Navigation Links
Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (LDMP) for Vasomotor Symptoms Associated with Menopause
Date:3/4/2013

MIAMI, FL and NEW YORK, NY, March 4, 2013 /PRNewswire/ -- Noven Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee voted 10 to 4 that the overall risk/benefit profile of low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) is not acceptable to support approval. LDMP is an investigational nonhormonal treatment specifically developed for moderate to severe vasomotor symptoms (VMS) associated with menopause.

Additionally, the committee voted:

  • 7 to 7 that, based on pre-specified analyses, there is sufficient evidence to conclude that LDMP is effective in treating moderate to severe VMS associated with menopause; and
  • 10 to 4 that, based on pre-specified analyses, there is not sufficient evidence to conclude that the change from baseline in VMS frequency is clinically meaningful to women.

The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the ongoing review of the New Drug Application (NDA) that was submitted for LDMP in August 2012. The scheduled Prescription Drug User Fee Act (PDUFA) action date for LDMP is June 28, 2013.

"As conveyed during Noven's presentation, we believe our clinical trial data support LDMP as a safe, effective nonhormonal treatment option offering clinical benefit to menopausal women," said Joel S. Lippman , M.D., Noven's Executive Vice President – Product Development and Chief Medical Officer. "While we are disappointed in today's outcome, we appreciate the discussion and will work closely with the FDA as it completes its ongoing evaluation."

Moderate to severe VMS affect approximately 24 million menopausal women in the United States and approximately two-thirds are not currently treating their VMS with either prescription medication or over-the-counter supplements. There are currently no FDA-approved nonhormonal options for the treatment of VMS.

About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners, with a focus on treatment options for women experiencing menopausal vasomotor symptoms. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu's U.S. growth platform in prescription pharmaceuticals. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.

Contacts
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
305-253-1916

Samantha Schwarz
Executive Director
GolinHarris
312-729-4370


'/>"/>
SOURCE Noven Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Accepts Novens NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms
2. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
3. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
4. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
5. Misonix Announces New Distribution Agreement For Panama
6. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
7. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
8. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
9. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
10. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
11. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... OTTAWA, Ontario , June 27, 2016  VMS ... the Company,s Board will take whatever measures required to ... the Company,s stock which is currently listed on the ... S Wexler, Company Chairman and CEO, "We are seeing ... be difficult to understand, not only by the Company, ...
(Date:6/24/2016)... , June 24, 2016  Global Blood ... biopharmaceutical company developing novel therapeutics for the treatment ... today announced the closing of its previously announced ... stock, at the public offering price of $18.75 ... offering were offered by GBT. GBT estimates net ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
Breaking Medicine Technology:
(Date:6/26/2016)... Battle Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... abuse, joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table ... held in honor of the city’s history as home to some of the world’s ...
(Date:6/26/2016)... Carolina (PRWEB) , ... June 26, 2016 , ... ... of a new product that was developed to enhance the health of felines. The ... centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/26/2016)... ... June 26, 2016 , ... ... they have been diagnosed with endometriosis. These women need a treatment plan to ... a comprehensive approach that can help for preservation of fertility and ultimately achieving ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
Breaking Medicine News(10 mins):