— Phase 3b Study Designed to Further Evaluate ALKS 5461’s Potential Benefits on Mood Domains Regulated by Endogenous Opioid Modulation —
— Company Reiterates Plans to Submit New Drug Application to FDA by Year-End 2017 —
DUBLIN, Ireland I June 12, 2017 I Alkermes plc (NASDAQ: ALKS) today announced the initiation of study 217, a phase 3b trial of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). The study will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs for depression, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). In addition to the traditional Montgomery–Åsberg Depression Rating Scale (MADRS) for assessing improvement in depression symptoms, study 217 will include scales to further evaluate ALKS 5461’s potential benefits on mood and associated behavioral domains known to be regulated by endogenous opioid modulation. The company also reiterated plans to submit a New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of MDD to the U.S. Food and Drug Administration (FDA) by year-end 2017.
“Opioid modulation represents a new mechanism for the treatment of depression that may provide benefits beyond those observed with traditional antidepressants. Along with the clinical community, we are looking forward to further exploring ALKS 5461’s potential in regulating domains such as social connection, resilience and anhedonia. Study 217 includes scales and endpoints to help elucidate ALKS 5461’s potential effects on these specific mood domains where opioid modulation may yield singular benefit,” stated Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “In parallel, we plan to meet with the FDA in July for our scheduled pre-NDA meeting and are preparing our New Drug Application for ALKS 5461 for the adjunctive treatment of MDD.”
Study 217 is a phase 3b, multinational, randomized, double-blind, placebo-controlled clinical trial that will evaluate the efficacy, safety and tolerability of ALKS 5461 as adjunctive treatment in patients with MDD. The 11-week, 2-stage study will randomize up to 325 patients and incorporates design features informed by the FORWARD pivotal program to help ensure rigorous patient selection, monitoring and evaluation. The primary objective of the study is to assess ALKS 5461’s ability to improve depressive symptoms, as measured by MADRS-6 and MADRS-10. Specific scales to evaluate additional potential benefits of ALKS 5461 included in study 217 are the Connor-Davidson Resilience Scale (CD-RISC), Snaith-Hamilton Pleasure Scale (SHAPS), Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Brief Pain Inventory-Short Form (BPI-SF), and the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.
About ALKS 5461
ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as a balanced neuromodulator in the brain and represents a novel mechanism of action for the adjunctive treatment of MDD. ALKS 5461 consists of samidorphan and buprenorphine, and is designed to rebalance brain function that is dysregulated in the state of depression. In October 2013, the FDA granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.
About MDD
According to the DSM-5® (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 17 million people in the U.S. suffer from MDD in a given year,1,2 the majority of whom may not adequately respond to initial antidepressant therapy.3
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
DSM-5® is a registered trademark of the American Psychiatric Association.
1 Kessler RC et al (2005) Archives of General Psychiatry, Jun; 62 (6), pp. 617-27.
2 U.S. Census.
3 Rush AJ et al (2007) Am J. Psychiatry, 163:11, pp. 1905-1917 (STAR*D Study).
SOURCE: Alkermes
Post Views: 25
— Phase 3b Study Designed to Further Evaluate ALKS 5461’s Potential Benefits on Mood Domains Regulated by Endogenous Opioid Modulation —
— Company Reiterates Plans to Submit New Drug Application to FDA by Year-End 2017 —
DUBLIN, Ireland I June 12, 2017 I Alkermes plc (NASDAQ: ALKS) today announced the initiation of study 217, a phase 3b trial of ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD). The study will evaluate the efficacy and safety of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs for depression, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). In addition to the traditional Montgomery–Åsberg Depression Rating Scale (MADRS) for assessing improvement in depression symptoms, study 217 will include scales to further evaluate ALKS 5461’s potential benefits on mood and associated behavioral domains known to be regulated by endogenous opioid modulation. The company also reiterated plans to submit a New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of MDD to the U.S. Food and Drug Administration (FDA) by year-end 2017.
“Opioid modulation represents a new mechanism for the treatment of depression that may provide benefits beyond those observed with traditional antidepressants. Along with the clinical community, we are looking forward to further exploring ALKS 5461’s potential in regulating domains such as social connection, resilience and anhedonia. Study 217 includes scales and endpoints to help elucidate ALKS 5461’s potential effects on these specific mood domains where opioid modulation may yield singular benefit,” stated Elliot Ehrich, M.D., Executive Vice President, Research and Development of Alkermes. “In parallel, we plan to meet with the FDA in July for our scheduled pre-NDA meeting and are preparing our New Drug Application for ALKS 5461 for the adjunctive treatment of MDD.”
Study 217 is a phase 3b, multinational, randomized, double-blind, placebo-controlled clinical trial that will evaluate the efficacy, safety and tolerability of ALKS 5461 as adjunctive treatment in patients with MDD. The 11-week, 2-stage study will randomize up to 325 patients and incorporates design features informed by the FORWARD pivotal program to help ensure rigorous patient selection, monitoring and evaluation. The primary objective of the study is to assess ALKS 5461’s ability to improve depressive symptoms, as measured by MADRS-6 and MADRS-10. Specific scales to evaluate additional potential benefits of ALKS 5461 included in study 217 are the Connor-Davidson Resilience Scale (CD-RISC), Snaith-Hamilton Pleasure Scale (SHAPS), Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, Brief Pain Inventory-Short Form (BPI-SF), and the Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.
About ALKS 5461
ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as a balanced neuromodulator in the brain and represents a novel mechanism of action for the adjunctive treatment of MDD. ALKS 5461 consists of samidorphan and buprenorphine, and is designed to rebalance brain function that is dysregulated in the state of depression. In October 2013, the FDA granted Fast Track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies.
About MDD
According to the DSM-5® (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 17 million people in the U.S. suffer from MDD in a given year,1,2 the majority of whom may not adequately respond to initial antidepressant therapy.3
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
DSM-5® is a registered trademark of the American Psychiatric Association.
1 Kessler RC et al (2005) Archives of General Psychiatry, Jun; 62 (6), pp. 617-27.
2 U.S. Census.
3 Rush AJ et al (2007) Am J. Psychiatry, 163:11, pp. 1905-1917 (STAR*D Study).
SOURCE: Alkermes
Post Views: 25
