XYOSTED™ AMBULATORY BLOOD PRESURE ABSTRACT
HAS BEEN SELECTED FOR POSTER PRESENTATION
Antares Pharma, Inc. (NASDAQ: ATRS) today announced that data from
the 26-week Phase 3 study of the safety and tolerability of
XYOSTED™ will be presented as a moderated poster presentation on
Friday November 9, 2018 at the 24th Annual Fall Scientific Meeting
of the Sexual Medicine Society of North America
(SMSNA).
Moderated Poster
Presentation
The poster entitled “Effect of Testosterone
Enanthate on 24-hour Ambulatory Blood Pressure is Less in Patients
with Hypertension at Baseline” will be presented by Mohit Khera,
MD, Laboratory for Andrology Research, Baylor College of Medicine,
Houston Tx. The submission was among a select group of key
abstracts awarded the distinction of a moderated poster
presentation.
The Phase 3, 26-week, dose-blind, multicenter
trial of XYOSTED, a proprietary, pre-filled subcutaneous
testosterone enanthate auto-injector administered weekly, examined
133 hypogonadal adult men with baseline testosterone (T) levels of
<300 ng/dL. Patients received 75 mg of testosterone
enanthate administered via auto injector once-weekly for 6 weeks.
At week 7, dose adjustments were conducted according to a simple
titration scheme if necessary and were based on week-6, pre-dose
blood levels in the patients. The XYOSTED™ clinical program
included a rigorous ambulatory blood pressure monitoring (ABPM)
study to fully characterize the potential side effects of
testosterone replacement on blood pressure.
The study endpoints included standard safety
evaluations plus 24-hour ambulatory blood pressure monitoring
(ABPM) in all patients. Overall compliance was >99%.
The study identified increases in systolic blood pressure (SBP)
from baseline to week 26 of 125.6 mmHg to 129.0 mmHg (3.4 mmHg) and
increases in diastolic blood pressure (DBP) from 78.2 mmHg at
baseline to 80.0 mmHg (1.8 mmHg) at week 26. Overall, 34 patients
experienced adverse drug reactions (ADRs) with the majority
considered mild or moderate. The most frequently reported ADRs were
increased hematocrit, injection site hemorrhage, injection site
bruising, and increased prostate-specific antigen.
Patients with hypertension at baseline appeared
to experience less impact on blood pressure following
treatment. Furthermore, those patients using antihypertensive
medications experienced comparable blood pressure changes as those
patients not on antihypertensive medications. Based upon the
data, blood pressure measurements do not demonstrate increased
susceptibility to testosterone therapy in patients with
hypertension at baseline or in those patients currently taking
antihypertensive medication.
Date: Friday November 9, 2018 –
1:55 p.m.Session: Moderated Poster Session:
AndrogensSession Time: 1:30 p.m.- 3:30 p.m.
Eastern Time Location: Loews Miami Beach,
Fl., Poinciana 3 & 4
For full prescribing information please visit
WWW.ANTARESPHARMA.COM
XYOSTED™ (testosterone enanthate) injection, for
subcutaneous use CIII
Initial US approval: 1953
IMPORTANT SAFETY
INFORMATION
BOXED WARNING: BLOOD PRESSURE
INCREASES
- XYOSTED™ can cause blood pressure increases that can
increase the risk for major adverse cardiovascular events (MACE),
including non-fatal myocardial infarction, non-fatal stroke and
cardiovascular death, with greater risk for MACE in patients with
cardiovascular risk factors or established cardiovascular
disease.
- Before initiating XYOSTED™, consider the patient’s
baseline cardiovascular risk and ensure blood pressure is
adequately controlled.
- Starting approximately 6 weeks after initiating
therapy, periodically monitor for and treat new-onset hypertension
or exacerbations of pre-existing hypertension in patients on
XYOSTED™.
- Re-evaluate whether the benefits of XYOSTED™ outweigh
its risks in patients who develop cardiovascular risk factors or
cardiovascular disease while on treatment.
- Due to this risk, use XYOSTED™ only for the treatment
of men with hypogonadal conditions associated with structural or
genetic etiologies.
XYOSTED™ INDICATIONS AND
USAGE
XYOSTED™ (testosterone enanthate) injection is
an androgen indicated for testosterone replacement therapy in adult
males for conditions associated with a deficiency or absence of
endogenous testosterone.
- Primary hypogonadism (congenital or acquired)
- Hypogonadotropic hypogonadism (congenital or acquired)
LIMITATIONS OF USE
- Safety and efficacy of XYOSTED™ in men with “age-related
hypogonadism” (also referred to as “late-onset hypogonadism”) have
not been established
- Safety and efficacy of XYOSTED™ in males less than 18 years old
have not been established
CONTRAINDICATIONS
XYOSTED™ is contraindicated in:
- Men with carcinoma of the breast or known or suspected
carcinoma of the prostate.
