TORONTO (May 28,
2014) – 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 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.Posted By:
Ankita Nagpal
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