Doctor Online Consultation
is a medical plan provider that allows members to have real-time webcam & telephone consultation with our doctors anytime, anywhere. Doctor Online Consultation's medical consultation services are done real-time via webcam or telephone through our advanced medical portal and telephony technology to connect our members to our doctors instantly.
Sunday, December 6, 2015
Sunovion Announces Results of Health Outcomes Analyses Exploring the Effectiveness of Aptiom® (eslicarbazepine acetate) in People with Partial-Onset Seizures
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion
Pharmaceuticals Inc. About Lamprene (Clofazimine) with free prescription (Sunovion) announced results of Health
Economics and Outcomes Research (HEOR) analyses from two Phase 3 Aptiom®
(eslicarbazepine acetate) monotherapy clinical trials; and a claims
analysis of a large database of patients with epilepsy. Buy Minocin (Minocycline) without Rx The results were
presented during the 69th American Epilepsy Society (AES)
Annual Meeting in Philadelphia.
In August 2015, Sunovion announced
that the U.S. Diabecon () with free Rx Food and Drug Administration (FDA) approved the use of
APTIOM as monotherapy for the treatment of partial-onset seizures. Iobet without prescription
APTIOM may be used as monotherapy in people who initiate treatment for
the first time or convert from other antiepileptic drugs (AEDs) to
APTIOM.
A post-hoc pooled analysis of two historical-controlled Phase 3 APTIOM
monotherapy clinical trials (Studies 093-045 and 093-046) showed that
patients with partial-onset seizures who achieved a clinical response
after converting from a multi-AED regimen to APTIOM monotherapy
experienced quality of life improvements after 10 weeks. Buy Calan Sr (Verapamil) with free prescription A separate
analysis of these studies also showed that patients with partial-onset
seizures experienced statistically and clinically significant
improvements in depressive symptoms after 10 weeks, following successful
conversion from their current AED regimen to APTIOM monotherapy.
During AES, Sunovion also presented an analysis from the IMS PharMetrics
Plus database. Buy Hypoallergenic Vitamin C online The results indicated that, after controlling for
baseline confounders, patients initiating AED therapy with one pill/day
had fewer annual hospitalizations and emergency room visits than
initiating AED therapy with two or more pills/day.
“Seizures account for one million emergency department visits every
year, and epilepsy has significant impacts on a person’s ability to
drive or maintain employment,” said Krithika Rajagopalan, Head of Global
Health Economics and Outcomes Research, Sunovion. http://medicalquestionanswers.wordpress.com “Quality of life
assessments provide insights into measurable factors that are important
in determining potential treatment outcomes. These results suggest
improved seizure control with AED monotherapy is correlated with overall
improvements in specific aspects of daily life, as well as fewer
hospitalizations. Sunovion is committed to providing health outcomes
data that may contribute to improved treatment approaches for people
living with partial-onset seizures.”
Summary of Highlighted HEOR Poster Presentations
Quality of Life Improvement among Patients with Refractory
Partial-Onset Seizures: A Clinical Trial Analysis of Patients who
Responded to Eslicarbazepine Acetate Monotherapy (Poster 1.182,
Presented Saturday, December 5, 2015, 12:00 p.m. – 6:00 p.m. ET)
Pooled data from two historical-controlled Phase 3 studies (093-045 and
093-046) evaluated patients who had completed 10 weeks of APTIOM
monotherapy (n=224) for change in health-related quality of life, using
Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire. The QOLIE-31 is
an instrument that assesses daily functioning and overall well-being in
patients with epilepsy. The mean change in QOLIE-31 Total Score and
seven subscale scores from baseline to Week 18 were compared to standard
minimal clinically-important difference (MCID) change scores. The
results showed that the mean change in QOLIE-31 Total Score and five of
the seven subscales (Medication Effects, Seizure Worry, Social
Functioning, Overall Quality of Life, Cognitive Functioning, and
Energy/Fatigue) were greater than their respective MCIDs; these changes
were statistically significant for Medication Effects (p=0.011), and
Social Functioning (p=0.008).
