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:10/12/2017)... 12, 2017 West Pharmaceutical Services, Inc. ... for injectable drug administration, today announced that it will ... on Thursday, October 26, 2017, and will follow with ... expectations at 9:00 a.m. Eastern Time. To participate on ... The conference ID is 94093362. ...
(Date:10/10/2017)... Calif. , Oct. 10, 2017  NDS received FDA 510(k) ... — a medical-grade battery-powered display stand specifically designed for endoscopy environments. ... transform technology into a clinical solution to support the improvement of ... Innovative Design ... Mobile Wireless Solution ...
(Date:10/4/2017)... 4, 2017  According to the Centers for Disease Control and Prevention ... . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the month. ... health insurance regulations. ... to get a flu shot is by the end of October, according ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , ... mock evacuation of the facility as part of a disaster drill on October 3rd. ... EMS and Shelton City Emergency Manager, as well as the Connecticut Long Term ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Ellevate Network, the ... business to advocate for action towards gender equality at their inaugural Summit in New ... the globe, and reached a social audience of over 3 million. To watch the ...
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... LA (PRWEB) , ... October 12, 2017 , ... Planet ... in the U.S., announced today its plans to open a flagship location in Covington, ... occupy the former Rooms To Go store next to Office Depot in the Holiday ...
Breaking Medicine News(10 mins):