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Fda Approves Gemtesa For Overactive Bladder

Bladder Cancer and Immunotherapy with Dr. Arjun Balar

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The FDA recently approved a new drug application for Gemtesa, a novel treatment for overactive bladder in adults, its manufacturer announced in a press release.

Gemtesa helps relax the detrusor bladder muscle, enabling the bladder to hold more urine, thereby reducing symptoms of overactive bladder, according to the manufacturer.

Gemtesa is the first beta 3-agonist available as a once-daily pill which does not require dose titration,David Staskin, MD, a clinical trial investigator and a leading urologist at St. Elizabeths Medical Center in Boston, said in a press release.

The FDAs approval of vibegron was based on data from the 12-week, double blind, placebo-controlled, phase 3 EMPOWUR study, which included more than 4,000 patients with overactive bladder. The results showed that vibegron was associated with statistically significant reductions in daily urge urinary incontinence, micturitions and urgency episodes, according to the press release.

The most common adverse events tied to vibegron use were diarrhea, headache, nasopharyngitis, nausea and upper respiratory tract infection, Urovant Sciences said in the release.

Medications For Unspecified Oab

If your doctor cant find a cause for your OAB, dont worry. Drugs can still help ease your symptoms. Some of these drugs work by relaxing your bladder. They stop involuntary contractions that bring on the urge to urinate. Other drugs help strengthen the tissues around your bladder that may have become weak. The stronger tissue can help improve your bladder control.

Gemtesa Receives Us Fda Approval For The Treatment Of Patients With Overactive Bladder

GEMTESA is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant SciencesU.S. commercial launch planned in late-Q1 2021

The clinical data for once-daily 75 mg GEMTESA demonstrated clear efficacy on the key symptoms of OAB by reducing urinary frequency, urge urinary incontinence, and urgency. In addition, data specifically showing reduction in urgency episodes are included in the Prescribing Information of GEMTESA, which is unique among currently-available OAB treatments. Urgency episode reduction data are particularly relevant for OAB patients and their health care providers, as they show GEMTESAs direct impact on a hallmark symptom of the condition, said Cornelia Haag-Molkenteller, M.D., Ph.D., chief medical officer of Urovant Sciences. By successfully treating clinical symptoms, GEMTESA may allow patients to overcome the devastating impact that OAB can have on their daily lives.

About Overactive BladderWhat is GEMTESA?

  • urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • urgency: the need to urinate right away
  • frequency: urinating often
  • Staskin, D., 2020. International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR | Journal of Urology.https://www.auajournals.org/doi/10.1097/JU.0000000000000807
  • Recommended Reading: How To Prevent Bladder Infection After Intercourse

    How Does Innovo Work

    Contrary to my belief, Innovo products arent magic. They use a combination of convenience and science, a mix thats made them so successful and loved by the millions.

    The prescribed plan? I learned that the brand implements a 12-week journey to keep you on track towards your goal starting with 30 minute sessions, five days a week. You should begin to see resultsmeaning less leaks and a stronger pelvic flooraround the four-week mark.

    Start by purchasing the Starter Kit, which contains everything you need to begin the program. Innovo offers extra pairs of Supplemental Shorts and Spray Replacement Bottles to up the convenience.

    From what Ive read, the program sounds super easy to follow. You simply have to wear the shorts and press a button. Then, sit back and relax without experiencing any muscle fatigue. How do they work? By sending electrical impulses to stimulate key muscles.

    Now that you know how the process works, coming up in this Innovo review, Ill give you a look at the brands subscription options.

    Looking to get started with pelvic floor exercise devices? The brand is ready for you with the Innovo Starter Kit.

    The kit consists of one pair of shorts, a spray bottle to use for the sensors, a remote to control the impulses, and an instruction manual so you always know what to do. I love that its a non-invasive treatment that anyone can do in the comfort of their own home.

    Prescription Drugs For Overactive Bladder

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    There are several prescription drugs for overactive bladder .

