Commercial launch expands Endo's growing branded
pharmaceutical men's health portfolio
DUBLIN, March 16, 2015 /PRNewswire/ -- Endo
Pharmaceuticals Inc., a subsidiary of Endo International plc
(NASDAQ: ENDP) (TSX: ENL), announced today the commercial
availability of NATESTO™ (testosterone nasal gel), the first and
only nasal gel for testosterone replacement therapy in adult males
diagnosed with hypogonadism.
NATESTO™ was approved by the U.S. Food and Drug Administration
(FDA) in May 2014 for replacement
therapy in adult men with conditions associated with deficiency or
absence of endogenous testosterone, including primary hypogonadism
(congenital or acquired) or hypogonadotropic hypogonadism
(congenital or acquired). NATESTO™ reduces the risk of
transference via intranasal application.
"The launch of NATESTO™ further expands Endo's branded portfolio
of men's health treatment offerings and highlights our continuing
commitment to ensuring that patients living with hypogonadism have
access to high quality medicines," said Rajiv De Silva,
President and CEO of Endo. "With testosterone gels,
implantable testosterone pellets, a long-acting injectable, and now
an intranasal gel, Endo offers healthcare professionals a broad
range of delivery options to appropriately raise testosterone
levels that help meet the individual needs of men living with
hypogonadism."
In 2014, Endo acquired the rights to NATESTO™ in the U.S. and
Mexico from Trimel BioPharma SRL,
a wholly-owned subsidiary of Trimel Pharmaceuticals Corporation
(TSX: TRL), for $25 million plus
additional payments upon the achievement of certain regulatory and
sales milestones. Endo will collaborate with Trimel on all
regulatory and clinical development activities regarding
NATESTO™.
About NATESTO™ (testosterone) Nasal Gel
NATESTO™ is an androgen indicated for replacement therapy in
males for conditions associated with a deficiency or absence of
endogenous testosterone including:
- Primary hypogonadism (congenital or acquired)
- Hypogonadotropic hypogonadism (congenital or acquired)
Limitations of Use
- Safety and efficacy of NATESTO™ in males less than 18 years old
have not been established
Dosage
NATESTO™ for intranasal use is available as a metered-dose
pump. One pump actuation delivers 5.5 mg of testosterone. The
recommended dose of NATESTO™ is 11 mg of testosterone (two pump
actuations, one per nostril), applied intranasally three times
daily for a total daily dose of 33 mg.
Contraindications
- Men with carcinoma of the breast or known or suspected prostate
cancer
- Pregnant or breast-feeding women. Testosterone may cause fetal
harm.
Warnings and Precautions
- Nasal adverse reactions: nasal signs and symptoms should
be monitored. NATESTO™ is not recommended for use in patients
with chronic nasal conditions or alterations in nasal anatomy
- Monitor patients with benign prostatic hyperplasia (BPH) for
worsening of signs and symptoms of BPH
- Venous thromboembolism (VTE), including deep vein thrombosis
(DVT) and pulmonary embolism (PE) have been reported in patients
using testosterone products. Evaluate patients with signs or
symptoms consistent with DVT or PE
- Women and children should not use Natesto™
- Exogenous administration of androgens may lead to
azoospermia
- Edema with or without congestive heart failure (CHF) may be a
complication in patients with preexisting cardiac, renal, or
hepatic disease
- Sleep apnea may occur in those with risk factors
- Monitor serum testosterone, prostate-specific antigen (PSA),
hemoglobin, hematocrit, liver function tests, and lipid
concentrations periodically
Adverse Reactions
The most common adverse reactions (incidence >/=3%) to NATESTO™ observed in clinical
trials were an increase in prostate specific antigen (PSA),
headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis,
bronchitis, upper respiratory tract infection, sinusitis and nasal
scab.
Click here for full prescribing Information for NATESTO or visit
www.endo.com/File%20Library/Products/Prescribing%20Information/Natesto_prescribing_information.html.
About Endo International plc
Endo International plc is a global specialty healthcare company
focused on improving patients' lives while creating shareholder
value. Endo develops, manufactures, markets, and distributes
quality branded pharmaceutical, generic pharmaceutical, over the
counter medications and medical device products through its
operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in
Malvern, PA. Learn more at
www.endo.com.
About Endo Pharmaceuticals Inc.
Endo Pharmaceuticals Inc. is focused on developing and
delivering high-value branded pharmaceutical products that meet the
unmet needs of patients. Endo Pharmaceuticals is an operating
company of Endo International plc (NASDAQ: ENDP) (TSX: ENL), a
global specialty healthcare company focused on improving patients'
lives while creating shareholder value. Learn more at
www.endo.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
and Canadian securities legislation. Statements including words
such as "believes," "expects," "anticipates," "intends,"
"estimates," "plan," "will," "may," "look forward," "intend,"
"guidance," "future" or similar expressions are forward-looking
statements. Because these statements reflect Endo's current views,
expectations and beliefs concerning future events, these
forward-looking statements involve risks and uncertainties.
Although Endo believes that these forward-looking statements and
information are based upon reasonable assumptions and expectations,
readers should not place undue reliance on them, or any other
forward-looking statements or information in this news release.
Investors should note that many factors, as more fully described in
the documents filed by Endo with securities regulators in
the United States and Canada including under the caption "Risk
Factors" in Endo's Form 10-K, and Endo's Form 10-Q and Form 8-K
filings, as applicable, with the Securities and Exchange Commission
and by Endo with securities regulators in Canada on the System for Electronic Document
Analysis and Retrieval ("SEDAR") and as otherwise enumerated herein
or therein, could affect Endo's future financial results and could
cause Endo's actual results to differ materially from those
expressed in forward-looking statements contained in Endo's Annual
Report on Form 10-K. The forward-looking statements in this press
release are qualified by these risk factors. These are factors
that, individually or in the aggregate, could cause Endo's actual
results to differ materially from expected and historical results.
Endo assumes any obligation to publicly update any forward-looking
statements, whether as a result of new information, future
developments or otherwise, except as may be required under
applicable securities law.
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SOURCE Endo International plc