- Women who are pregnant. Testosterone can cause virilization of
the female fetus when administered to a pregnant woman.
- Men with known hypersensitivity to XYOSTED™ or any of its
ingredients (testosterone enanthate and sesame oil).
- Men with hypogonadal conditions, such as “age-related
hypogonadism”, that are not associated with structural or genetic
etiologies. The efficacy of XYOSTED™ has not been established for
these conditions, and XYOSTED™ can increase blood pressure (BP)
that can increase the risk of MACE.
WARNINGS AND PRECAUTIONS
Blood Pressure Increases—In
clinical trials, XYOSTED™ increased systolic BP in the first 12
weeks of treatment by an average of 4 mmHg based on ambulatory
blood pressure monitoring (ABPM) and by an average of 4 mmHg from
baseline following 1 year of treatment based on blood pressure cuff
measurements. In the 1-year trial, 10% of XYOSTED™-treated patients
were started on antihypertensive medications or required changes to
their antihypertensive medication regimen.
BP increases can increase the risk of MACE, with
greater risk in patients with established cardiovascular disease or
risk factors for cardiovascular disease.
In some patients, the increase in BP with
XYOSTED™ may be too small to detect, but can still increase the
risk for MACE.
Before initiating XYOSTED™, consider the
patient’s baseline cardiovascular risk and ensure blood pressure is
adequately controlled. Check BP approximately 6 weeks after
initiating XYOSTED™ and periodically thereafter. Treat new-onset
hypertension or exacerbations of pre-existing hypertension.
Re-evaluate whether the benefits of continued treatment with
XYOSTED™ outweigh its risks in patients who develop cardiovascular
risk factors or cardiovascular disease.
Polycythemia—Increases in
hematocrit, reflective of increases in red blood cell mass, may
require discontinuation of XYOSTED™. Check that hematocrit is not
elevated prior to initiating XYOSTED™. Evaluate hematocrit
approximately every 3 months while the patient is on XYOSTED™. If
hematocrit becomes elevated, stop XYOSTED™ until the hematocrit
decreases to an acceptable level. If XYOSTED™ is restarted and
again causes hematocrit to become elevated, stop XYOSTED™
permanently. An increase in red blood cell mass may increase the
risk of thromboembolic events.
Cardiovascular Risk—Long-term
clinical safety trials have not been completed to assess the
cardiovascular outcomes of testosterone replacement therapy in
adult males. To date, epidemiologic studies and randomized
controlled trials have been inconclusive for determining the risk
of MACE, such as non-fatal myocardial infarction, non-fatal stroke,
and cardiovascular death, with the use of testosterone compared to
non-use. Some studies, but not all, have reported an increased risk
of MACE in association with use of testosterone replacement therapy
in adult males. XYOSTED™ can cause BP increases that can increase
the risk of MACE. Patients should be informed of this possible risk
when deciding whether to use or to continue to use XYOSTED™.
Worsening of Benign Prostatic
Hyperplasia (BPH) and Potential Risk of Prostate
Cancer—Patients with BPH treated with androgens are at an
increased risk of worsening of signs and symptoms of BPH. Monitor
patients with BPH for worsening signs and symptoms. Patients
treated with androgens may be at an increased risk for prostate
cancer. Evaluate patients for prostate cancer prior to initiating
and during treatment with androgens.
Venous Thromboembolism
(VTE)—There have been post-marketing reports of venous
thromboembolic events, including deep vein thrombosis (DVT) and
pulmonary embolism (PE), in patients using testosterone products,
such as XYOSTED™. Evaluate patients who report symptoms of pain,
edema, warmth and erythema in the lower extremity for DVT and those
who present with acute shortness of breath for PE. If a venous
thromboembolic event is suspected, discontinue treatment with
XYOSTED™ and initiate appropriate workup and management.
Abuse of Testosterone and Monitoring of
Serum Testosterone Concentrations—Testosterone has been
subject to abuse, typically at doses higher than recommended for
the approved indication and in combination with other anabolic
androgenic steroids. Anabolic androgenic steroid abuse can lead to
serious cardiovascular and psychiatric adverse reactions.
If testosterone abuse is suspected, check serum
testosterone concentrations to ensure they are within therapeutic
range. However, testosterone levels may be in the normal or
subnormal range in men abusing synthetic testosterone derivatives.
Counsel patients concerning the serious adverse reactions
associated with abuse of testosterone and anabolic androgenic
steroids. Conversely, consider the possibility of testosterone and
anabolic androgenic steroid abuse in suspected patients who present
with serious cardiovascular or psychiatric adverse events.
