WOODCLIFF LAKE, N.J. and
SAN DIEGO, Oct. 28, 2014 /PRNewswire/ -- Eisai Inc. and
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced top-line
results of a pilot study to assess the safety of lorcaserin HCl, a
serotonin 2C receptor agonist, when coadministered with phentermine
HCl. The results of the investigational study demonstrate that the
short-term combination of lorcaserin plus phentermine does not
appear to be associated with an exacerbation in the proportion of
pre-specified adverse events compared to therapy with lorcaserin
alone.
The coadministration of lorcaserin and phentermine for weight
management is investigational. The efficacy and safety of
coadministration of lorcaserin and other weight loss products such
as phentermine have not been established.
The randomized, double-blind pilot study of 12-weeks duration in
overweight and obese adults evaluated whether short-term treatment
with lorcaserin 10 mg twice daily (BID) plus two doses of
immediate-release phentermine, 15 mg once daily (QD) or 15 mg BID,
is associated with exacerbation of potential serotonergic adverse
events compared to lorcaserin alone. In the trial, 238 subjects
were randomized to one of the three treatment arms in a 1:1:1 ratio
and received standardized weight-loss counseling during the
trial.
"The results of this investigational study provide us with
additional safety data that enhance the body of knowledge we have
for lorcaserin," said Gary Palmer,
MD, Eisai's Chief Medical Officer. "We look forward to sharing the
detailed results with the medical community at The Obesity
Society's Annual Scientific Meeting during ObesityWeek taking place
November 2-7 in Boston."
The primary endpoint of the trial assessed the proportion of
subjects reporting at least one of nine common potential
serotonergic adverse events (headache, dizziness, nausea, fatigue,
dry mouth, diarrhea, vomiting, insomnia, and/or anxiety) from
baseline to the end of treatment. As a safety study, the arms were
compared based on descriptive statistics.
The most common adverse events in the study overall were dry
mouth, headache, constipation, fatigue and dizziness.
About BELVIQ® (lorcaserin HCl) CIV
Lorcaserin is marketed in the United
States under the brand name BELVIQ. The prescribing
information for BELVIQ contains a limitation of use for
coadministration of lorcaserin and phentermine. BELVIQ is a
serotonin 2C receptor agonist approved as an adjunct to a
reduced-calorie diet and increased physical activity for chronic
weight management in adults who have a body mass index (BMI) of 30
kg/m2 or greater (obese), or BMI of 27 kg/m2
or greater (overweight) with at least one weight-related medical
condition such as high blood pressure, high cholesterol, or type 2
diabetes. It is not known if BELVIQ is safe and effective when
taken with other prescription, over-the-counter, or herbal weight
loss products, nor is it known if BELVIQ changes the risk of heart
problems or stroke, or death due to heart problems or stroke.
BELVIQ is believed to decrease food consumption and promote
satiety by selectively activating serotonin 2C receptors in the
brain. The exact mechanism of action of BELVIQ is not known.
IMPORTANT SAFETY INFORMATION
Contraindication
- BELVIQ should not be taken during pregnancy or by women who are
planning to become pregnant.
Warnings and Precautions
- BELVIQ is a serotonergic drug. The development of potentially
life-threatening serotonin syndrome or Neuroleptic Malignant
Syndrome (NMS)-like reactions have been reported during use of
serotonergic drugs, including, but not limited to, selective
serotonin-norepinephrine reuptake inhibitors, and selective
serotonin reuptake inhibitors, tricyclic antidepressants,
bupropion, triptans, dietary supplements such as St. John's Wort
and tryptophan, drugs that impair metabolism of serotonin
(including monoamine oxidase inhibitors), dextromethorphan,
lithium, tramadol, antipsychotics or other dopamine antagonists,
particularly when used in combination. Patients should be monitored
for the emergence of serotonin syndrome symptoms or NMS-like
reactions, including agitation, hallucinations, coma, tachycardia,
labile blood pressure, hyperthermia, hyperreflexia, incoordination,
nausea, vomiting, diarrhea, and muscle rigidity. Treatment with
BELVIQ and any concomitant serotonergic or antidopaminergic agents
should be discontinued immediately if the above events occur, and
supportive symptomatic treatment should be initiated.