    The FDA approved medications, or drugs, currently available on the U.S. market for the treatment of urinary incontinence are for a specific condition called overactive bladder . Some are also used for OAB with urge urinary incontinence . You may have seen advertisements on television or in magazines for these medications. Most of the prescription drugs for OAB partially calm the bladder muscles that cause abnormal contractions, thereby reducing the frequency and severity of the overwhelming urge to urinate. Some of these drugs may also increase the bladders capacity to hold urine and delay the initial urge to void. This class of drugs is referred to as antimuscarinics.

    The currently FDA approved antimuscarinic drugs for OAB are: Oxybutynin, Tolterodine, Solifenacin, Hyoscyamine, and Darifenacin. These drugs are sold under the names of: Ditropan, Detrol, Vesicare, Enablex, Levbid, Cytospaz and Oxytrol. Most of these are oral medications and need a doctors prescription. Only one drug will be available over-the-counter as of September 2013, and it is in a skin patch form for women only.

    Note: Drugs that are currently approved may be suddenly taken off the market, and new drugs are being introduced. Your healthcare provider and pharmacist can help you know which current drugs on the market may be the best for your circumstances.

    Who May Need a Prescription?

    Possible Side Effects

    Key Points to Remember

    Read Also: Causes Of Weak Bladder Muscles

    Anticholinergic Drugs For Oab

    The largest class of drugs used to treat OAB is anticholinergic drugs. They work by blocking a chemical in your body called acetylcholine. This chemical sends a message to your bladder to contract. By blocking this chemical, these drugs reduce the contractions that cause you to release urine. In studies that compared the drugs, all anticholinergics worked in treating OAB.

    Anticholinergics are sold under different brand names. Some are also available as generic drugs. These medications include:

    All of these drugs except for Oxytrol come as either tablets or capsules that you take by mouth. Oxytrol is available as a skin patch.

    The most common side effects of anticholinergic drugs include:

    Seniors have the greatest risk of side effects from these drugs. These medications may also cause drowsiness and an increased risk of falls in seniors. Oxybutynin may cause more side effects than the other drugs in this class. However, taking oxybutynin in its extended-release form may reduce some of the side effects. Anticholinergics may also worsen dementia symptoms and should be used with caution in people with this disease.

    Can Gemtesa Be Crushed Split Or Chewed

    Yes, Gemtesa tablets can be crushed and mixed into 1 tablespoon of applesauce. Once you crush the tablet and mix it into the applesauce, be sure to take it immediately. Also, you should take your Gemtesa and applesauce dose with a full glass of water.

    The drugs manufacturer hasnt stated whether Gemtesa can be split or chewed.

    If you have any questions about crushing, splitting, or chewing Gemtesa, talk with your doctor or pharmacist.

    Gemtesa is approved to treat overactive bladder in adults.

    With OAB, you may have sudden or uncontrollable urges to urinate. You may also have urinary:

    Gemtesa works by relaxing the muscle in your bladder that controls your bladder capacity. This means that more urine can be stored in your bladder before you have to urinate. In this way, Gemtesa helps to decrease urinary incontinence, urgency, and frequency.

    Also Check: Bladder Leakage Only At Night

    Fda Approves Mirabegron Solifenacin Combo For Oab

    Troy Brown, RN

    May 09, 2018

    The US Food and Drug Administration has approved mirabegron in combination with solifenacin succinate for the treatment of overactive bladder accompanied by symptoms of urge urinary incontinence, urgency, and urinary frequency.

    The FDA approvedmirabegron, a beta-3 adrenergic agonist, for OAB in June 2012. The FDA approvedsolifenacin succinate, a muscarinic antagonist, as a monotherapy for the disorder in November 2004.

    “OAB patients may have symptoms that are not fully managed with their current treatment,” Carol Schermer, MD, MPH, senior medical director, urology, Astellas, said in a news release. “With the FDA approval of Myrbetriq in combination with solifenacin succinate, Astellas is able to offer an additional treatment option to individuals living with symptoms of OAB.”

    The approval follows consideration of data from three large, global phase 3 trials that compared combination therapy with monotherapy: SYNERGY I, SYNERGY II, and BESIDE.

    SYNERGY I and SYNERGY II compared mirabegron/solifenacin combination therapy to solifenacin monotherapies. Patients were followed for 12 in SYNERGY I and for 52 weeks in SYNERGY II.

