Natesto™ is the first nasal testosterone replacement therapy
approved by FDA
TORONTO, May 28, 2014 /CNW/ - Trimel Pharmaceuticals
Corporation (TSX: TRL) announced today that the United States Food
and Drug Administration (FDA) has approved Natesto™ (testosterone),
formerly CompleoTRT™, the first and only testosterone nasal gel for
replacement therapy in adult males for conditions associated with a
deficiency or absence of endogenous testosterone. Natesto™ is
self-administered via a nasal applicator thereby minimizing the
risk of secondary exposure to testosterone of women or
children.
"In my practice I regularly encounter men
demonstrating symptoms of hypogonadism and physicians will
increasingly see this as the North American population ages," said
Dr. Jeffrey Rosen, the medical
director and founder of Clinical Research of South Florida (CRSA). "For these patients
seeking to restore their testosterone levels, Natesto™ will offer
an alternative delivery system that is safer and more convenient
than the other options currently available on the market."
It is conservatively estimated that nearly 13
million American men may have low testosterone levels.
Current treatment guidelines focus on the restoration of the
physiological testosterone level through the use of exogenous
testosterone preparations, which include topical gels applied by
the hands, subcutaneous pellets, transdermal patches, intramuscular
injections, oral tablets, as well as a buccal patch.
"The FDA approval for Natesto™ is a major
achievement for our company, as it validates our clinical research
and development efforts, as well as reinforces our commitment to
provide innovative treatment options for patients," said
Tom Rossi, Trimel Pharmaceuticals
Corporation President and CEO. "Men suffering from "Low T" will now
have a different option to raise their testosterone levels.
This novel route of administration will enable men to take this
therapy in mere seconds, without worrying about the risk associated
with transferring the product to women or children. We are
now focused on getting Natesto™ to market as expeditiously as
possible so that appropriate patients can have access to it."
About Male Hypogonadism
Male hypogonadism, or low testosterone, is a
condition in which the testicles, hypothalamus or pituitary gland
is affected by disease or damage that results in inhibiting hormone
and testosterone secretion. Signs and symptoms associated with male
hypogonadism include erectile dysfunction and decreased sexual
desire, fatigue and loss of energy, depressed mood, osteoporosis
and regression of secondary sexual characteristics.
About Natesto™ (testosterone) Nasal
Gel
Indications and Usage
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™
- Edema with or without congestive heart failure (CHF) may be a
complication in patients with preexisting cardiac, renal, or
hepatic disease
- Exogenous administration of androgens may lead to
azoospermia
- 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.
About the Natesto™ Phase III Study
Natesto™ was evaluated in a multicenter,
open-label, 90-day Phase III trial that enrolled 306 hypogonadal
men at 39 clinical research centers in the United States. The mean age of patients
was 54 years with a range of 28 to 80 years. Of the 306 patients,
271 (89%) were Caucasian, 18 (6%) were African-American, 16 (5%)
were Asian, and 1 (less than 1%) had race recorded as "Other."
Patients were instructed to administer Natesto™ intranasally.
During the Natesto™ treatment period (Days 1 to 90), 78 patients
were treated with 33 mg of testosterone daily. Of these, a
total of 73 men were included in the statistical evaluation of
efficacy on Day 90 based on the intent-to-treat (ITT) population
with last observation carried forward (LOCF). Ninety percent
(90%) of these patients had Cavg within the normal range
(300 to 1050 ng/dL) on Day 90. The percentage of patients
with Cavg below the normal range (less than 300 ng/dL)
on Day 90 was 10% and no subject had a Cavg value
exceeding 1050 ng/dL.
About Trimel
Trimel is a specialty pharmaceutical company
actively developing medications for male hypogonadism, female
sexual dysfunction and various respiratory disorders. For more
information, please visit www.trimelpharmaceuticals.com.
Notice regarding forward-looking
statements:
Information in this press release that is not
current or historical factual information may constitute
forward-looking information within the meaning of securities laws.
Implicit in this information are assumptions regarding our future
operational results. These assumptions, although considered
reasonable by the company at the time of preparation, may prove to
be incorrect. Readers are cautioned that actual performance of the
company is subject to a number of risks and uncertainties,
including the ability of the company to successfully commercialize
Natesto™, and could differ materially from what is currently
expected as set out above. For more exhaustive information on these
risks and uncertainties you should refer to our annual information
form dated March 5, 2014 which is
available at www.sedar.com. Forward-looking information
contained in this press release is based on our current estimates,
expectations and projections, which we believe are reasonable as of
the current date. You should not place undue importance on
forward-looking information and should not rely upon this
information as of any other date. While we may elect to, we are
under no obligation and do not undertake to update this information
at any particular time, whether as a result of new information,
future events or otherwise, except as required by applicable
securities law.
SOURCE Trimel Pharmaceuticals Corporation
Image with caption: "Natesto Testosterone Nasal Gel (CNW
Group/Trimel Pharmaceuticals Corporation)". Image available at:
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