Antares Pharma, Inc. (NASDAQ: ATRS) today announced subcutaneous
methotrexate delivered with a new, self-administration device
demonstrates bioavailability that is significantly greater than
oral methotrexate in the treatment of adults with rheumatoid
arthritis. The clinical study results were presented at the 2013
European League Against Rheumatism (EULAR) Annual Congress.
The data are from a randomized, open-label, three-way crossover
study that found four hours after dose, blood concentrations of
subcutaneously, self-administered methotrexate were consistently
higher than concentrations of orally dosed methotrexate at all
levels studied.
Oral methotrexate exposure plateaued at doses of 15 mg and
higher, whereas self-administered subcutaneous methotrexate did not
plateau, with exposure continuing to increase at each dose. Study
investigators concluded that this resulted in higher systemic
exposure than the same oral dose, which may have important clinical
implications.
“These results represent a significant step forward in exploring
the optimization of methotrexate, the disease modifying
anti-rheumatic drug most commonly used as first-line for treatment
for rheumatoid arthritis around the world,” said Michael H. Schiff,
M.D., Clinical Professor of Medicine in the Rheumatology Division
at the University of Colorado School Of Medicine in Denver.
“Administering methotrexate subcutaneously translates to linear
dose absorption which may improve the efficacy of subcutaneous
methotrexate compared to oral therapy. This improved efficacy has
been previously reported in the literature and observed in clinical
practice.1”
The self-administration device is one component of an
investigational product under review by the Food and Drug
administration that combines the proprietary VIBEX™ auto-injection
delivery device with an injectable version of methotrexate, the
drug long regarded as the standard of care in the treatment of
rheumatoid arthritis.
The study of fifty adults compared the bioavailability of
methotrexate administered using the investigational
self-administration device-drug combination product relative to
that of the bioavailability of orally dosed methotrexate. It also
assessed the safety of the first-in-class delivery system.
Four hours after dosing, mean systemic concentration was
consistently higher in patients who received subcutaneously
self-administered methotrexate compared with those who received
oral methotrexate. The concentration of MTX in the
self-administration subcutaneous group was greater at all dose
levels (10mg, 15 mg, 20mg, or 25 mg) than in the group receiving
oral drug, as measured by pharmacokinetic parameters.
Relative bioavailability of subcutaneous methotrexate delivered
with the self-administration device at 10, 15, 20, and 25mg/0.4ml
was 121 percent, 114 percent, 131 percent and 141 percent compared
with oral dosing, respectively.
Peak concentration increased in a dose-proportional manner for
patients in the self-administration subcutaneous group compared
with oral MTX. The relative bio-availability of MTX, as measured by
the area under the concentration curve, was substantially improved
for patients randomized to receive subcutaneous treatment with the
self-administration device. The ratio of the dose-normalized area
under the concentration curve over a 24-hour period and maximum
observed concentration compared with oral MTX was 127.61 (90
percent CI: 122.30-133.15) and 94.88 (90 percent CI: 87.95-103.37),
respectively.
“The data presented earlier today suggests there is an
opportunity to increase the use of subcutaneous methotrexate which
we are developing as OTREXUP™, in patients with rheumatoid
arthritis or psoriasis in the U.S.,” said Paul Wotton, Ph.D.,
President and Chief Executive Officer. “We believe that one of the
reasons for the under-utilization of subcutaneous methotrexate may
be the absence of an easy-to-use device for self-administration.
These new data for self-administered subcutaneous methotrexate
provide support for extending the use of methotrexate in rheumatoid
arthritis and psoriasis patients.”
About the Study
This randomized, open-label, 3-way crossover study was conducted
over a 12-week period in 49 patients over the age of 18 with
rheumatoid arthritis. Of 50 randomized patients, 49 were dosed and
included in the safety population. Forty-seven patients completed
the study; all patients were undergoing treatment with MTX for
three or more months prior to randomization.
The primary objective of the study was to compare the relative
bioavailability of methotrexate after oral administration with that
of subcutaneous administration using the investigational delivery
device. Over 12-weeks, two serious adverse events occurred, neither
of which was considered to be treatment-related by the
investigator. Treatment in both the oral methotrexate and
subcutaneous methotrexate arms of the study were generally well
tolerated. Five patients (10.2 percent) had a treatment-emergent
adverse event; one patient in the oral MTX group experienced mild
and transient nausea. Some patients in the delivery device group
had slight to barely perceptible erythema at the injection site
after administration. No patients experienced bleeding, ecchymosis,
or hematoma at the injection site or required countermeasures
during the study. No patients discontinued the study because of an
injection site reaction.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral
pharmaceutical products and topical gel-based medicines. The
Company is developing OTREXUP™, a combination product for the
delivery of methotrexate using Medi-Jet™ technology for the
treatment of rheumatoid arthritis, poly-articular-course juvenile
rheumatoid arthritis and psoriasis, as well as VIBEX™ QS T for
testosterone replacement therapy. The Company's technology
platforms include VIBEX™ disposable Medi-Jet™, disposable multi-use
pen injectors and Vision™ reusable needle-free injectors marketed
as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva)
and Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma
has a multi-product deal with Teva that includes Tev-Tropin® human
growth hormone (hGH), VIBEX™ epinephrine and several other
products. Antares Pharma’s partnership with Ferring includes
Zomacton® hGH. In the U.S. Antares has received FDA approval for
Gelnique 3%™, a treatment for overactive bladder that is marketed
by Actavis. Elestrin® (estradiol gel) is FDA approved for the
treatment of moderate-to-severe vasomotor symptoms associated with
menopause, and is marketed in the U.S. by Meda Pharma. Antares
Pharma has two facilities in the U.S. The Parenteral Products Group
located in Minneapolis, Minnesota directs the manufacturing and
marketing of the Company’s reusable needle-free injection devices
and related disposables, and develops its disposable
pressure-assisted Medi-Jet and pen injector systems. The Company’s
corporate office and Product Development and Commercial Groups are
located in Ewing, New Jersey.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. These statements are indicated by
the words “may,” “will,” “plans,” “intends,” “believes,” “expects,”
“anticipates,” “potential,” “could,” “would,” “should,” and similar
expressions. Such forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties that
may cause actual results to differ materially from those
anticipated by the forward-looking statements. These risks and
uncertainties include, among others, changes in revenue growth and
difficulties or delays in the initiation, progress, or completion
of product development. In addition, the OTREXUP™ product referred
to in this press release has not yet been approved by the FDA, and
the commercialization of OTREXUP™ is dependent on the Company
receiving FDA approval of this product. Additional information
concerning these and other factors that may cause actual results to
differ materially from those anticipated in the forward-looking
statements is contained in the "Risk Factors" section of the
Company's Annual Report on Form 10-K for the year ended December
31, 2012, and in the Company's other periodic reports and filings
with the Securities and Exchange Commission. The Company cautions
investors not to place undue reliance on the forward-looking
statements contained in this press release. All forward-looking
statements are based on information currently available to the
Company on the date hereof, and the Company undertakes no
obligation to revise or update these forward-looking statements to
reflect events or circumstances after the date of this press
release, except as required by law.
1. Braun J, Kastner P, Flaxenberg P, et al; for the
MC-MTX.6/RH Study Group. Comparison of the clinical efficacy and
safety of subcutaneous versus oral administration of methotrexate
in patients with active rheumatoid arthritis: results of a
six-month, multicenter, randomized, double-blind, controlled, phase
IV trial. Arthritis Rheum. 2008; 58(1):73-81.
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