    In BESIDE , mirabegron 50 mg in combination with solifenacin 5 mg was superior to solifenacin 5 mg alone for relieving symptoms of incontinence and frequent urination.

    Most treatment-emergent adverse events were mild or moderately severe.

    For more news, join us on and

    Fda Approves Botox For Overactive Bladder

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    The popular Botox wrinkle treatment made by Allergan Inc has been approved to treat adults with overactive bladder who cannot tolerate or failed to be helped by other drugs for the condition, the U.S. Food and Drug Administration said on Friday.

    Botox injected into the bladder muscle causes the bladder to relax, increasing its storage capacity and reducing episodes of urinary incontinence, or leakage.

    “Clinical studies have demonstrated Botox’s ability to significantly reduce the frequency of urinary incontinence,” Hylton Joffe, director of the FDA’s Division of Reproductive and Urologic Products, said in a statement. “Today’s approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States.”

    Botox had previously been approved for other non-cosmetic uses, such as migraine headaches, severe underarm sweating and loss of bladder control due to nerve damage.

    Allergan, which has yet to report full year financial results, said it expects 2012 Botox sales of $1.76 billion to $1.8 billion. Analysts have said that approval for overactive bladder could add more than $200 million a year to Botox sales.

    The treatment can be repeated when the effect wears off, but with a gap of at least 12 weeks between treatments, the FDA said.

    Recommended Reading: How To Tell If You Have A Bladder Infection Female

    Fda Approves Generic Treatments For Overactive Bladder

    Solifenacin succinate tablet is a muscarinic antagonist indicated to treat this condition, with symptoms of urgency, urge urinary incontinence, and urinary frequency.

    Alembic Pharmaceuticals and Glenmark Pharmaceuticals have both received FDA approval for generic solifenacin succinate tablets, 5 mg and 10 mg, a therapeutic equivalent to Astellas Vesicare tablets, 5 mg and 10 mg.1,2

    Alembic and Glenmark are among a small handful of companies, including Teva, working to produce this medication.1-3

    Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urgency, urge urinary incontinence, and urinary frequency.1

    In the United States, solifenacin succinate tablets, 5 mg and 10 mg, have an estimated market size of $927 million to $967 million for the 12 months ended December 2018, according to IQVIA.1-3

    According to Alembic, the company has a total of 94 abbreviated new drug application approvals, including 82 final approvals and 12 tentative approvals, from the FDA.1

    Glenmarks portfolio consists of 154 products authorized for distribution in the United States and 58 ANDAs pending approval with the FDA.2

    In April, Teva launched its version of solifenacin succinate tablets, 5 mg and 10 mg.3


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    Checkpoint Inhibitors And Bladder Cancer

    Long-term survival for people diagnosed with advanced bladder cancer is poor, with approximately 5% of patients with metastatic bladder cancer surviving for 5 years or more.

    Checkpoint inhibitors have shown activity in patients with metastatic bladder cancer in both the second-line setting and the first-line setting , explained Andrea B. Apolo, M.D., who heads the Bladder Cancer Section in NCIs Center for Cancer Researchs Genitourinary Malignancies Branch.

    But we still needand are awaitingthe results of ongoing randomized trials comparing checkpoint inhibitors and chemotherapy in the first-line setting for patients with metastatic bladder cancer, she continued. The results will allow us to adequately compare patient outcome in terms of survival and quality of life with these therapies.

    With the exception of pembrolizumab, the drugs covered by these approvals target a protein known as PD-L1 that is expressed at high levels on some cancer cells. Pembrolizumab targets PD-1, the receptor protein for PD-L1, on immune cells. Normally, binding of PD-L1 to PD-1 tamps down immune activity. By preventing the interaction between PD-L1 and PD-1, all four drugs can allow the immune system to be more active against tumor cells.

    The other checkpoint inhibitor approved by the FDA for the treatment of patients with bladder cancer, nivolumab , targets PD-1.