Not for Use in Women—Due to
lack of controlled studies in women and potential virilizing
effects, XYOSTED™ is not indicated for use in women.
Potential for Adverse Effects on
Spermatogenesis—With large doses of exogenous androgens,
including XYOSTED™, spermatogenesis may be suppressed through
feedback inhibition of pituitary follicle-stimulating hormone (FSH)
which could possibly lead to adverse effects on semen parameters
including sperm count. Patients should be informed of this possible
risk when deciding whether to use or to continue to use
XYOSTED™.
Hepatic Adverse
Effects—Prolonged use of high doses of orally active
17-alpha-alkyl androgens (e.g., methyltestosterone) has been
associated with serious hepatic adverse effects (peliosis hepatis,
hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis
hepatis can be a life-threatening or fatal complication. Long-term
therapy with intramuscular testosterone enanthate, which elevates
blood levels for prolonged periods, has produced multiple hepatic
adenomas. XYOSTED™ is not known to produce these adverse effects.
Nonetheless, patients should be instructed to report any signs or
symptoms of hepatic dysfunction (e.g., jaundice). If these occur,
promptly discontinue XYOSTED™ while the cause is evaluated.
Edema—Androgens, including
XYOSTED™, may promote retention of sodium and water. Edema with or
without congestive heart failure may be a serious complication in
patients with preexisting cardiac, renal, or hepatic disease. In
addition to discontinuation of the drug, diuretic therapy may be
required.
Gynecomastia—Gynecomastia may
develop and may persist in patients being treated for
hypogonadism.
Sleep Apnea—Treatment with
testosterone products, including XYOSTED™, may potentiate sleep
apnea in some patients, especially those with risk factors such as
obesity or chronic lung disease.
Lipids—Changes in the serum
lipid profile may require dose adjustment of lipid lowering drugs
or discontinuation of testosterone therapy. Monitor the lipid
profile periodically, particularly after starting testosterone
therapy.
Hypercalcemia—Androgens,
including XYOSTED™, should be used with caution in cancer patients
at risk of hypercalcemia (and associated hypercalciuria). Monitor
serum calcium concentrations regularly during treatment with
XYOSTED™ in these patients.
Decreased Thyroxine-binding
Globulin—Androgens, including XYOSTED™, may decrease
concentrations of thyroxine-binding globulin, resulting in
decreased total T4 serum concentrations and increased resin uptake
of T3 and T4. Free thyroid hormone concentrations remain unchanged,
however, and there is no clinical evidence of thyroid
dysfunction.
Risk of Depression and
Suicide—Depression and suicidal ideation and behavior,
including completed suicide, have occurred during clinical trials
in patients treated with XYOSTED™. Advise patients and caregivers
to seek medical attention for manifestations of suicidal ideation
or behavior, new onset or worsening depression, anxiety, or other
mood changes.
ADVERSE REACTIONSThe safety of
XYOSTED™ was evaluated in 2 clinical studies in a total of 283 men
who received weekly subcutaneous doses for up to 1 year. All
patients were started on 75 mg weekly, then the dose was titrated
to 50 mg or 100 mg weekly, as needed, to achieve pre-dose total
testosterone concentrations of ≥350 ng/dL and <650 ng/dL.
The most commonly reported adverse reactions
(>5%) were: hematocrit increased, hypertension, PSA increased,
injection site bruising, and headache.
DRUG INTERACTIONS
Insulin—Changes in insulin
sensitivity or glycemic control may occur in patients treated with
androgens. In diabetic patients, the metabolic effects of androgens
may decrease blood glucose and, therefore, may necessitate a
decrease in the dose of anti-diabetic medication.
Oral Anticoagulants—Changes in
anticoagulant activity may be seen with androgens, therefore, more
frequent monitoring of international normalized ratio (INR) and
prothrombin time are recommended in patients taking warfarin,
especially at the initiation and termination of androgen
therapy.
Corticosteroids—The concurrent
use of testosterone with corticosteroids may result in increased
fluid retention and requires careful monitoring, particularly in
patients with cardiac, renal or hepatic disease.
Medications that May Also Increase Blood
Pressure—Some prescription medications and nonprescription
analgesic and cold medications contain drugs known to increase
blood pressure. Concomitant administration of these medications
with XYOSTED™ may lead to additional increases in blood
pressure.
USE IN SPECIFIC
POPULATIONSPregnancy—XYOSTED™ is
contraindicated in pregnant women. Testosterone is teratogenic and
may cause fetal harm when administered to a pregnant woman based on
data from animal studies and its mechanism of action. Exposure of a
female fetus to androgens may result in varying degrees of
virilization. In animal developmental studies, exposure to
testosterone in utero resulted in hormonal and behavioral changes
in offspring and structural impairments of reproductive tissues in
female and male offspring. These studies did not meet current
standards for nonclinical development toxicity studies.
