EWING, N.J., Dec. 06, 2019 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (“Antares”) (“the Company”) today announced that the Company’s social media campaign for XYOSTED®, has been honored with a 2019 MarCom Platinum Award. The award is the highest level achievable in the international marketing competition.
The social media campaign for XYOSTED® featured a series of Facebook and Instagram ads to prime existing testosterone deficient patients for the launch of a new testosterone replacement therapy. The ads used humor and arresting imagery which focused on the challenges of other testosterone therapies such as messy application of testosterone gels and painful intramuscular injections. XYOSTED® is a once weekly, virtually painless subcutaneous injection of testosterone which can restore men’s testosterone levels into the normal range. The social media campaign competed with other lifestyle content on the social platforms, with results that exceeded initial expectations.
“We are honored to be recognized by the Association of Marketing and Communication Professionals with such a prestigious award for our XYOSTED social media campaign. Extensive market research with testosterone deficient patients helped us understand the compromises they were making with their current treatment options. We wanted to potentially help these patients, by making them aware of a new treatment option,” said Robert F. Apple, President and Chief Executive Officer of the Company. “We believe that many of our prescribers and patients see the benefits of XYOSTED, a once weekly subcutaneous, virtually pain-free treatment option.”
For complete prescribing information, please visit http://www.xyosted.com
IMPORTANT SAFETY INFORMATION
What is the most important safety information I should know about XYOSTED?
Blood Pressure Increases – XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED.
What is XYOSTED?
XYOSTED is a prescription medicine that contains testosterone. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions.
It is not known if XYOSTED is safe and effective to treat men who have low testosterone due to aging.
It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Improper use of XYOSTED may effect bone growth in children.
XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your XYOSTED in a safe place to protect it. Never give your XYOSTED to anyone else. Selling or giving away this medicine may harm others and it is against the law.
XYOSTED is not meant for use by women.
Do not use XYOSTED if you:
- Are a man who has breast cancer.
- Have or might have prostate cancer.
- Are a woman who is pregnant. XYOSTED may harm your unborn baby.
- Are allergic to XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil.
- Have low testosterone without certain medical conditions. For example, do not take XYOSTED if you have low testosterone due to age.
What should I tell my healthcare provider before using XYOSTED?
Before you use XYOSTED, tell your healthcare provider about all of your medical conditions, including, if you have any of the following: high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder, or problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Using XYOSTED with other medicines can affect each other. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Know the medicines you take. Ask your pharmacist for a list of all your medicines if you are not sure. Show your list to your healthcare provider and pharmacist when you get a new medicine.
How should I use XYOSTED?
- See the detailed Instructions for Use for Information about how to use XYOSTED.
- Use XYOSTED exactly as your healthcare provider tells you to take it.
- Your healthcare provider will show you or your caregiver how to inject XYOSTED. You should not inject XYOSTED until you have been trained on the proper way to use it.
What are the possible side effects of XYOSTED?
XYOSTED can cause serious side effects including:
- See “What is the most important information I should know about XYOSTED?” above.
- Increase in blood pressure. XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.
- Increase in red blood cell count, hematocrit or hemoglobin. High red blood cell counts increase the risk of clots, strokes, and heart attacks. You may need to stop XYOSTED if your red blood cell count increases. Your healthcare provider should check your red blood cell count, hematocrit and hemoglobin while you use XYOSTED.
- Cardiovascular Risk. Possible Increase risk of heart attack, death, or stroke.
- If you already have an enlarged prostate, your signs and symptoms may get worse while using XYOSTED. This can include: increased nighttime urination, trouble starting urination, more frequent urination, feeling an urge to urinate, having a urine accident, and being unable to pass urine or weak urine flow.
- Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use XYOSTED.
- Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
- Abuse. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
- In large doses XYOSTED may lower your sperm count.
- Liver problems. 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).
- Change in mood. Talk to your healthcare provide if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of XYOSTED include: red blood cell increase, prostatic specific antigen (PSA) increase (a blood test for prostate cancer), increased blood pressure, and injection site reactions including bruising, bleeding, redness and headache.
Other side effects include more erections than are normal for you or erections that last a long time. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XYOSTED. For more information, ask your healthcare provider or pharmacist.
For more information, go to www.XYOSTED.com or call 1-844-XYOSTED (1-844-996-7833).
To report side effects to the FDA, visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see the full Prescribing Information, including Boxed Warning, and Medication Guide.
© 2019 Antares Pharma, Inc. All rights reserved.
Hypogonadism, also known as testosterone deficiency or Low T, is a condition in which the body does not produce enough testosterone – the hormone that plays a key role in masculine growth and development during puberty, and maintenance of musculoskeletal, metabolic, and mental health in maturity. Symptoms of male hypogonadism can be treated with testosterone replacement therapy. (see Indications and Usage above)
About Antares Pharma
Antares Pharma, Inc. is a combination drug device company focused primarily on the development and commercialization of self-administered parenteral pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals, Inc. (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s proprietary products include XYOSTED® (testosterone enanthate) injection, OTREXUP® (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: impact of the social media campaign on future XYOSTED® prescriptions, market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva’s generic epinephrine auto-injector product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.’s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; achievement of the 2019 revised revenue guidance; the Company’s ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.
Vice President, Corporate Affairs of Antares