MEMPHIS, NY, February 17, 2019 (GLOBE NEWSWIRE) --Viatris, Inc. (NASDAQ: VINR) (Nasdaq: Viatris), a biopharmaceutical company, today announced that it has received FDA approval for a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating a single dose of sildenafil (Viagra®) 50 mg and 100 mg over-the-counter (OTC) treatment for men with erectile dysfunction (ED) in combination with lifestyle changes for an improved quality of life.
This Phase 2b study will be conducted in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision, text content (DSM-IV-TR) and published in the American Journal of Psychiatry. The study will enroll men with ED and a baseline assessment will be performed prior to treatment initiation.
The study will enroll patients who are taking sildenafil (Viagra®) 50 mg and 100 mg. Patients will be randomly assigned to one of two treatment groups: either sildenafil (Viagra®) 50 mg or 100 mg plus a placebo, and either sildenafil (Viagra®) 50 mg or 100 mg plus a placebo. The trial will be completed at baseline, and the patients will be followed for up to 6 months. Additional clinical assessments will be performed during treatment initiation, during the initial weeks, and throughout the study.
A total of 514 patients will be enrolled and randomized to receive sildenafil (Viagra®) 50 mg or 100 mg, or a placebo, at baseline and at subsequent visits. All patients will be assessed at baseline and throughout treatment. The primary endpoint of the study will be the change from baseline in the total International Index of Erectile Function-Erectile Function (IIEF-EF) total score at 12 weeks. Secondary endpoints will be the change from baseline in the IIEF-EF total score at 24 weeks and at 12 and 24 months. Treatment duration will be determined by the physician’s discretion.
“This Phase 2b study will be a critical step toward improving the quality of life for men with ED,” said John J. Allen, MD, PhD, professor of medicine and head of the Division of Urology at the Mayo Clinic and Director of the Sexual Medicine and Health Program. “This Phase 2b study will provide a significant improvement in quality of life for ED patients as a result of the combination of lifestyle changes, psychological stress, and medication to improve erectile function.”
“We are pleased that the Phase 2b trial is an important part of our efforts to improve the quality of life for men with ED,” said John J. “This is an important step toward improving the quality of life for men with ED, and we are excited to work with Viatris to develop a trial that is more meaningful for the American Men’s Health Initiative (AHP) population.”
For more information on Viatris’s clinical experience with the treatment of ED, please visit:
Website:Forward-Looking Statements
This press release contains forward-looking statements that include statements that involve a number of risks and uncertainties including that identify Viatris does not immediately comply with federal law, and that Viatris does not guarantee that Viatris will be able to fulfill such requirements. As a result of such risks, there is a reasonable assurance that Viatris will not be able to successfully meet Viatris’s obligations under federal law or that Viatris will comply with such requirements. Such forward-looking statements involve risks and uncertainties that are beyond the control of Viatris’s management and that Viatris is taking all reasonable steps to manage such risks and uncertainties.
As the market for erectile dysfunction medications continues to evolve, a number of potential drug interactions and/or drug defects will become evident. These risks and uncertainties are inherent to the development, manufacturing and marketing of a new medication, and even in the manufacture and marketing of a new medication. The success of such potential drug interactions and/or drug defects is a subject of significant research and development and is expected to be substantial for Viatris, including for its commercialization and regulatory acceptance, regulatory acceptance and the market for erectile dysfunction medication.
Viagra has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Viagra use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Viagra. Viagra can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any nitrate medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
These include diabetes, high blood pressure, or a history of certain heart conditions.otsimunt UAE pharmaceuticals manufacturerIn addition, let your doctor know if you are currentlyINOOS or if you are currentlyusing prescription medications as some medications may interact with Viagra. Some concomitant medications you have been prescribed include riociguat, itraconazole, and ketoconazole.atonin-binding substances, such as agranulatoine, lecithin, and glycerol, are sometimes prescribed to slow heart rhythm.
asthma medical professionalIn addition, let your doctor know if you are currently having liver or kidney disease. Viagra may interact with these medications including metabolized———————————————
mercury (mercury)In addition, let your doctor know if you currently have asthma or have any allergies. Viagra can interact with these medications including metabolized———————————————
hydrochlorothiazideIn addition, let your doctor know if you are currently taking any medications that can affect the heart rhythm.
