|By PR Newswire||
|June 28, 2013 05:27 PM EDT||
MIAMI, FL and NEW YORK, NY, June 28, 2013 /PRNewswire/ -- Noven Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Brisdelle™ low-dose paroxetine capsules, 7.5 mg/day, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, commonly referred to as hot flashes and night sweats. Prior to the approval of Brisdelle™, hormone therapy was the only FDA-approved treatment for VMS. Many women are unable or unwilling to take hormone therapy to treat their VMS associated with menopause, often leaving symptoms untreated.
"Noven is proud to have developed Brisdelle™, the first and only FDA-approved nonhormonal option for the treatment of moderate to severe VMS, and to be the first company to offer both nonhormonal and hormonal treatment options for women with VMS," said Jeffrey F. Eisenberg, Noven's President and Chief Executive Officer. "We will commercialize Brisdelle™ in the U.S. through our Noven Therapeutics Women's Health division and we estimate that Brisdelle™ will be available in U.S. pharmacies in November 2013."
At the unique low dose of 7.5 mg of paroxetine as a mesylate salt, Brisdelle™ was specifically developed for and studied in women who experience hot flashes and night sweats associated with menopause. Brisdelle™ contains a lower dose of paroxetine than is indicated for any other condition.
"The FDA approval of Brisdelle™ addresses the unmet need for a clinically proven nonhormonal treatment option for hot flashes and night sweats," said David Portman,* M.D., Director of the Columbus Center for Women's Health Research and Brisdelle™ clinical trial investigator. "As a clinician, the comprehensive prescribing information and proven data for Brisdelle™ enable me to confidently offer women with moderate to severe VMS a nonhormonal option that is safe and effective."
Brisdelle™ was clinically proven to reduce the frequency and severity of hot flashes and night sweats. Brisdelle™ was studied in one Phase 2 and two Phase 3 randomized, placebo-controlled trials in 1,276 women with VMS associated with menopause. The most common adverse reactions, defined as those experienced by at least 2 percent of patients taking Brisdelle™ compared to placebo were headache (6.3 vs. 4.8 percent), fatigue/malaise/lethargy (4.9 vs. 2.8 percent) and nausea/vomiting (4.3 vs. 2.3 percent). Of these commonly reported adverse reactions, nausea occurred primarily within the first four weeks of treatment and fatigue occurred primarily within the first week of treatment, and decreased in frequency with continued therapy. Brisdelle™ shares paroxetine warnings and precautions.
"The approval of Brisdelle™ is significant because it meaningfully expands the therapeutic options for the 24 million women in the U.S. affected by moderate to severe VMS, two-thirds of whom are not currently treating these often debilitating symptoms," said Joel Lippman, M.D., FACOG, Noven's Executive Vice President – Product Development and Chief Medical Officer. "Noven has long focused on developing and offering therapies to address women's menopausal health concerns, and we are pleased to address the diverse needs of this population."
In clinical development, Brisdelle™ was referred to as low-dose mesylate salt of paroxetine (LDMP) and Mesafem.
To learn more about Brisdelle™, to register for updates, and for the full Prescribing Information, including the Medication Guide, visit www.Brisdelle.com and read the Important Safety Information below.
BRISDELLE™ (Paroxetine) Capsules is a prescription medicine used to reduce moderate to severe hot flashes associated with menopause.
BRISDELLE contains a lower dose of paroxetine, a medicine also used to treat a number of psychiatric disorders. The lower dose of paroxetine in BRISDELLE has not been studied in any psychiatric conditions and BRISDELLE is not approved for any psychiatric uses.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about BRISDELLE?
Call your healthcare provider right away if you have any of the following symptoms, or go to the nearest emergency room:
Suicidal thoughts or actions:
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Serotonin Syndrome: Nervousness, hallucinations, coma, or other changes in mental status; coordination problems or small movements of the muscles that you cannot control; racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle rigidity; dizziness; flushing; tremors; seizures.
Reduced effectiveness of tamoxifen: Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken at the same time as BRISDELLE. If you are taking tamoxifen, tell your healthcare provider before starting BRISDELLE.
Abnormal bleeding: BRISDELLE may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin, or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, naproxen, or aspirin.
Low salt (sodium) levels in the blood: Elderly people may be at greater risk for this. Symptoms may include: headache; weakness or feeling unsteady; confusion, problems concentrating or thinking or memory problems.
Bone Fractures: Women who take BRISDELLE may have a higher risk of bone fractures.
Manic episodes: Greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.
Seizures or convulsions.
Restlessness: Women who take BRISDELLE may feel an inner restlessness, nervousness, or be unable to sit still or stand still especially when they start taking BRISDELLE.
Who should not take BRISDELLE?
Do not take BRISDELLE if you:
- Take a Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid. Unless directed to do so by your physician, do not take an MAOI within 14 days of stopping BRISDELLE and do not start BRISDELLE if you stopped taking an MAOI in the last 14 days. People who take BRISDELLE close in time to an MAOI may have serious or life-threatening side effects.
- Take thioridazine or pimozide. Do not take thioridazine or pimozide together with BRISDELLE because this can cause serious heart problems or sudden death.
- Are pregnant. BRISDELLE is not for pregnant women. Paroxetine can harm your unborn baby.
