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:


(Date:6/26/2016)... ... ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a weight ... app plans to fix the two major problems leading the fitness industry today:, ... program , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June ... , brings up a new, often overlooked aspect of head lice: the parasite’s ability to ... is not a common occurrence, but a necessary one in the event that lice have ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the ... Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , “We ... new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016 The Academy ... of recommendations that would allow biopharmaceutical companies ... with entities that make formulary and coverage decisions, a ... "value" of new medicines. The recommendations address ... not appear on the drug label, a prohibition that ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June ... -based mobile pulmonary function testing company, is now able to ... devices developed by ndd Medical Technologies , Inc. ... done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ... , can get any needed testing done in the comfort of ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
Breaking Medicine Technology:
Cached News: