Navigation Links
FDA Approves Strativa Pharmaceuticals' Zuplenz® (ondansetron) Oral Soluble Film
Date:7/2/2010

WOODCLIFF LAKE, N.J., July 2 /PRNewswire/ -- Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz® (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.  Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.

The FDA approval was granted based on clinical study data comparing the bioequivalence of Zuplenz 8 mg to Zofran ODT® (orally dissolving tablet) 8 mg.  The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT.

"The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment to enhancing prescription products to meet the different needs of patients," said John A. MacPhee, President, Strativa Pharmaceuticals. "Zuplenz offers an innovative and convenient, easy-to-take formulation for patients who have trouble swallowing tablets, while providing the trusted efficacy expected from ondansetron."

Zuplenz uses proprietary PharmFilm® oral soluble film technology from MonoSol Rx to rapidly dissolve on the tongue without the need for water, which can cause additional discomfort for some patients suffering from nausea and vomiting.  Zuplenz will be offered in 4 mg and 8 mg dosage strengths, and is expected to be available in retail pharmacies in the third quarter of 2010.

Nausea and vomiting is a common side effect associated with chemotherapy, radiotherapy, and surgery. Left untreated, nausea and vomiting can have serious consequences such as exhaustion, dehydration and undernourishment, which can interfere with treatment and healing.

In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization rights to Zuplenz oral soluble film.  Under the terms of the amended agreement, the FDA approval triggered Strativa's payments to MonoSol Rx of a $4.0 million approval milestone and a $2.0 million pre-launch milestone.

Indication and Important Safety Information

Zuplenz is indicated for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

The concomitant use of apomorphine with ondansetron is contraindicated based upon reports of profound hypotension and loss of consciousness.

Zuplenz is contraindicated for patients known to have hypersensitivity to the drug.

The most common adverse drug reactions (greater than or equal to 5%) reported in clinical trials of patients receiving ondansetron for prevention of nausea and vomiting associated with cancer chemotherapy or concurrent radiotherapy were headache, malaise/fatigue, constipation, diarrhea, and dizziness. In addition, the most common adverse event reported for postoperative nausea and vomiting and occurring at a rate significantly different from placebo was headache.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), excels at finding, enhancing, and bringing to market drugs that make a meaningful difference to patients. For more information about Strativa, visit www.strativapharma.com.

About Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is a U.S.-based specialty pharmaceutical company.  Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press releases and other company information, visit www.parpharm.com.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in lingual, sub-lingual and buccal dissolving films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of currently marketed drugs. The company is a leader in film drug delivery and has a strong intellectual property position, a portfolio of commercialized prescription and OTC drug products, and a pipeline of prescription formulations utilizing its PharmFilm® technology.

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 most recent Annual Report on Form 10-K, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and 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 Strativa Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... , Feb. 8, 2016  Sangamo BioSciences, Inc. ... genome editing, announced that the U.S. Food and ... New Drug (IND) application for SB-318, a single ... for Mucopolysaccharidosis Type I (MPS I). The SB-318 ... to initiate a Phase 1/2 clinical study (SB-318-1502) ...
(Date:2/8/2016)... , February 8, 2016 ... new report published by Allied Market Research titled, ... Opportunities and Forecasts, 2014-2020", estimates the world synthetic ... Nucleotide synthesis and sequencing technology segment would continue ... and software tools segment, collectively, held around half ...
(Date:2/8/2016)... , 8. Februar 2016  LivaNova, PLC, ... eine Infografik mit dem Titel „Epilepsy Around ... mit der der Krankheit gegenüber ein größeres ... ermutigen soll, Medikamentenresistenz bei Epilepsie auf dem ... Diskussion zu machen. Mithilfe der neuen Infografik ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... 08, 2016 , ... Local insurance agency Dennis Fuller & ... has initiated a fundraiser for a two year old little girl named Bella, ... To support this beautiful child who is facing life’s journey without her loving ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... networking and relationship-marketing firm, announced today that nominations will be accepted February ... (ISE®) West Awards. , Awards include the Information Security Executive® of ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... frequently. While a significant number of women and men with eating disorders report ... itself, that best predicts the development of an eating disorder. , At ...
(Date:2/8/2016)... ... 2016 , ... Discover the Rocky Mountain region’s longest running and impressive garden ... Attendees also get to see the most incredible gardens and home improvement experts that ... the Colorado Convention Center - 700 14th St. Denver CO, is an exciting event ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... share this important news! AHCC and the Home Health and Hospice ICD-10 Transition ... designee for official ICD coding guidance and clarifications, to address concerns over the ...
Breaking Medicine News(10 mins):