ENGLEWOOD, CO / ACCESSWIRE / June 12, 2019 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced that Natesto® has been featured on KPRC-TV, an NBC-affiliated television station in Houston, Texas, in a segment titled: 'Nasal spray for low testosterone preserves fertility.'
Low testosterone affects more than 10% of men worldwide.
The condition can cause fatigue, low libido, and even depression.
Now, a nasal treatment is helping men feel better and keep their dreams of starting a family alive.
Dr. Ranjith Ramasamy, Director of Reproductive Urology at the University of Miami Health System, said, 'At least one in three men between the ages of 32 to 50 appear to have low testosterone.' Ramasamy said factors such as stress, obesity, and poor sleep habits may be to blame. Symptoms include 'low energy, fatigue, improper sleep, weight gain, erectile dysfunction or lack of libido,' Ramasamy explained.
Dr. Ramasamy said testosterone therapies like injections and gels have one major side effect. 'All of these treatments will actually block hormones from the pituitary gland,' Ramasamy stated. Now a treatment called Natesto, applied through the nose, is offering younger patients another option.
'Because this is used two to three times a day and it's short-acting, it still preserves your hormones from the pituitary gland and therefore maintains your sperm production,' Ramasamy stated. He said so far, patients enrolled in a University of Miami study have preserved their fertility and feel great! Ramasamy continued, 'They are able to lose weight, get back to the gym. Obviously, their sex life has improved.'
More information about Natesto can be found at Natesto.com.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or 'Low T'). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.
Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: risks relating to gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future revenue growth, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of Aytu BioScience, Inc.'s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
Important Safety Information About Natesto
INDICATION
What is Natesto (testosterone) Nasal Gel?
Natesto is a prescription medicine that contains testosterone and is used to treat adult males who have low or no testosterone due to certain medical conditions. Your doctor will test the testosterone level in your blood before you start and while you are using Natesto.
Natesto should not be used by men with breast cancer or known or suspected prostate cancer. Natesto should not be used by women.
It is not known if Natesto is safe or effective to treat men who have low testosterone due to aging.
Safety and effectiveness of Natesto have not been established in children younger than 18 years old and Natesto should not be used by children. Natesto use by children may affect bone growth.
Natesto is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Natesto in a safe place to protect it. Never give your Natesto to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.
IMPORTANT SAFETY INFORMATION
Who should not use Natesto?
Do not use Natesto if you:
Are a man who has breast cancer
Have or might have prostate cancer
Are pregnant or may become pregnant or are breastfeeding. Natesto may harm your unborn or breastfeeding baby.
Talk to your doctor before using Natesto if you have any of the above conditions.
What should I tell my doctor before using Natesto?
Before using Natesto, tell your doctor about all of your medical conditions, including if you:
Have or have had nose (nasal) or sinus problems or nasal or sinus surgery
Have had a broken nose (fracture) within the past 6 months
Have or have had a fracture of your nose that caused the inside of your nose to be crooked (deviated anterior nasal septum)
Have or have had problems with swelling of the lining of your nose (mucosal inflammatory disorder)
Have breast cancer
Have or might have prostate cancer
Have urinary problems due to an enlarged prostate
Have heart problems
Have liver or kidney problems
Have problems breathing while you sleep (sleep apnea)
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Using Natesto with certain other medicines can affect each other. Especially tell your doctor if you take:
Insulin
Medicines that decrease blood clotting
Corticosteroids
How should I use Natesto?
Use Natesto exactly as your doctor tells you to. Your doctor will tell you how much Natesto to use and when to use it.
Natesto is for use in your nose (intranasally) only.
Natesto can be used with a type of nasal spray called sympathomimetic decongestants such as oxymetazoline. Natesto should not be used with other nasal sprays. It is not known if Natesto is safe and effective when used with other nasal sprays.
What are the possible side effects of Natesto?
Natesto may cause serious side effects, including:
Nose (nasal) problems. Signs and symptoms of nasal problems may include runny nose, congestion, sneezing, nosebleed, nasal discomfort, nasal scabbing, or nasal dryness.
If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using Natesto. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, and being unable to pass urine or weak urine flow.
Possible increased risk of prostate cancer. Your doctor should check you for prostate cancer or any other prostate problems before you start and while you use Natesto.
Changes in red blood cells.
Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your legs can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Possible increased risk of heart attack or stroke.
In large doses, Natesto may lower your sperm count.
Possible increased risk of liver problems. Signs and symptoms of liver problems may include: nausea or vomiting, yellowing of your skin or whites of your eyes, dark urine, or pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease.
Enlarged or painful breasts.
Problems breathing while you sleep (sleep apnea).
Call your doctor right away if you have any of the serious side effects listed above.
The most common side effects of Natesto include:
Increased prostate-specific antigen (a test used to screen for prostate cancer)
Headache
Runny nose
Nosebleeds
Nose pain
Sore throat, cough
Upper respiratory infection
Sinus infection
Nose scabs
Other side effects include more erections than normal for you or erections that last for a long time.
These are not all the possible side effects of Natesto. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Full Prescribing Information and Patient Information.
Contact for Investors: James Carbonara Hayden IR (646)-755-7412 james@haydenir.com
