Navigation Links
Strativa Pharmaceuticals' Development Partner, BioAlliance Pharma, Presents Phase III Study Results of Miconazole Lauriad(R) for the Treatment of Oropharyngeal Candidiasis
Date:9/14/2009

WOODCLIFF LAKE, N.J., Sept. 14 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced that its development partner BioAlliance Pharma SA presented Phase III study results for miconazole Lauriad(R) mucoadhesive buccal tablets (MBT) that demonstrate noninferiority to clotrimazole troches for oropharyngeal candidiasis (OPC), an opportunistic infection of the mouth and throat. The data from this study, the largest study to date conducted in OPC, were presented in an oral presentation to attendees at the 49th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco. More than 10,000 physicians, researchers and other healthcare professionals from around the globe gather each year at ICAAC to foster worldwide solutions to the problem of infectious diseases.

The randomized, double-blind, double-dummy study compared the efficacy and safety of once-daily miconazole 50 mg MBT to clotrimazole 10 mg troche administered five times per day for treatment of OPC. Results showed no significant differences between miconazole MBT and clotrimazole troches in any of the clinical efficacy endpoints, including the primary endpoint of complete resolution of signs and symptoms of OPC. The study was conducted in 577 HIV/AIDS patients in 40 sites in the United States, Canada and South Africa.

Miconazole MBT -- which delivers the antifungal miconazole via a mucoadhesive buccal tablet designed to enable once-daily dosing of the active ingredient at the site of infection -- is currently undergoing review by the U.S. Food and Drug Administration (FDA). If approved, Strativa, the exclusive U.S. distributor of miconazole MBT under a licensing agreement with BioAlliance Pharma SA, could make miconazole MBT available in the U.S. in the second half of 2010. While approved in 12 countries and marketed in several EU territories under the trade name Loramyc(R), miconazole MBT would be the first miconazole oral therapy available in the U.S.

"We believe that if approved, miconazole MBT will represent an important new treatment option for immunocompromised patients and others who suffer from OPC," said John A. MacPhee, president of Strativa Pharmaceuticals. "Miconazole MBT supports our commitment to providing innovative prescription medicines that help manage complications from serious medical conditions, across a variety of therapeutic areas."

OPC, also known as thrush, is an oral fungal infection most common in individuals with weakened immune systems -- particularly those with HIV/AIDS and those undergoing cancer treatments. OPC is a disruptive condition that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, burning and/or altered taste.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch. For additional information, please visit www.strativapharma.com.

About Par Pharmaceutical

Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.

About BioAlliance Pharma

BioAlliance Pharma SA is a specialty pharmaceutical company focused on the treatment of opportunistic infections in cancer and HIV. The Company develops and commercializes innovative products that address resistance issues. For press release and other company information, visit www.bioalliancepharma.com.

Safe Harbor Statement

Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in Item 1A of the Company's subsequent Quarterly Reports on Form 10-Q, in other of the Company's filings with the SEC from time to time, including Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.


'/>"/>
SOURCE Par Pharmaceutical Companies, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Strativa Pharmaceuticals Provides Product Pipeline Update
2. Strativa Pharmaceuticals Announces Preliminary Results from ONCONASE(R) Phase IIIb Clinical Trial
3. Strativa Pharmaceuticals Announces Phase III Results for Loramyc(R) to Treat Oropharyngeal Candidiasis
4. Keryx Biopharmaceuticals Phase 2 Data of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Renal Cell Cancer Selected for Oral Presentation at the Eighth International Kidney Cancer Symposium
5. In Vitro Study of Adamas Pharmaceuticals Triple Combination Antiviral Drug Therapy Shows Activity Against Drug-Resistant Influenza Viruses
6. MAP Pharmaceuticals Analysis of Positive Phase 3 LEVADEX(TM) Data To Be Presented in Late-Breaking Session at 14th Congress of the International Headache Society
7. Anadys Pharmaceuticals Commences Dosing in Phase II Study of ANA598
8. ISTA Pharmaceuticals Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
9. ISTA Pharmaceuticals Announces Preliminary Results of T-Pred Studies
10. LigoCyte Pharmaceuticals Initiates a Randomized, Double Blind, Placebo Controlled Norovirus Vaccine Study Including Live Virus Challenge
11. Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Research and Markets has announced the addition of the ... ... capillary electrophoresis market to grow at a CAGR of 7.06% during ... Market 2017-2021, has been prepared based on an in-depth market analysis ... and its growth prospects over the coming years. The report also ...
(Date:3/23/2017)... Newborns are highly vulnerable to infections ... their young immune systems typically mount weak antibody ... achieving strong vaccine responses in newborn animals, including ... trials — by adding compounds known as adjuvants ... papers, they also describe improved adjuvant formulations that ...
(Date:3/23/2017)... , March 23, 2017 ... from the TACTI-mel trial of IMP321 in combination with ... the first (1mg/kg) cohort experiencing a complete response. Recruitment ... cohort is expected to be fully recruited by Q317. ... the AIPAC breast cancer study are expected mid-year (recruitment ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... 2017 , ... Empower Brokerage, located in Southlake, Texas, intends ... , In February, 2017, Empower Brokerage introduced their new “Performance Partners” program to ... teach how to maximize their sales efforts, as well as how to best ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... stories about real people of God in congregations across the United States. ... Presbyterian minister ordained in 1964 who has served congregations in seven states throughout ...
(Date:3/23/2017)... ... 23, 2017 , ... Demonstrating their commitment to improving health ... departments have been awarded national accreditation through the Public Health Accreditation Board ... network of communities across the nation whose health departments meet rigorous national standards ...
(Date:3/23/2017)... NY (PRWEB) , ... March 23, 2017 , ... 82% of adults are unaware of ... kids do not brush their teeth the minimum two times a day that dentists recommend. ... students missing 51 million hours of school and adults missing 164 million hours of work ...
(Date:3/23/2017)... (PRWEB) , ... March 23, 2017 , ... ... investment in Los Angeles based healthcare technology company California Healthcom Group (CHG). ... the US, and healthcare arena. With headquarters in California, CHG is a growing, ...
Breaking Medicine News(10 mins):