TORONTO, May 28, 2014 /PRNewswire/ -- 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