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:5/27/2017)... ... ... dentist? You should go twice per year for checkups, but if you want to keep ... some dental tips to help out: , 1. Brushing Teeth - Brush your teeth twice ... locker at school for a quick brushing after lunch. Use a small brush head with ...
(Date:5/26/2017)... ... , ... Mediaplanet is proud to announce the launch of its newest edition ... readers on how to take care of all aspects of their skin. , On ... Dancing with the Stars professional, Witney Carson, shares her journey with the disease that ...
(Date:5/26/2017)... ... ... Amir Qureshi, MD is the first physician in Arkansas to implant Nuvecta’s ... Nuvectra™ Algovita SCS System has been FDA approved as a treatment option for chronic ... introduce the most powerful SCS system and the only stretchable lead on the market. ...
(Date:5/26/2017)... ... 26, 2017 , ... via seating is proud to partner ... chair specifically designed for clinical areas. Genie Copper Mesh is a crossover chair ... to provide customers with a game changing chair that is affordably priced,” Chas ...
(Date:5/26/2017)... ... ... Silver Birch of Hammond, a new assisted lifestyle community, has welcomed its first ... at 5620 Sohl Avenue in Hammond, serves older adults who need some help to ... apartments. Each of the private apartments at Silver Birch features a kitchenette, spacious bathroom ...
Breaking Medicine News(10 mins):
(Date:5/10/2017)... 2017 Radiology has become the number one ... also spiraled to the number one ranking as a ... ever before as the most complete and reliable method ... lower back pain an MRI may confirm a suspected ... resulting in entirely different treatment protocols.  In these circumstances, ...
(Date:5/9/2017)... 2017  Oramed Pharmaceuticals Inc. (NASDAQ: ... company focused on the development of oral drug ... Property Office has granted Oramed a patent titled, ... The patent covers Oramed,s invention of an oral ... an incretin hormone that stimulates the secretion of ...
(Date:5/6/2017)... May 5, 2017   Provista , a proven leader ... 200,000 customers, today announced Jim Cunniff as the ... executive and business experience to Provista, including most recently serving ... California . He assumed his new role ... a great fit for Provista," says Jody Hatcher , ...
Breaking Medicine Technology:
Cached News: