Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Ferrer Submits IND for Arasertaconazole Nitrate

Published: Tuesday, January 01, 2013
Last Updated: Monday, December 31, 2012
Bookmark and Share
Phase III studies in VVC for the patented, best-in-class topical azole will be initiated at the beginning of 2013, subject to regulatory approval.

Ferrer has announced that it has filed an IND for its topical antifungal agent Arasertaconazole nitrate.

The agent has recently demonstrated rapid symptomatic relief and significant clinical and mycological benefits after a single administration delivered as a vaginal suppository (pessary) formulation in a multicentre Phase II study in patients with VulvoVaginal Candidiasis (VVC).

VVC, or vaginal thrush as it is also known, is a common infection affecting 70 - 75 per cent of women at least once in their lives. The worldwide market for gynaecological antifungal products exceeds USD 600 million per annum.

Arasertaconazole is a new, fast-acting topical antifungal. The agent has a broad spectrum of activity against Candida spp involved in VVC, including species described as resistant to fluconazole.

It is the active, patented, R-enantiomer of sertaconazole nitrate, itself an antifungal agent developed by Ferrer and marketed for more than 20 years in more than 70 countries.

Formulated as a vaginal suppository (pessary), Arasertaconazole has demonstrated very low systemic exposure, a good safety profile and was well tolerated in clinical studies involving 283 female subjects to date.

In the multicentre Phase II dose-ranging study involving 229 female patients with VVC, Arasertaconazole formulated as a vaginal suppository (pessary) demonstrated both fast-acting (superiority to placebo at 8 plus/minus 2 days of treatment) and prolonged (up to at least 26 plus/minus 4 days) clinical and mycological efficacy at all doses tested (150mg, 300mg, 600mg).

The therapeutic response to Arasertaconazole was dose-dependent, with the 600mg dose most efficacious.

Moreover, Arasertaconazole showed evidence of rapid relief from additional clinical symptoms (at less than 2 days, e.g. irritation and itching) when compared to placebo. Arasertaconazole was both safe and well tolerated in this study.

"VulvoVaginal Candidiasis (VVC) due to Candida spp infections remains a common problem worldwide, especially in women of childbearing age. The emergence of both treatment resistant Candida species and new pathogenic strains are considered some of the reasons for the underserved medical needs in this condition," said Antonio Guglietta, R&D Director at Ferrer.

Guglietta continued, "Following discussions with the regulators, Ferrer will initiate Phase III clinical studies that will further differentiate Arasertaconazole as a safer, fast-acting antifungal treatment for VVC in women aged more than 12 years old."

Ferrer is currently assessing alternative formulations for Arasertaconazole as treatments for other topical fungal infections that include tinea pedis (athlete's foot).

Arasertaconazole, as well as the vaginal suppository (pessary) formulation, is the subject of granted and pending patent applications and is available for further development and commercialization worldwide from Ferrer.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Making It Personal
Cancer vaccine linked to increased immune response against leukemia cells.
Gene Therapy Maintains Clotting Factor for Hemophilia Patients
Following a single gene therapy dose, the highest levels of an essential blood clotting factor IX were observed in hemophilia B patients.
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Study to Assess Shorter-Duration Antibiotics in Children
Physicians plan a clinical trial to evaluate whether short course anti-biotics are effective at treating CAP in children.
Cancer Gene Predicts Treatment Response in Leukaemia
Study indicates the patients suffering from a lethal for of acute myeloid leukemia may live longer when receiving milder chemotherapy drugs.
Injectable Biologic Therapy Reduces Triglycerides
Study finds first-of-its-kind therapy promising for patients with high triglycerides, cholesterol.
Testing Zika Vaccine in Humans Begins
The first of five planned clinical trials to test ZPIV vaccine in humans has begun.
Combination Therapy Improved Chemoresistance in Ovarian Cancer
The study demonstrates how an existing class of targeted therapies could be used to potentiate the tumor suppression induced by cisplatin.
Gene Therapy for Blistering Skin Disease Shows Promise
Grafting genetically altered skin onto patients’ chronic wounds marks the first time skin-based gene therapy has been demonstrated to be safe and effective in humans.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!