What should I tell my healthcare provider before starting BRISDELLE?
Before starting BRISDELLE, tell your healthcare provider if you:
- Have liver or kidney problems; bipolar disorder or mania; low sodium levels in your blood; glaucoma (high pressure in the eye); have or had seizures, convulsions, or bleeding problems; have any other medical conditions; are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines such as migraine headache medication (triptans), other antidepressants and antipsychotics, vitamins, and herbal supplements.
If you take BRISDELLE, you should not take any other medicines that contain paroxetine.
What should I avoid while taking BRISDELLE?
You should not drive, operate heavy machinery, or do other dangerous activities until you know how BRISDELLE affects you.
What are the most common side effects of BRISDELLE?
The most common possible side effects of BRISDELLE include: headache; tiredness; nausea and vomiting.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of BRISDELLE.
Please read the Medication Guide within the full Prescribing Information before taking BRISDELLE. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
During perimenopause, the transition period before a woman reaches menopause, estrogen levels gradually decline and periods may become irregular. Natural menopause is typically confirmed when a woman has missed her menstrual periods for 12 consecutive months. The average age of a woman entering natural menopause is 51 years old. Some women may undergo surgical menopause, which can take place at any age. Surgical menopause occurs when both ovaries are surgically removed (called an oophorectomy), often along with the uterus (called a hysterectomy). Because ovaries are the body's main source of estrogen production, a woman enters menopause when they are removed. The severity of symptoms associated with menopause varies from woman to woman. Hot flashes and night sweats are the most common symptoms of menopause. Because the journey is unique for each woman, it is important for women going through menopause to have a thorough discussion about the transition with their doctors and determine if treatment is appropriate.
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.
* David Portman, M.D., is a compensated consultant for Noven Pharmaceuticals, Inc. Statements attributed to Dr. Portman are his own opinions.
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
SOURCE Noven Pharmaceuticals, Inc.
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, discussed how leveraging the Industrial Internet and...
Jan. 23, 2017 02:00 AM EST Reads: 6,622
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Jan. 23, 2017 01:45 AM EST Reads: 2,743
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, explained the best practices of continuous testing at high scale, which is rele...
Jan. 23, 2017 12:45 AM EST Reads: 4,642
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of D...
Jan. 23, 2017 12:15 AM EST Reads: 5,143
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Jan. 23, 2017 12:00 AM EST Reads: 5,879
Due of the rise of Hadoop, many enterprises are now deploying their first small clusters of 10 to 20 servers. At this small scale, the complexity of operating the cluster looks and feels like general data center servers. It is not until the clusters scale, as they inevitably do, when the pain caused by the exponential complexity becomes apparent. We've seen this problem occur time and time again. In his session at Big Data Expo, Greg Bruno, Vice President of Engineering and co-founder of StackIQ...
Jan. 22, 2017 11:45 PM EST Reads: 7,919
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
Jan. 22, 2017 11:00 PM EST Reads: 4,564
IoT is at the core or many Digital Transformation initiatives with the goal of re-inventing a company's business model. We all agree that collecting relevant IoT data will result in massive amounts of data needing to be stored. However, with the rapid development of IoT devices and ongoing business model transformation, we are not able to predict the volume and growth of IoT data. And with the lack of IoT history, traditional methods of IT and infrastructure planning based on the past do not app...
Jan. 22, 2017 11:00 PM EST Reads: 1,022
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Jan. 22, 2017 08:30 PM EST Reads: 4,698
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
Jan. 22, 2017 07:45 PM EST Reads: 3,867
The proper isolation of resources is essential for multi-tenant environments. The traditional approach to isolate resources is, however, rather heavyweight. In his session at 18th Cloud Expo, Igor Drobiazko, co-founder of elastic.io, drew upon his own experience with operating a Docker container-based infrastructure on a large scale and present a lightweight solution for resource isolation using microservices. He also discussed the implementation of microservices in data and application integrat...
Jan. 22, 2017 07:15 PM EST Reads: 3,648
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, will explore the value of Kibana 4 for log analysis and will give a real live, hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He will examine three use cases: IT operations, business intelligence, and security and compliance. This is a hands-on session that will require participants to bring their own laptops, and we will provide the rest.
Jan. 22, 2017 06:30 PM EST Reads: 5,027
All organizations that did not originate this moment have a pre-existing culture as well as legacy technology and processes that can be more or less amenable to DevOps implementation. That organizational culture is influenced by the personalities and management styles of Executive Management, the wider culture in which the organization is situated, and the personalities of key team members at all levels of the organization. This culture and entrenched interests usually throw a wrench in the work...
Jan. 22, 2017 06:00 PM EST Reads: 1,547
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., and Logan Best, Infrastructure & Network Engineer at Webair, focused on real world deployments of DDoS mitigation strategies in every layer of the network. He gave an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He also outlined what we have found in our experience managing and running thousands of Linux and Unix ...
Jan. 22, 2017 04:15 PM EST Reads: 4,532
"LinearHub provides smart video conferencing, which is the Roundee service, and we archive all the video conferences and we also provide the transcript," stated Sunghyuk Kim, CEO of LinearHub, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 22, 2017 03:15 PM EST Reads: 1,691