Change in Depressive Symptoms Among Patients With Refractory
Partial-Onset Seizures Treated With Eslicarbazepine Acetate Monotherapy:
A Pooled Analysis of Clinical Trials (Poster 2.249, Presented Sunday,
December 6, 8:00 a.m. – 4:00 p.m. ET)
Pooled data from two historical-controlled Phase 3 studies (093-045 and
093-046) evaluated patients who had completed 10 weeks of APTIOM
monotherapy (Completers, n=224), as well as a subset of these patients
who achieved a clinical response after 10 weeks of treatment
(Responders, n=117), for change in depressive symptoms, using the
Montgomery-Asberg Depression Rating Scale (MADRS) questionnaire. The
MADRS is a 10-item instrument used to identify moderate-to-severe
depressive symptoms. MADRS scores were compared to 1) Population-level
MCID change scores (range: 1.3 to 1.6); and 2) Treatment effect MCID
change scores (1 point versus active treatment or 2 points versus
placebo).
Data showed that mean change in the MADRS scores was significantly
decreased (indicating a reduction in depressive symptoms) and exceeded
published MCID change scores (-2.1 for Completers and -2.6 for
Responders, p<0.001 for both). Over half of all patients in these groups
(56.3 percent of Completers and 56.4 percent of Responders) experienced
significant reductions in depressive symptoms—with most patients (90.5
percent and 87.9 percent, respectively) reporting decreased MADRS scores
of two or more points.
The Association Between Antiepileptic Drug Pill Burden at
Monotherapy Initiation and Epilepsy-Related Hospital Admissions and
Emergency Department Visits in the US (Poster 2.282, Presented Sunday,
December 6, 8:00 a.m. – 4:00 p.m. ET)
A retrospective analysis of health insurance claims data from more than
53,000 epilepsy patients who initiated AED monotherapy found that
patients who initiated with a one pill/day regimen had fewer
hospitalizations and emergency room visits over the following 12 months
compared with patients initiating with two or more AEDs. Patients
initiating with two, three, or more than three pill/day regimens had
annual hospitalization rates that were 12.5, 23.1, and 19.4 percent
higher respectively, compared to patients taking one pill/day. Patients
initiating with larger pill burdens also had significantly higher rates
of emergency room visits during the year of following-up (15.5 , 25.2,
and 15.1 percent higher for patients taking two, three, or more than
three pills/day, respectively).
About the Phase 3 Monotherapy Studies
Two identically designed Phase 3, dose-blinded, historical-controlled,
multi-center, randomized clinical trials (Studies 093-045 and 093-046)
evaluated the safety and efficacy of APTIOM (1,600 mg/day or 1,200
mg/day) as monotherapy for partial-onset seizures in patients 16 years
of age or older whose seizures were not well-controlled with other
antiepileptic drugs (AEDs).
The primary endpoint for both trials was the percentage of patients who
exited the study due to pre-defined criteria identifying worsening
seizure control, compared to historical controls from previous,
similarly designed trials of epilepsy patients converting to AED
monotherapy. Trial results showed that conversion to APTIOM monotherapy
was associated with exit rates superior to historical controls in
patients with partial-onset seizures, who were not well-controlled by
one or two current AEDs.
APTIOM administered once-daily was generally well tolerated in both dose
strengths. In the APTIOM monotherapy trials, the most common
treatment-related adverse events, headache, dizziness, fatigue,
somnolence, and nausea, were mainly mild or moderate in severity.
About Aptiom® (eslicarbazepine acetate)
APTIOM is the latest member of the dibenzazepine carboxamide family of
antiepileptic drugs (AEDs), an established class of medicines. APTIOM is
the only exclusively once-daily, non-extended release AED now
FDA-approved for use as monotherapy or adjunctive therapy for
partial-onset seizures. The precise mechanism(s) by which
eslicarbazepine, the primary active metabolite of APTIOM, exerts
anticonvulsant activity is unknown but is thought to involve inhibition
of voltage-gated sodium channels. APTIOM can be taken whole or crushed,
with or without food. APTIOM is not classified as a controlled substance
by the FDA.
