Kos Reports Summary Results from Clinical Study on Benefits of Combining Aspirin with Optimized Niaspan(R) CF
25 Juli 2006 - 4:39PM
Business Wire
Kos Pharmaceuticals, Inc. (Nasdaq:KOSP): -- The study shows that
2000 mg of optimized Niaspan(R) CF, when given with aspirin,
results in approximately 44% reduction in the incidence, duration
and severity of flushing relative to optimized Niaspan CF alone --
The study results are in addition to previously reported decreases
in flushing severity and duration when comparing optimized Niaspan
CF to currently available Niaspan in the absence of aspirin -- A
supplemental New Drug Application for a complete dosage range of
new Niaspan CF products was recently submitted to the Food and Drug
Administration -- Additional longer term and confirmatory studies
are planned Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) today announced
results from a study that demonstrates the benefits of combining
aspirin with its new optimized Niaspan(R) (niacin extended-release
tablets) Caplet Formulation (CF). This study was a single-dose,
placebo-controlled three-way crossover, flush provocation study
(N=156) evaluating the benefits of aspirin in combination with a
maximum dose of optimized Niaspan CF for reducing the incidence,
duration and severity of flushing, a relatively common, but
transient effect for patients who take Niaspan to increase HDL-C,
or "good" cholesterol. In this flush provocation study, subjects
were administered 650 mg of aspirin either 30 minutes before or at
the same time as a single dose of 2000 mg of optimized Niaspan CF.
Results show statistically significant reductions in the incidence
(number of subjects reporting a flush) and intensity of flushing,
compared to placebo administration. Flushing symptoms and duration
data were recorded in an electronic diary. Even though the study
was specifically designed to provoke flushing by administering 2000
mg of optimized Niaspan CF to treatment-naive subjects, only about
one-half of the subjects reported a flush with optimized Niaspan CF
plus aspirin. In addition, the flushing that did occur was
generally reported to be mild. Flushing duration was also reduced.
There were no significant differences in the incidence, duration or
severity of flushing when aspirin was administered either 30
minutes prior to, or simultaneous with, the dosing of optimized
Niaspan CF. Other characteristics of flushing including redness,
warmth, tingling and itching, were all also reduced with optimized
Niaspan CF and aspirin compared to placebo. "Data from this study
represents the latest output from a long term, multifaceted
development program initiated several years ago which was designed
to enhance the tolerability of Niaspan by capitalizing on Kos'
expertise, knowledge and strengths in reformulation and product
development," said Adrian Adams, President and CEO of Kos
Pharmaceuticals. "The benefits of aspirin in reducing
niacin-induced flushing have been known for many years, and so the
next stage in the natural evolution and life-cycle management of
our HDL boosting franchise was to test the combination of aspirin
with the new optimized Niaspan CF, a reformulation of Niaspan that
was recently shown in a previously announced clinical study to
decrease the severity and duration of flushing by around 42%." He
continued, "Furthermore, aspirin use is well established and is not
known to be associated with adverse cardiovascular side effects
that have recently come to light with some other, non-aspirin
nonsteroidal anti-inflammatory agents." Kos recently announced the
submission of a supplemental New Drug Application for a complete
dosage range of Niaspan CF products for review to the U.S. Food and
Drug Administration. The Company is planning for a first quarter
2007 launch of the new range of Niaspan CF products. About Niaspan
Available since 1997, Niaspan is the only FDA-approved, once-daily
extended-release prescription formulation of niacin for treating
abnormal cholesterol levels. Niaspan is indicated as an adjunct to
diet when the response to a diet restricted in saturated fat and
cholesterol and other nonpharmacologic measures alone has been
inadequate, to reduce elevated total cholesterol, LDL-C, Apo B, and
triglyceride levels, and to increase HDL-C in patients with primary
hypercholesterolemia and mixed dyslipidemia. In patients with a
history of myocardial infarction and hypercholesterolemia, niacin
the active ingredient in Niaspan, is indicated to reduce the risk
of recurrent non-fatal myocardial infarction or coronary artery
disease and hypercholesterolemia. Niacin, in combination with a
bile acid binding resin, is indicated to slow progression or
promote regression of atherosclerotic disease. Niaspan is
contraindicated in patients with allergies to any of its
ingredients, active peptic ulcer disease, significant or
unexplained persistent liver dysfunction, or arterial bleeding.
Niaspan should not be substituted for equivalent doses of
immediate-release niacin. Niaspan should be prescribed with caution
in patients who consume substantial amounts of alcohol and/or have
a past history of liver disease. Liver function tests should be
performed on all patients during therapy with Niaspan. Use of
Niaspan with other lipid-altering medications called statins may
increase the risk of rhabdomyolysis, a rare condition that causes
muscles to breakdown. The most common side effect with Niaspan is
flushing of the skin. Other commonly reported side effects include
indigestion, headache, pain, abdominal pain, nausea, itching,
diarrhea, running nose, vomiting and rash. Patients with diabetes
should carefully monitor their blood sugar and report changes to
their doctor. About Kos Pharmaceuticals, Inc. Kos Pharmaceuticals,
Inc. is a fully integrated specialty pharmaceutical company engaged
in developing, commercializing, manufacturing and marketing
proprietary prescription products for the treatment of chronic
diseases with a particular focus on the cardiovascular, metabolic
and respiratory disease areas. The Company's principal product
development strategy is to reformulate existing pharmaceutical
products with large market potential to improve safety, efficacy,
and patient compliance. Kos' strategy also includes making measured
investments in new chemical entity research through in-house and
sponsored research, scientific in-licensing and general corporate
development activities. The Company currently markets Niaspan and
Advicor(R), Azmacort(R), Cardizem(R)LA, and Teveten(R) and
Teveten(R)HCT. Kos has a strong and growing research and
development pipeline including proprietary drug delivery
technologies in solid-dose, inhalation and aerosol metered-dose
device administration to help fuel sustained, organic sales growth
into the future. Certain statements in this press release,
including statements relating to Niaspan CF (including optimized
Niaspan CF), the timing of the launch of the new range of Niaspan
CF products (including optimized Niaspan CF), the Company's strong
and growing research and development pipeline and future sales
growth are forward-looking and are subject to risks and
uncertainties which may cause actual results to differ materially
from those projected in a forward-looking statement. These risks
and uncertainties include market acceptance of Niaspan CF
(including optimized Niaspan CF), the protection afforded by the
Company's patents and those related to its acquired and licensed
products, the ability to build awareness for the Company's
products, including Niaspan CF and optimized Niaspan CF, within the
medical community, the continuing growth of the cardiovascular,
respiratory and allergy markets, the Company's ability to increase
the size of its sales force and to attract and retain sales
professionals, the Company's and its licensors' ability to achieve
regulatory approvals for products under development and to
successfully launch such products in a timely manner, the ability
of third party suppliers to the Company continuing to be able to
perform their supply obligations, the Company's ability to entered
into additional new business development opportunities, the
progress of the Company's research and development pipeline, the
effect of conditions in the pharmaceutical industry and the economy
in general, as well as certain other risks. A more detailed
discussion of risks attendant to the forward-looking statements
included in this press release are set forth in the
"Forward-Looking Information: Certain Cautionary Statements"
section of the Company's Annual Report on Form 10-K for the year
ended December 31, 2005, filed with the Securities and Exchange
Commission, and in other reports filed with the SEC. All
information in this press release is as of July 25, 2006 and the
Company undertakes no duty to update this information.
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