Lactation—XYOSTED™ is not
indicated for use in females.
Females and Males of Reproductive
Potential - During treatment with large
doses of exogenous androgens, including XYOSTED™, spermatogenesis
may be suppressed through feedback inhibition of the
hypothalamic-pituitary-testicular axis. Reduced fertility is
observed in some men taking testosterone replacement therapy. The
impact on fertility may be irreversible.
Pediatric
Use—Safety and effectiveness of XYOSTED™ in
pediatric patients less than 18 years old have not been
established. Improper use may result in acceleration of bone age
and premature closure of epiphyses.
Geriatric
Use—There have not been sufficient numbers of
geriatric patients in controlled clinical studies with XYOSTED™ to
determine whether efficacy or safety in those over 65 years of age
differs from younger subjects. Of the 283 patients enrolled in the
6-month and 1-year efficacy and safety clinical study utilizing
XYOSTED™, 49 (17%) were over 65 years of age. Additionally, there
are insufficient long-term safety data in geriatric patients to
assess the potentially increased risk of cardiovascular disease and
prostate cancer. Geriatric patients treated with androgens may also
be at risk for worsening of signs and symptoms of BPH.
DRUG ABUSE AND DEPENDENCE
XYOSTED™ contains testosterone enanthate, a
Schedule III controlled substance in the Controlled Substances
Act.
Abuse and misuse of testosterone are seen in
male and female adults and adolescents. Testosterone, often in
combination with other anabolic androgenic steroids, may be abused
by athletes and bodybuilders.
Serious adverse reactions have been reported in
individuals who abuse anabolic androgenic steroids, and include
cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy,
congestive heart failure, cerebrovascular accident, hepatotoxicity,
and serious psychiatric manifestations, including major depression,
mania, paranoia, psychosis, delusions, hallucinations, hostility,
and aggression.
The following adverse reactions have been
reported in men: transient ischemic attacks, convulsions,
hypomania, irritability, dyslipidemia, testicular atrophy,
subfertility, and infertility.
The following adverse reactions have been
reported in women: hirsutism, virilization, deepening of voice,
clitoral enlargement, breast atrophy, male pattern baldness, and
menstrual irregularities.
The following adverse reactions have been
reported in male and female adolescents: premature closure of bony
epiphyses with termination of growth, and precocious puberty.
Withdrawal symptoms can be experienced upon
abrupt discontinuation in patients with addiction. Withdrawal
symptoms include depressed mood, major depression, fatigue,
craving, restlessness, irritability, anorexia, insomnia, decreased
libido, and hypogonadotropic hypogonadism. Drug dependence in
individuals using approved doses for approved indications have not
been documented.
For more information, call 1-844-XYOSTED
(1-844-996-7833).Please see full Prescribing Information, including
Boxed Warning and Medication Guide.
About HypogonadismHypogonadism, 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 SMSNA
Established in 1994, the Sexual Medicine Society
of North America’s objective has been to promote, encourage, and
support the highest standards of practice, research, education, and
ethics in the study of the anatomy, physiology, pathophysiology,
diagnosis, and treatment of human sexual function and dysfunction.
Further, SMSNA provides a forum for the free exchange and
discussion of new ideas, thoughts, and concepts in sexual medicine.
Consisting of over 700 active members, the organization is composed
of North American surgeons, physicians, mental health
professionals, scientists, residents and medical students all
committed to sexual health. The SMSNA seeks to identify
existing and emerging issues in the field of human sexual function
and dysfunction, provide accurate and credible information to
medical professionals, develop standards and guidelines for SEXUAL
MEDICINE research and practice, and produce educational programs
that bring leading-edge concepts of research, clinical practice,
ethics, and politics to health care professionals interested in
SEXUAL MEDICINE and related matters.
About Antares Pharma
Antares Pharma, Inc. is a specialty
pharmaceutical company focused 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
advanced stages of development, as well as significant strategic
alliances with industry leading pharmaceutical companies including
Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals,
Inc. and Pfizer Inc. (Pfizer). 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: market acceptance,
adequate reimbursement coverage and commercial success of XYOSTED™
and future revenue from the same; market acceptance, adequate
reimbursement coverage and commercial success of Teva’s generic
epinephrine auto-injector product and future revenue from the same;
future market acceptance and revenue from AMAG’s 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®; successful completion of the asset sale
transaction with Ferring International Center, S.A.; the timing and
results of the Company’s or its partners’ research projects or
clinical trials of product candidates in development including
projects with Teva and Pfizer; 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; 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.
Contact:
Jack HowarthVice President, Corporate Affairs of
Antares609-359-3016jhowarth@antarespharma.com
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