The initial research and development of eslicarbazepine acetate was
performed by BIAL-Portela & Ca, S.A. (BIAL), a privately held Portuguese
research-based pharmaceutical company. Subsequently, Sunovion acquired
the rights under an exclusive license to further develop and
commercialize eslicarbazepine acetate in the United States and Canada
markets from BIAL. BIAL gained approval for eslicarbazepine acetate from
the European Medicines Agency on April 21, 2009 as adjunctive therapy in
adult patients with partial-onset seizures with or without secondary
generalization. In Europe, the product is marketed under the trade name
Zebinix®. APTIOM is approved in Canada for use as adjunctive
therapy in the treatment of partial-onset seizures in patients with
epilepsy who are not satisfactorily controlled with conventional therapy.
About Epilepsy and Partial-Onset Seizures
Epilepsy is the fourth most common neurological condition, and one in 26
people in the U.S. will develop epilepsy in his or her lifetime.i
Epilepsy manifests as unprovoked seizures, which are caused by abnormal
firing of impulses from nerve cells in the brain.ii
Partial-onset seizures, the most common type of seizure, are
characterized by bursts of electrical activity that are initially
focused in specific areas of the brain and may become more widespread,
with symptoms varying according to the affected areas.iii The
unpredictable nature of seizures may have a significant impact on those
with epilepsy. Reducing the frequency of seizures may lessen the burden
of epilepsy.ii With approximately one-third of people living
with epilepsy still unable to control seizures, there continues to be a
need for new therapies.iv Up to 40 percent of people living
with epilepsy do not respond to the first or second monotherapyv,
and approximately 36 percent fail to achieve adequate control of
seizures despite the use of two or more antiepileptic medicationsvi.
Please see Important Safety Information below.
INDICATION:
Aptiom® (eslicarbazepine acetate) is a prescription medicine used alone
or with other medicines to treat partial-onset seizures.
IMPORTANT SAFETY INFORMATION:
Do not take APTIOM if you are allergic to eslicarbazepine acetate, any
of the other ingredients in APTIOM, or oxcarbazepine.
Suicidal behavior and ideation: APTIOM may cause suicidal
thoughts or actions, depression, or mood problems. Call your doctor
right away if you experience these or any other effects or reactions:
thoughts about suicide or dying; attempting to commit suicide; new or
worse depression, anxiety, or irritability; feeling agitated or
restless; panic attacks; trouble sleeping (insomnia); acting aggressive;
being angry or violent; acting on dangerous impulses; an extreme
increase in activity and talking (mania); or other unusual changes in
behavior or mood.
Allergic reactions: APTIOM may cause serious skin rash or other
serious allergic reactions that may affect organs or other parts of your
body like the liver or blood cells. You may or may not have a rash with
these types of reactions. Call your doctor right away if you experience
any of the following symptoms: swelling of the face, eyes, lips, or
tongue; trouble swallowing or breathing; hives; fever, swollen glands,
or sore throat that do not go away or come and go; painful sores in the
mouth or around your eyes; yellowing of the skin or eyes; unusual
bruising or bleeding; severe fatigue or weakness; severe muscle pain; or
frequent infections or infections that do not go away.
Low salt (sodium) levels in the blood: APTIOM may cause the level
of sodium in your blood to be low. Symptoms may include nausea,
tiredness, lack of energy, irritability, confusion, muscle weakness or
muscle spasms, or more frequent or more severe seizures. Some medicines
can also cause low sodium in your blood. Be sure to tell your healthcare
provider about all the other medicines that you are taking.
Nervous system problems: APTIOM may cause problems that can
affect your nervous system, including dizziness, sleepiness, vision
problems, trouble concentrating, and difficulties with coordination and
balance. APTIOM may slow your thinking or motor skills. Do not drive or
operate heavy machinery until you know how APTIOM affects you.
