Pharmacy Drugs
Recent Posts
- Malignant Brain Tumors: Chemotherapy Alone Is Just As Effective As Radiation / New Positive Prognostic Factor Found
- Positive Interim Data From Minnow Medical Peripheral Artery Disease Trial Presented At TCT 2009 Conference
- Intercept Pharmaceuticals’ FXR Agonist INT-747 Meets Primary Endpoint In A Phase II Clinical Trial In Type 2 Diabetic Patients
- Largest Clinical Trial To Test Benefits Of Aspirin In Australia
- University Of Florida To Receive $29.5 Million In Recovery Act Funds To Begin Study Of Whether Exercise Prevents Disability In Older Adults
Random Posts
- First Skin Cancer Patients Treated With Electronic Brachytherapy (eBx) At University Of Wisconsin Riverview Cancer Center
- Research Reveals Lipid's Unexpected Role In Triggering Death Of Brain Cells
- New Stem Cell Research Unlocks Unknown Therapies
- ExonHit Announces Last Patient Out For EHT 0202 Phase IIa Study In Alzheimer's
- News From The Journal Of The National Cancer Institute, May 12, 2009
- Medtronic Clinical Trial Evaluating The Industry's First Cryoballoon Technology Designed For Paroxysmal Atrial Fibrillation Completes Follow Up
- Celator(R) Pharmaceuticals Completes Enrollment Early In Phase 2 Study Of CPX-351 In Newly Diagnosed AML
- FDA Accepts Arno Therapeutics' IND For AR-12 A PDK1 Inhibitor That Blocks The PI3K/Akt Pathway
- APESMA Boost For Pharmacists' Support Service, Australia
- Prices Of Medicines Hit All-time Low, UK
Noven Reports Positive Phase 2 Results For Mesafem™ Non-Hormonal Therapy For Vasomotor Symptoms
Posted by: admin in Pharmacy Drugs on July 23rd, 2009
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced positive top-line results from its Phase 2 clinical study evaluating Mesafem™ (low-dose paroxetine mesylate) for the treatment of vasomotor symptoms (hot flashes) associated with menopause (”VMS”).
This was a multi-center, double-blind, randomized, placebo-controlled Phase 2 efficacy and safety study of Mesafem in the treatment of VMS. The eight-week study, sponsored by Noven, enrolled 102 patients (with 98 patients completing) at ten clinical locations in the U.S. Patients in the active arm of the study received a dose of Mesafem below 10mg once daily. The primary objective of the study was to assess the safety and efficacy of Mesafem for the treatment of VMS. The primary outcome measures were mean changes in frequency and severity of moderate-to-severe hot flashes from baseline to the fourth and eighth weeks of the study.
“Although designed and powered to detect an efficacy signal, we were very pleased to achieve statistical significance in several primary outcome measures, and to identify clear efficacy signals in the others,” said Joel S. Lippman, M.D., Noven’s Vice President - Clinical Development & Chief Medical Officer. “Safety and tolerability of Mesafem were similar to placebo, with no drug-related serious adverse events. In short, Mesafem appears to be efficacious and well-tolerated at the tested dose, and information from this study should permit us to develop and initiate a well-designed and cost-effective Phase 3 clinical program by year-end.”
Peter Brandt, Noven’s President & CEO, said: “Today’s Phase 2 results exceeded all our internal expectations from the standpoints of both efficacy and tolerability. With the data from this study, we plan to expedite Mesafem into Phase 3 development, and to advance our commercialization and partnering strategies, with the goal of making this new non-hormonal treatment option broadly available to women who suffer from VMS, but who are not candidates for, or who have concerns about, hormone therapy.”
Concurrent with this announcement, Noven issued a press release announcing that it had entered into a definitive merger agreement with Hisamitsu Pharmaceutical Co., Inc. That press release is available at http://www.noven.com.
Source
Noven Pharmaceuticals, Inc.
No Comments »
No comments yet.
RSS feed for comments on this post. TrackBack URL
Leave a comment
You must be logged in to post a comment.