Sunovion Announces Results of Health Outcomes Analyses Exploring the Effectiveness of Aptiom® eslicarbazepine acetate in People with Partial-Onset…

Sunovion Announces Results of Health Outcomes Analyses Exploring the Effectiveness of Aptiom® eslicarbazepine acetate in People with Partial-Onset Seizures

By a News Reporter-Staff News Editor at Biotech Week -- Sunovion Pharmaceuticals Inc. (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. The results were presented during the 69th American Epilepsy Society (AES) Annual Meeting in Philadelphia (see also Sunovion Pharmaceuticals Inc.).

In August 2015, Sunovion announced that the U.S. Food and Drug Administration (FDA) approved the use of APTIOM as monotherapy for the treatment of partial-onset seizures. 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. 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. 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. "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.

Keywords for this news article include: Sunovion Pharmaceuticals Inc., Therapy, Epilepsy, Quality of Life, Clinical Trials and Studies, Central Nervous System Diseases.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2015, NewsRx LLC