Today's Date: March 18, 2024
EarthX to Feature Benji Backer, Author of "The Conservative Environmentalist," at Upcoming Congress of Conferences   •   Mbanq and The Financial Policy Council to Host: “Business Banking Battles – Big Value in the Face of Bank Industry T   •   Using Banuba SDKs Gives Businesses an Advantage in the Case of TikTok Ban   •   UNLOCK SPRING LEARNING: THE TOY ASSOCIATION™'S NEW STEAM ACCREDITED TOY LIST OFFERS 25 ENGAGING TOYS FOR KIDS   •   UL Solutions and SINAI Technologies Join Forces to Help Customers Enhance Decarbonization and ESG Performance and Reporting   •   EverWind Fuels Praises Historic Canada-Germany Agreement to Sell Canadian Green Hydrogen   •   Consumers Energy Expands MI Clean Air, Allowing Customers to Offset Carbon Emissions   •   Hyundai Showcases Refined-Rugged SUV Experience in New Asian American Campaign for the All-New Santa Fe   •   Center for Disease Analysis Foundation Announces First Round of Grantees for the CDAF-Relink Grant   •   New ASEAN Energy and ACTUAL Sign Cooperation Agreement to Develop Net-Zero Plan for the New $5B USD Pengerang Energy Complex   •   NAREB PREPARES MEMBERS FOR MAJOR CHANGES TO HOME SALES AGENT COMMISSIONS AFTER LAWSUIT SETTLEMENT   •   Carlisle Companies to Acquire MTL Holdings, a Leader in Edge Metal and Non-Insulated Architectural Wall Systems   •   SBS TO RECEIVE MULTIMILLION DOLLAR SETTLEMENT FROM VOZ MEDIA   •   Statement by Minister Qualtrough on the Closing of the 2024 Arctic Winter Games in the Mat-Su Valley, Alaska   •   College of Saint Mary Selects YuJa Enterprise Video Platform as Campuswide Media Creation and Distribution Solution   •   Cadence and NVIDIA Unveil Groundbreaking Generative AI and Accelerated Compute-Driven Innovations   •   Mitsubishi Electric Named to CDP Supplier Engagement Leader   •   Smarter AI for All: Lenovo Unveils Hybrid AI Solutions that Deliver the Power of Tailored Generative AI to Every Enterprise and   •   TM Associates Announces Grand Opening of Luxury Affordable Apartment Community in DC, MDXL Flats Apartments   •   Spire Global to Enhance AI-Driven Weather Prediction in Collaboration with NVIDIA
Bookmark and Share

FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age

PR Newswire

SILVER SPRING, Md., May 26, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older. VESIcare (solifenacin succinate) tablets were initially approved in 2004 for the treatment of overactive bladder in adults 18 years and older.

"This is the first FDA-approved treatment for NDO patients as young as two years of age," said Christine P. Nguyen, M.D., acting director, FDA's Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research. "In addition, prior to today's approval, the current standard of care for many of these patients required up to three times a day dosing, and this treatment requires only once a day dosing."

NDO is a dysfunction of the bladder that results from disease or injury in the nervous system. NDO may be related to congenital conditions (often-inherited conditions beginning at or before birth), such as spina bifida (myelomeningocele), or other conditions such as spinal cord injury. With NDO, there is overactivity of the bladder wall muscle, which normally relaxes to allow storage of urine. The bladder wall muscle overactivity results in sporadic bladder muscle contraction, which increases pressure in the bladder and decreases the volume of urine the bladder can hold. If NDO is not treated, increased pressure in the bladder can put the upper urinary tract at risk of harm, including possible permanent damage to the kidneys. In addition, spontaneous bladder muscle contractions can lead to unexpected and frequent leakage of urine with symptoms of urinary urgency (immediate urge to urinate), frequency (urinating more often than normal) and incontinence (loss of bladder control).

The efficacy of VESIcare LS for this use was established in two clinical trials with a total of 95 pediatric NDO patients, ages two to 17 years old. The studies were designed to measure (as a primary efficacy endpoint) the maximum amount of urine the bladder could hold after 24 weeks of treatment. In the first study, 17 patients ages 2 to less than 5 years old were able to hold an average of 39 mL more urine than when the study began. In the second study, 49 patients ages five to 17 years were able to hold an average of 57 mL more urine than when the study began. Reductions in spontaneous bladder contractions, bladder pressure and number of incontinence episodes were also observed in both studies.

The most common side effects of VESIcare LS are constipation, dry mouth and urinary tract infection. Somnolence (sleepiness or drowsiness) has been reported with solifenacin succinate, the active ingredient in VESIcare LS. Patients of age who are able to drive or operate heavy machinery should not do so until they know how VESIcare LS affects them. Health care professionals are advised not to exceed the recommended starting dose of VESIcare LS in patients also taking strong CYP3A4 inhibitors. Severe allergic reactions, such as angioedema (swelling beneath the skin) and anaphylaxis, have been reported in patients treated with solifenacin succinate and may be life threatening. Patients should seek immediate attention if they experience swelling of the tongue or throat or difficulty breathing.

VESIcare LS is not to be used in patients with gastric retention (reduced emptying of the stomach), uncontrolled narrow angle glaucoma (fluid buildup in the eye which raises eye pressure) or hypersensitivity (allergic reaction) to VESIcare LS or any of its components. VESIcare LS is also not recommended for use in patients with severe liver failure, clinically significant bladder outlet obstruction in the absence of clean intermittent catheterization, decreased gastrointestinal motility (slowed intestinal contractions), or at high risk of QT prolongation (an electrical disturbance where the heart muscle takes longer than normal to recharge between beats), including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. 

The approval of VESIcare LS was granted to Astellas Pharma US, Inc.

Media Contact: Amanda Turney; 301-796-2969

Consumer Inquiries: Email; 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-approves-first-treatment-for-a-form-of-bladder-dysfunction-in-pediatric-patients-as-young-as-2-years-of-age-301065609.html

SOURCE U.S. Food and Drug Administration



Back to top
| Back to home page
Video

White House Live Stream
LIVE VIDEO EVERY SATURDAY
alsharpton Rev. Al Sharpton
9 to 11 am EST
jjackson Rev. Jesse Jackson
10 to noon CST


Video

LIVE BROADCASTS
Sounds Make the News ®
WAOK-Urban
Atlanta - WAOK-Urban
KPFA-Progressive
Berkley / San Francisco - KPFA-Progressive
WVON-Urban
Chicago - WVON-Urban
KJLH - Urban
Los Angeles - KJLH - Urban
WKDM-Mandarin Chinese
New York - WKDM-Mandarin Chinese
WADO-Spanish
New York - WADO-Spanish
WBAI - Progressive
New York - WBAI - Progressive
WOL-Urban
Washington - WOL-Urban

Listen to United Natiosns News