Viagra may interact with these medications include metabolized———————————————
Viagra may interact with these medications include metabolized——————————————
IMPORTANT NOTICE: Please be aware, prior to sale, you are advised to have a short phone call consultation with our Pharmacist. Automatic purchase consents the Pharmacist to give you a quick call.
Viagra Connect is available without a Prescription but requires a brief consultation with the Pharmacist. It is available in a 4 pack or an 8 pack. Viagra Connect contains Sildenafil 50mg which works by relaxing the penis blood vessels, allowing blood to flow when you get aroused causing erections and potency. Viagra Connect will only help men become erect if you are aroused. Only for adult use, men 18 years plus.
How to be taken:
VIAGRA CONNECT is not to be taken if:
Please read instructions carefully provided.
Viagra Connect is a fast acting drug for erectile dysfunction which can last up to 4 hours and takes effect within 30 minutes after administration.
Sildenafil Citrate 50 mg Tablets: This tablet is specifically formulated to treat the symptoms of erectile disfunction and is highly effective in treating it, the most common sexual disorder affecting men over the age of 40 years. Provides a solution to erectile dysfunction in men who suffer from impotence due to conditions such as heart disease or diabetes, or who have problems with their physical or mental health.
Viagra Connect ensures fast and effective results that last as long as 36 hours and come without side effects. It works by relaxing the blood vessels in the penis, allowing blood to flow into the phallus when you get sexually excited and causing the desired stiffness.
amaraakindra Sildenafil 50 mg Tablets: A potent and highly effective treatment for erectile dysfunctionBryceakindra Sildenafil 50 mg Tablets are a powerful and easy to take option for men suffering from erectile dysfunction. They can help get and maintain an erection for longer, allowing for easier sexual activity.
Viagra Connect works by relaxing the blood vessels in your penis, allowing blood to flow into your penis when you are aroused. This allows your penis to relax, allowing for a firmer, longer-lasting erection.Viagra Connect can take between 30 and 60 minutes to work. Please read instructions carefully provided with the product before taking this medicine.
It is advised that you don’t have a heart problem before starting Viagra Connect. It can lead to a very serious health problem.
Viagra has been shown to cause some mild side effects. Talk to your health care provider if these do not go away within a few days. If you begin to experience more serious reactions, seek medical attention immediately.
Common side effects reported from Viagra use include:
More severe side effects include:
If you experience any of these side effects, seek medical attention immediately. These are symptoms of a severe adverse reaction to this medication that require immediate treatment.
As with all prescription medications, inform your doctor of any medical conditions you currently manage. Tell them about any and all medications, prescription drugs, and supplements you are taking before starting treatment with Viagra. Viagra can interact with bodily substances, causing potentially serious adverse reactions.
Specifically, you should inform your health care provider of any nitrate medication you are taking. Remember to mention any herbal products you use, especially St. John’s wort.
In addition, let your doctor know if you have recently had heart surgery or experience chest pain during sex. If you experience any changes in your heartbeat or chest pain during sex, contact your health care provider immediately.
Show Moreuspress: We will listen to youName what is your best defense against erectile dysfunction with Viagra; it lasts for up to 4 hours.
Show Moreuspress: Name what your best defense against erectile dysfunctionIt lasts for up to 4 hours.
AddgNb: Check if you are currently using any other medications, including nonprescription products?This check is necessary tolaim in regards to Viagra use.
Show Moreuspress: Check if you are currently using any other products, including nonprescription products?
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