Liver problems: APTIOM may cause problems that can affect your
liver. Symptoms of liver problems include yellowing of your skin or the
whites of your eyes, nausea or vomiting, loss of appetite, stomach pain,
or dark urine.
Most common adverse reactions: The most common side effects in
patients taking APTIOM include dizziness, sleepiness, nausea, headache,
double vision, vomiting, feeling tired, problems with coordination,
blurred vision, and shakiness.
Drug interactions: Tell your healthcare provider about all the
medicines you take, including prescription and over-the counter
medicines, vitamins, and herbal supplements. Taking APTIOM with certain
other medicines may cause side effects or affect how well they work. Do
not start or stop other medicines without talking to your
healthcare provider. Especially tell your healthcare provider if you
take oxcarbazepine, carbamazepine, phenobarbital, phenytoin, primidone,
clobazam, omeprazole, simvastatin, rosuvastatin, or birth control
medicine.
Discontinuation: Do not stop taking APTIOM without first talking
to your healthcare provider. Stopping APTIOM suddenly can cause serious
problems.
Pregnancy and lactation: APTIOM may cause your birth control
medicine to be less effective. Talk to your healthcare provider about
the best birth control method to use. APTIOM may harm your unborn baby.
APTIOM passes into breast milk. Tell your healthcare provider if you are
pregnant or plan to become pregnant, or are breastfeeding or plan to
breastfeed. You and your healthcare provider will decide if you should
take APTIOM. If you become pregnant while taking APTIOM, talk to your
healthcare provider about registering with the North American
Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this
registry is to collect information about the safety of antiepileptic
medicine during pregnancy. You can enroll in this registry by calling
1-888-233-2334.
Get medical help right away if you have any of the symptoms listed
above.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit .fda.gov/medwatch
or call 1-800-FDA-1088.
For more information, please see the APTIOM
Medication Guide and Full
Prescribing Information.
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious medical
conditions. Sunovion’s spirit of innovation is driven by the conviction
that scientific excellence paired with meaningful advocacy and relevant
education can improve lives. The Company has charted new paths to
life-transforming treatments that reflect ongoing investments in
research and development and an unwavering commitment to support people
with psychiatric, neurological, and respiratory conditions. Sunovion’s
track record of discovery, development and commercialization of
important therapies has included Brovana® (arformoterol
tartrate), Latuda® (lurasidone HCI), and most recently Aptiom®
(eslicarbazepine acetate).
Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly
owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada, Inc., based in Mississauga, Ontario, are
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found on the Company’s web sites: .sunovion.com,
.sunovion.eu
and .sunovion.ca.
Connect with Sunovion on Twitter @Sunovion
and LinkedIn.
BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.
LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
APTIOM is under license from BIAL.
© 2015 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion’s web site at .sunovion.com
References
i Institute of Medicine (IOM). 2012. “Epilepsy across the
spectrum: Promoting health and understanding.” Washington, DC: The
National Academies Press.
ii National Institutes of Health. “NINDS Epilepsy Information
Page” Accessed July 2015. <.ninds.nih.gov/disorders/epilepsy/epilepsy.htm>
iii Epilepsy Foundation. “Complex Partial Seizures.” Accessed
July 2015. <.epilepsy.com/learn/types-seizures/complex-partial-seizures>.
iv Brodie MJ, Barry SJE, Bamagous GA, Norrie JD, Kwan P.
Patterns of treatment response in newly diagnosed epilepsy. Neurology.
2012;78:1548-1554.
v Kwan P, Brodie MJ. “Early Identification of Refractory
Epilepsy.” New England Journal of Medicine (2000): 342(5):314-9. .ncbi.nlm.nih.gov/pubmed/10660394.
vi Epilepsy Foundation. “Epilepsy Foundation Position
Statement” <.epilepsycolorado.org/index.php?s=12105>.
Accessed June 2015.
Subscribe to:
Posts (Atom)