- Patients should not take BELVIQ in combination with drugs that
have been associated with valvular heart disease (e.g.,
cabergoline). In clinical trials, 2.4% of patients taking BELVIQ
and 2.0% of patients taking placebo developed valvular
regurgitation: none of these patients was symptomatic. BELVIQ
should be used with caution in patients with congestive heart
failure (CHF). Patients who develop signs and symptoms of valvular
heart disease, including dyspnea, dependent edema, CHF, or a new
cardiac murmur, should be evaluated and discontinuation of BELVIQ
should be considered.
- Impairment in attention, memory, somnolence, confusion, and
fatigue, have been reported in patients taking BELVIQ. Patients
should not drive a car or operate heavy machinery until they know
how BELVIQ affects them.
- The recommended dose of 10 mg twice daily should not be
exceeded, as higher doses may cause euphoria, hallucination, and
dissociation. Monitor patients for the development or worsening of
depression, suicidal thoughts or behaviors, and/or any changes in
mood. Discontinue BELVIQ in patients who develop suicidal thoughts
or behaviors.
- Weight loss may increase the risk of hypoglycemia in patients
with type 2 diabetes mellitus who are being treated with
antidiabetic medications, so measurement of blood sugar levels
before and during treatment with BELVIQ is recommended. Decreases
in doses of antidiabetic medications or changes in medication
regimen should be considered.
- Men who experience priapism should immediately discontinue
BELVIQ and seek emergency medical attention. BELVIQ should be used
with caution with erectile dysfunction medications. BELVIQ should
be used with caution in men who have conditions that might
predispose them to priapism (e.g., sickle cell anemia, multiple
myeloma, or leukemia), or in men with anatomical deformation of the
penis (e.g., angulation, cavernosal fibrosis, or Peyronie's
disease).
- Because BELVIQ may cause a slow heartbeat, it should be used
with caution in patients with a history of bradycardia or heart
block greater than first degree.
- Consider monitoring for CBC changes, prolactin excess, and
pulmonary hypertension.
Most Common Adverse Reactions
- In patients without diabetes: headache (17%), dizziness (9%),
fatigue (7%), nausea (8%), dry mouth (5%), and constipation
(6%).
- In patients with diabetes: hypoglycemia (29%), headache (15%),
back pain (12%), cough (8%), and fatigue (7%).
Nursing Mothers
- BELVIQ should not be taken by women who are nursing.
BELVIQ is a federally controlled substance (CIV) because it may
be abused or lead to drug dependence.
For more information about BELVIQ, click here for the full US
FDA-approved Product Information or visit www.BELVIQ.com.
Eisai is responsible for the marketing and distribution of
BELVIQ in most territories worldwide under its agreement with
Arena. BELVIQ® is a registered trademark of Arena
Pharmaceuticals GmbH.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking
to bring innovative medicines targeting G protein-coupled receptors
to patients. Arena's internally discovered drug, BELVIQ®
(lorcaserin HCl), is approved in the
United States, and Arena is focused on discovering,
developing and commercializing additional drugs to address unmet
medical needs. Arena's US operations are located in San Diego, California, and its operations
outside of the United States,
including its commercial manufacturing facility, are located in
Zofingen, Switzerland. For more
information, visit Arena's website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc.
About Eisai Inc.
At Eisai Inc., human health care is our goal. Eisai gives its
first thoughts to patients and their families, and helping to
increase the benefits health care provides. As the US
pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., Eisai has a
passionate commitment to patient care that is the driving force
behind Eisai's efforts to help address unmet medical needs. Eisai
is a fully integrated pharmaceutical business with discovery,
clinical, manufacturing and marketing capabilities. Our key areas
of commercial focus include oncology and specialty care
(Alzheimer's disease, epilepsy and metabolic disorders). To learn
more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey, North
Carolina and Pennsylvania,
as well as a global demand chain organization that includes
manufacturing facilities in Maryland and North
Carolina. Eisai's global areas of R&D focus include
neuroscience; oncology; metabolic disorders; vascular, inflammatory
and immunological reaction; and antibody-based programs.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such
forward-looking statements include statements about the
advancement, therapeutic indication, use, safety, efficacy,
mechanism of action, and potential of BELVIQ or lorcaserin,
including with respect to coadministration with phentermine;
significance of the top-line results of the pilot study assessing
the safety of lorcaserin when coadministered with phentermine,
including providing additional safety data that enhances the body
of knowledge for lorcaserin; future presentation of the trial
results; rights, obligations and activities under the marketing and
supply agreement among Arena and Eisai; embracing the challenge of
improving health; seeking to bring innovative medicines to
patients; and Arena's focus, plans, goals, strategy, expectations,
research and development programs, and ability to discover and
develop compounds and commercialize drugs. For such statements,
Arena claims the protection of the Private Securities Litigation
Reform Act of 1995. Actual events or results may differ materially
from Arena's expectations. Factors that could cause actual results
to differ materially from the forward-looking statements include,
but are not limited to, the following: top-line results are not
comprehensive and are based on a preliminary analysis of then
available data, and findings and conclusions related to the trial
are subject to change following a more comprehensive review of the
data; risks related to commercializing drugs, including regulatory,
manufacturing, supply and marketing issues and the availability and
use of BELVIQ; cash and revenues generated from BELVIQ, including
the impact of competition; Arena's revenues will be based in part
on estimates, judgment and accounting policies, and incorrect
estimates or disagreement regarding estimates or accounting
policies may result in changes to Arena's guidance or previously
reported results; the timing and outcome of regulatory review is
uncertain, and BELVIQ may not be approved for marketing when
expected or ever in combination with another drug, for another
indication or using a different formulation or in any other
territory for any indication; regulatory decisions in one territory
may impact other regulatory decisions and Arena's business
prospects; government and commercial reimbursement and pricing
decisions; risks related to relying on collaborative arrangements;
the timing and receipt of payments and fees, if any, from
collaborators; the entry into or modification or termination of
collaborative arrangements; unexpected or unfavorable new data;
nonclinical and clinical data is voluminous and detailed, and
regulatory agencies may interpret or weigh the importance of data
differently and reach different conclusions than Arena or others,
request additional information, have additional recommendations or
change their guidance or requirements before or after approval;
data and other information related to any of Arena's research and
development may not meet regulatory requirements or otherwise be
sufficient for (or Arena or a collaborator may not pursue) further
research and development, regulatory review or approval or
continued marketing; Arena's ability to obtain and defend patents;
the timing, success and cost of Arena's research and development;
results of clinical trials and other studies are subject to
different interpretations and may not be predictive of future
results; clinical trials and other studies may not proceed at the
time or in the manner expected or at all; having adequate funds;
and satisfactory resolution of litigation or other disagreements
with others. Additional factors that could cause actual results to
differ materially from those stated or implied by Arena's
forward-looking statements are disclosed in Arena's filings with
the Securities and Exchange Commission. These forward-looking
statements represent Arena's judgment as of the time of this
release. Arena disclaims any intent or obligation to update these
forward-looking statements, other than as may be required under
applicable law.
Contacts: Eisai
Inc.
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Investor
Inquiries:
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Media
Inquiries:
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Alex
Scott
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Laurie
Landau
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alex_scott@eisai.com
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Laurie_Landau@eisai.com
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201.746.2177
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201.746.2510
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Contact: Arena
Pharmaceuticals, Inc.
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Craig M. Audet,
Ph.D., Senior Vice President,
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David Schull,
President
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Operations & Head
of Global Regulatory Affairs
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Russo
Partners
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caudet@arenapharm.com
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david.schull@russopartnersllc.com
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858.453.7200, ext.
1612
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858.717.2310
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www.eisai.com/US
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www.arenapharm.com
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SOURCE Arena Pharmaceuticals, Inc.; Eisai Inc.