scientists Work with Luminex(R) xMAP(R) 2Faster Detection of Disease: Anteo is Transforming The Way Scientists Work with Luminex(R) xMAP(R) 3
Cached News: