OTREXUP provides a new option that may
benefit patients when the response to oral methotrexate is
inadequate
Antares Pharma, Inc. (NASDAQ: ATRS) today announced the
availability of OTREXUP™, the first U.S. Food and Drug
Administration (FDA) approved subcutaneous (SC) methotrexate (MTX)
product for once weekly self-administration with an easy-to-use,
single dose, disposable auto injector. OTREXUP was approved by the
FDA in October 2013. OTREXUP is available at distribution centers
throughout the USA.
Approximately 1.3 million Americans are diagnosed with RA and
about 7.5 million with psoriasis. Initial treatment of these
conditions with oral MTX usually provides a good response for many
patients. However, some patients find it difficult to tolerate the
oral formulation and/or receive limited benefit, especially when
higher doses are required for a satisfactory response. Absorption
following oral dosing showed a plateau effect at doses of 15 mg and
greater.
“OTREXUP provides an attractive new option that may benefit
patients who have had an inadequate response to or are intolerant
of oral MTX,” said Paul K. Wotton, PhD, President and Chief
Executive Officer, Antares. “OTREXUP is an easy-to-use auto
injector that delivers greater blood levels of medication than oral
MTX. OTREXUP could extend the use and benefits of MTX and
potentially delay or avoid the use of other more expensive
treatment options in some patients.”
OTREXUP is indicated for adults with severe active rheumatoid
arthritis (RA) who have had an insufficient therapeutic response to
or are intolerant of an adequate trial of first line therapy
including full dose non-steroidal anti-inflammatory agents
(NSAIDs), and children with active polyarticular juvenile
idiopathic arthritis (pJIA). OTREXUP also is indicated for use in
adults who need symptomatic control of severe recalcitrant,
disabling psoriasis that is not adequately responsive to other
forms of therapy.
“CreakyJoints welcomes new treatment options for patients with
RA,” said Seth Ginsberg, president and co-founder of CreakyJoints,
one of the nation’s largest rheumatic disease patient advocacy
groups. “Because so many RA patients have limited manual dexterity,
conventional syringes for injection of methotrexate are often
difficult to use. An easy delivery system that combines
subcutaneous methotrexate with a pre-filled auto-injector is an
important addition to treatment options available because it
expands RA patients’ access to care.”
The injectable use of MTX after an inadequate response to oral
MTX is quite common in Europe and elsewhere in the world. In the
United States, however, use of injectable MTX is often overlooked
primarily due to the challenges of self-injection. The fear of
needles, poor manual dexterity, especially in people living with
RA, and a lack of confidence in accurately and safely
self-injecting with a vial, needle and syringe may be some of the
challenges people have to face.
“OTREXUP is a useful new treatment option that physicians can
consider for their patients who could continue to benefit from MTX
when their tablets provide an inadequate response,” said Alvin F.
Wells, MD, PhD, Director, Rheumatology & Immunotherapy Center,
located in Franklin, Wisconsin. “An easy-to-use and almost
pain-free injection can provide the higher blood levels of
medication that may be necessary for these patients.”
“Antares is committed to the consistent availability of OTREXUP
and the support that patients and healthcare providers need,” said
LeRoux Jooste, SVP and General Manager, Antares Pharmaceuticals.
“We have shipped OTREXUP to distribution centers throughout the US
and have ample inventory of OTREXUP available to supply the market.
As a research and development company, we plan ahead to ensure that
OTREXUP remains an available treatment option for the patients who
need it.”
For full prescribing information please visit
WWW.OTREXUP.COM.
Important Safety
Information
Otrexup is a single-dose auto-injector containing a prescription
medicine, methotrexate. Methotrexate is used to:
- Treat certain adults with severe active
rheumatoid arthritis, and children with active polyarticular
juvenile idiopathic arthritis (pJIA), after treatment with other
medicines, including nonsteroidal anti-inflammatory drugs (NSAIDs)
have been used and did not work well
- Control the symptoms of severe,
resistant, disabling psoriasis in adults when other types of
treatment have been used and did not work well
Otrexup should not be used for the treatment of cancer. Otrexup
should not be used for the treatment of children with
psoriasis.
Methotrexate includes the following boxed warning:
Otrexup can cause serious side effects that can lead to
death, including:
- Organ system toxicity. People
who use methotrexate for the treatment of cancer, psoriasis, or
rheumatoid arthritis have an increased risk of death from organ
toxicity. Types of organ toxicity can include gastrointestinal,
bone marrow, liver, immune system, nerve, lung, kidneys, and
skin.
Your doctor will do blood tests and other types of tests before
you take and while you are taking Otrexup to check for signs and
symptoms of organ toxicity. Call your doctor right away if you have
any of the following symptoms of organ toxicity: vomiting,
diarrhea, mouth sores, fever, confusion, weakness, temporary
blindness, seizures, headache, back pain, neck stiffness,
paralysis, irritability, sleepiness, problems with coordination,
dry cough, trouble breathing, and severe skin rash.
- Women who are pregnant are at
increased risk for death of the baby and for birth defects in the
baby. Women who are pregnant or who plan to become pregnant
must not take Otrexup. A pregnancy test should be performed
before starting Otrexup.
Contraception should be used by both females and males while
taking Otrexup. Pregnancy should be avoided if either partner is
receiving Otrexup:
- For a minimum of 3 months after
treatment with Otrexup for males.
- During and for at least 1 menstrual
cycle after treatment with Otrexup for females.
What are the possible side effects of Otrexup?
Otrexup may cause serious side effects, including:
- Fertility problems.
Methotrexate, the active ingredient in Otrexup, may affect your
ability to have a baby. Males may have a decreased sperm count, and
females may have changes to their menstrual cycle. This can happen
while taking Otrexup and for a short period of time after you
stop.
- Certain cancers. Some people who
have taken methotrexate have had a certain type of cancer called
Non-Hodgkin’s lymphoma and other tumors. Your doctor may tell you
to stop taking Otrexup if this happens.
- Tissue and bone problems. Taking
methotrexate while having radiation therapy may increase the risk
of your tissue or bone not receiving enough blood. This may lead to
death of the tissue or bone.
Common side effects of Otrexup include: nausea, stomach pain,
indigestion (dyspepsia), mouth sores, and rash.
Who should not take Otrexup?
Do not take Otrexup if you:
- Are pregnant or planning to become
pregnant
- Are breastfeeding; Otrexup can pass
into your breast milk and may harm your baby
- Have alcohol problems (alcoholism)
- Have liver problems
- Have problems fighting infection
(immunodeficiency syndrome)
- Have been told you have (or think you
have) a blood disorder such as low levels of white blood cells, red
blood cells (anemia), or platelets
- Have had an allergy to methotrexate or
any of the ingredients in Otrexup
What should I tell my doctor before taking Otrexup?
Before you take Otrexup, tell your doctor if you have any other
medical conditions. Tell your doctor about all of the medicines you
take, including prescription medicines, over-the-counter medicines,
vitamins, and herbal supplements.
Otrexup may affect how other medicines work, and other medicines
may affect how Otrexup works, causing side effects. Ask your doctor
or pharmacist for a list of medicines if you are not sure.
Tell your doctor if you have any side effect that bothers you or
that does not go away. These are not all the possible side effects
of Otrexup. For more information, ask your doctor or
pharmacist.
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, go to www.Otrexup.com or call
1-855-OTREXUP (1-855-687-3987).
About Antares Pharma
Antares Pharma focuses on self-administered parenteral
pharmaceutical products and topical gel-based medicines. The
Company is developing VIBEX QS T for testosterone replacement
therapy. The Company's technology platforms include VIBEX®
disposable Medi-Jet®, disposable multi-use pen injectors and
VisionTM reusable needle-free injectors marketed as Tjet® and
Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring
Pharmaceuticals (Ferring), respectively. Antares Pharma has a
multi-product deal with Teva that includes Tev-Tropin® [somatropin
(rDNA origin) for injection] human growth hormone (hGH), VIBEX®
epinephrine and several other products. Antares Pharma’s
partnership with Ferring includes Zomacton® hGH (somatropin)
injection. In the U.S. Antares has received FDA approval for
Gelnique 3%TM (oxybutynin) gel, a treatment for overactive bladder
that is marketed by Actavis. Elestrin® (estradiol gel) is FDA
approved for the treatment of moderate-to-severe vasomotor symptoms
associated with menopause, and is marketed in the U.S. by Meda
Pharma. Antares Pharma has two facilities in the U.S. The
Parenteral Products Group located in Minneapolis, Minnesota directs
the manufacturing and marketing of the Company’s reusable
needle-free injection devices and related disposables, and develops
its disposable pressure-assisted MediJet and pen injector systems.
The Company’s corporate office and Product Development and
Commercial Groups are located in Ewing, New Jersey.
About Creaky Joints
CreakyJoints (http://www.CreakyJoints.org) is the world’s
leading arthritis support, education, advocacy and research
community for people with arthritis (RA, PsA, OA, and other
rheumatic diseases) as well as their caregivers. It is a part of
the non-profit Global Healthy Living Foundation
(http://www.GHLF.org). CreakyJoints was co-founded by arthritis
patient Seth Ginsberg in 1999, and today, has a reach of more than
25 million people per week, according to Facebook
(http://www.Facebook.com/CreakyJoints), making it the most popular.
GHLF and CreakyJoints work to create an environment where strength,
experience, and information can be exchanged to improve
quality-of-life through educational programs, supportive social
media, innovative research initiatives and nurtured collaborative
advocacy among other organizations. Membership within CreakyJoints
is free and encouraged for anyone who is impacted by arthritis.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements regarding the
potential benefits of OTREXUP and its consistent availability. Such
forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties that may cause actual
results to differ materially from those anticipated by the
forward-looking statements. These risks and uncertainties include,
among others, market acceptance by physicians and patients of new
products, difficulties or delays in the commercial launch of
OTREXUP, difficulties or delays in the manufacture, supply or
distribution of OTREXUP and changes or delays in the regulatory
process for existing or new product candidates. 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 for the year
ended December 31, 2012, 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.
Antares Pharma, Inc.Jack HowarthVice President, Corporate
Affairs609-359-3016jhowarth@antarespharma.comorMakovskyElaine
Andrecovich212-508-9675
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