    Also Check: Bcg Drug For Bladder Cancer

    Urovant Sciences Announces Us Fda Approval Of Gemtesa 75 Mg Tablets For The Treatment Of Patients With Overactive Bladder

    GEMTESA is the first new oral branded OAB medication approved by the U.S. FDA since 2012 and the first product approval for Urovant Sciences

    U.S. commercial launch planned in late-Q1 2021

    IRVINE, Calif. & BASEL, Switzerland—- Urovant Sciences, Inc announced today that the U.S. Food and Drug Administration has approved the New Drug Application for once-daily 75 mg GEMTESA® , a beta-3 adrenergic receptor agonist, for the treatment of overactive bladder with symptoms of urge urinary incontinence , urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.

    The FDAs approval of GEMTESA is an important milestone for the tens of millions of patients living with overactive bladder and for Urovant, as it is our first drug approval. We look forward to launching GEMTESA in the coming months and believe that it will provide a compelling alternative for the many patients suffering from the burden of an overactive bladder. We also remain committed to bringing more new therapies to market that address unmet medical needs of patients suffering from urologic diseases, said Jim Robinson, president and chief executive officer of Urovant Sciences.

    Urovant is planning to launch GEMTESA in the United States late in the first quarter of 2021. To learn more about GEMTESA, please visit GEMTESA.com.

    About Overactive Bladder

    What is GEMTESA?

    Fda Approves Ecoin Tibial Neurostimulator For Overactive Bladder

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    The FDA has approved the eCoin leadless tibial neurostimulator for the treatment of urinary urge incontinence , a condition experienced by more than 60% of patients with overactive bladder.1

    The approval was based on results from a pivotal, open-label, single-arm trial that were previously published in the Journal of Urology.2 The eCoin device met the primary end point of the study by achieving a 50% improvement in urgency urinary incontinence in 68% of patients after 48 weeks of treatment.

    “Beyond delivering impressive results achieved without the need for prior screening, the eCoin procedure is easily understood by patients, reproducible amongst physicians, and accomplished in a safe and effective manner,” Rebecca McCrery, MD, an investigator in the eCoin pivotal trial and urologist at Nebraska Medicine, stated in a news release.

    “Under 5% of OAB patients select burdensome third line interventions due to invasiveness or potential side effects of available therapies and limitations in access, resulting in a staggering unmet clinical need. The effortless relief provided by the automatic nature of eCoin neuromodulation therapy will potentially better treat the vast populationoften desperate for reliefwho are not well managed by the current options available to them,” added McCrery.


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    Use Of Myrbetriq And Important Safety Information

    Do not take MYRBETRIQ® if you are allergic to mirabegron or any ingredients in MYRBETRIQ. MYRBETRIQ may cause your blood pressure to increase or make your blood pressure worse if you have a history of high blood pressure. You and your doctor should check your blood pressure while you are taking MYRBETRIQ.

    Financial And Insurance Assistance

    If you need financial support to pay for Gemtesa, or if you need help understanding your insurance coverage, help is available.

    Urovant Sciences GmbH, the manufacturer of Gemtesa, offers the Gemtesa Simple Savings Program. This program offers options to help lower the cost of Gemtesa. For more information and to find out if youre eligible for support, call 833-UROVANT or visit the programs website.

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    ‘clear Need For New Drugs’

    Urologist Elizabeth Kavaler, MD, of Lenox Hill Hospital in New York City, says there is a clear need for new types of drugs that work in new ways to treat overactive bladder.

    She says the previously approved prescription medications available in the U.S. all work in the same way.

    “These drugs are very effective — around 90% of patients who take them respond,” she tells WebMD. “The problem is that many patients find they can’t or don’t want to take these drugs.”

    She says that’s because of common side effects that include:

    Kavaler recommends that people with overactive bladder first try making changes in behavior. These changes can include limiting or eliminating bladder irritants such as:

    People with OAB can also reduce drinking all fluids and practice Kegel exercises to strengthen pelvic muscles.

    If these lifestyle changes do not improve symptoms, medication may be needed, she says.

    Kavaler says Myrbetriq may prove to be easier to tolerate for patients who either can’t take the previously available drugs or who find the side effects intolerable.

    “Clearly, we have a huge need in this area, as evidenced by the fact that so many companies are marketing what is essentially the same drug,” she says. “It will be nice to have something different to offer.”

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