Australian company, Acrux, today announced positive results from
a Phase III trial evaluating the safety and efficacy of AXIRON™ in
155 men with testosterone deficiency (hypogonadism), across 26
sites in six countries.
AXIRON™ is applied to the underarm using a unique “no-touch”
applicator. Upon approval, AXIRON™ would be the first and only
pharmaceutical product applied to the armpit - in much the same way
as an antiperspirant. As well as existing patents that protect
AXIRON™ to 2017, Acrux has a new patent that, when granted, will
extend protection of this novel, class-leading feature until
2026.
Phase III trial results
The trial met its primary endpoint by demonstrating that after
four months of treatment with
AXIRON™, 84 percent of subjects achieved average blood levels of
testosterone within the normal range, exceeding the requirement of
75 percent that was agreed upon by the U.S. Food and Drug
Administration (FDA).
After only two weeks of
treatment, it was found that 76 percent of subjects had average
blood levels of testosterone within the normal range.
The average testosterone level for the responder group after 120
days treatment with AXIRON™ was 504ng/dl (the normal range being
300-1,050ng/dl). The average baseline testosterone level in
subjects prior to treatment was 190ng/dl.
Four different dose levels of AXIRON™ were tested, and the trial
demonstrated that the optimum dose for 75 percent of subjects was
60mg testosterone per day, equivalent to one single application of
AXIRON™ to each armpit.
Subjects were permitted to use an underarm deodorant or
antiperspirant during the trial. More than half of the men
continued to apply an underarm deodorant or antiperspirant as part
of their daily routine, and an analysis of these subgroups showed
that this had no impact on the efficacy of AXIRON™ treatment.
Analysis of mood, sexual desire, sexual activity and sexual
performance before and after four months of treatment showed
significant improvement from baseline across all measures.
There were no serious adverse events related to treatment with
AXIRON™ and no adverse trends were identified with the biochemical
safety measures, including prostate specific antigen, haematocrit,
and the ratio of dihydrotestosterone to testosterone.
Fifty-two men continued treatment for an additional two months
specifically to monitor skin safety with six months of continuous
use. Eight subjects reported some form of transient application
site reaction during the main treatment phase of four months;
however, these reported events were all mild or moderate and
resolved quickly without any intervention. No patient withdrew due
to a skin reaction.
“In terms of the proportion of responders to testosterone
replacement using AXIRON™, the pharmacokinetic parameters and the
response from this multi-center clinical trial, the results are
very exciting and precisely what we had hoped to see,” commented
lead investigator Professor Christina Wang, MD, at Los Angeles
Biomedical Research Institute and Professor of Medicine at David
Geffen School of Medicine at UCLA. “The post-treatment changes
demonstrated positive responses in sexual desire, sexual activity,
mood and general well-being, underpinning the patient- reported
benefits of this treatment. Patient compliance and acceptance of
the unique no-touch axilla application technique was very good, as
evidenced by the high completer rate,” added Professor Wang.
Earlier this month, Acrux announced it had held a pre-NDA
meeting with the FDA in Washington, DC and the FDA had agreed Acrux
may proceed to file a New Drug Application (NDA) in the United
States, which Acrux is targeting for the end of 2009.
Acrux has already received strong interest from a number of
potential marketing partners for AXIRON™. Following release of the
Phase III trial results, formal partnering discussions with
interested parties will be progressed in October 2009.
If approved by the FDA, market entry for AXIRON™ could occur in
early 2011, and may play an important role in the treatment of
patients living with hypogonadism. Based on IMS data, global sales
in this market for the year to March 2009 exceeded U.S. $1 billion
for the first time, and sales in the U.S. market grew by more than
20 percent. Sales of testosterone gels in the U.S. grew to U.S.
$0.7 billion for the year to March 2009.
Last year Acrux published results from market research conducted
in both patients and physicians in the USA, in which two thirds of
patients confirmed that they would prefer AXIRON™ to their existing
gel treatment and 87 percent of physicians said that they would
offer AXIRON™ to their patients that currently use gels.
Importantly, 94 percent of patients who tried AXIRON™ rated it
better than the testosterone gels in its ability to reduce the risk
of transference of testosterone to others. In addition, 92 percent
of physicians surveyed who prescribe gels as first line therapy
rated AXIRON™ as very good or excellent in its ability to reduce
the risk of transference to others when compared to the gels.
“We are excited by the AXIRON™ Phase III trial results and are
now well positioned to submit our NDA by the end of 2009,” said Dr.
Richard Treagus, CEO and Managing Director of Acrux. “These
results, along with our recent meeting with the FDA, place us in a
strong position as we initiate a process to select marketing
partners for what is a unique testosterone delivery system that we
believe will be a patient preferred treatment for hypogonadal men,”
he said.
About AXIRON™ (testosterone solution)
2%
Testosterone deficiency in men (hypogonadism) is associated with
a number of symptoms including lethargy, depression, reduced libido
and decrease in muscle mass and bone density. Estimates of men over
50 years of age having testosterone levels below the normal healthy
range vary from 10 percent to 39 percent1. However, in the majority
of men this remains undiagnosed, with only around five percent to
10 percent of those with the condition receiving treatment. With a
high incidence rate and low but growing treatment rates, the male
testosterone deficiency market will remain an attractive commercial
opportunity. AXIRON™ has been designed to overcome the significant
issues and drawbacks associated with the current gel treatments.
Large volumes of gel are applied by hand and rubbed on to the
abdomen, shoulders or arms. They are considered messy, sticky,
slow-drying and may have an unpleasant odour to some patients. One
of the biggest drawbacks is the risk of transference to other
people through contact with the application site or from residue
left on the hands following application. AXIRON™ is a faster-drying
and pleasant smelling solution that is applied to the armpits once
daily, using a convenient and ergonomic “no-touch” applicator
designed in Australia. The armpit is a unique application site for
transdermal drug delivery and it offers significant advantages to
the patient in terms of convenience and may have a lower risk of
transference from patient to others. A factsheet on AXIRON™ is
available for download at www.acrux.com.au.
About Acrux (ASX: ACR) - www.acrux.com.au
- Acrux is an Australian drug
delivery company, developing and commercialising a range of
patient-preferred, patented pharmaceutical products for global
markets, using its innovative technology to administer drugs
through the skin.
- Fast-drying, invisible sprays or
liquids provide a delivery platform with low or no skin irritation,
superior cosmetic acceptability and simple, accurate and flexible
dosing. The technology platform is covered by broad and
well-differentiated, issued patents.
- Acrux has one product, Evamist™
(brand name Ellavie™ outside the U.S.A.) to treat menopause
symptoms, marketed by its licensee in the U.S.A. and has the
following products in clinical development:
- AXIRON™ to treat testosterone
deficiency in men
- Testosterone MDTS® to treat
decreased libido in women
- Nestorone® MDTS® contraceptive
sprays for women
- An undisclosed companion animal
health product
- Nicotine MDTS® for smoking
cessation
- Acrux has licensed U.S. rights
for Evamist™ to KV Pharmaceutical and has appointed distributors
for Ellavie™ in nine European countries and in Southern Africa,
South Korea and Australia. Acrux has also licensed its technology
to Eli Lilly and Company for veterinary healthcare products, U.S.
rights for Testosterone MDTS® to VIVUS, and has an exclusive
alliance with Orion Corporation for commercial product supply.
1 Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C.
Prevalence of hypogonadism in males aged at least 45 years: the HIM
study. Int J Clin Pract. 2006;60(7):762-769
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