Well Tolerated; Potential for Efficacy at Higher Doses in Next Trial
Poster Presentation at the NCDEU Annual Meeting Explores Second Indication in Alcohol Abuse Disorder
CAMBRIDGE, MA, USA I May 29, 2013 I Euthymics Bioscience, Inc. today announced top-line results from TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects), a phase 2b/3a clinical study designed to assess the safety and efficacy of amitifadine in patients with major depressive disorder (MDD) failing to respond to one course of first-line antidepressants. Amitifadine is a novel serotonin-preferring triple reuptake inhibitor antidepressant. In TRIADE, amitifadine efficacy at 50 or 100 mg doses did not show a statistically significant difference from placebo in the primary endpoint of a change in MADRS (Montgomery–Åsberg Depression Rating Scale). However, an active comparator arm shows the study itself did work, and the dose range for amitifadine may have been too low. Further, the lack of side effects with the 100 mg dose, combined with signs of efficacy in several post-hoc analyses, suggests that higher doses may show benefit in the target MDD patient group.
At both doses, amitifadine was well tolerated, without the side effects associated with the most common pharmacological treatments for depression. Amitifadine demonstrated no weight gain, no increases in blood pressure or heart rate and no loss of sexual function in contrast to paroxetine, which caused significant sexual dysfunction.
“Amitifadine continues to have the potential to fulfill a critical unmet need among depression patients as one of the few monotherapy antidepressants for non-responders that has both a favorable sexual function and weight profile,” said Anthony A. McKinney, President and CEO of Euthymics. “We are actively exploring the best options for a new clinical study with higher doses of amitifadine in this population.”
TRIADE principal investigator Maurizio Fava, MD, Executive Director of the Clinical Trials Network and Institute at Massachusetts General Hospital, said, “The findings suggest that amitifadine was under-dosed, given the robust efficacy of the comparator paroxetine in the same study. However, the good tolerability of amitifadine allows for a significant dose escalation in the next study, aimed at replicating the positive findings of a previously conducted proof-of-concept study in patients with a new-onset major depressive episode.”
Euthymics is also investigating the possible use of amitifadine in a second indication, as a treatment for Alcohol Abuse Disorder. A poster is being presented by Randall Marshall, MD, Euthymics Vice President of Clinical Development, at the NCDEU annual meeting. This is the first presentation examining amitifadine’s potential in this indication.
Amitifadine is a single molecule that acts on three neurotransmitters—serotonin, norepinephrine and dopamine—in a potency ratio of 1 to 2 to 8. This ratio is optimized to increase antidepressant efficacy while reducing the adverse effects that can limit compliance with antidepressants, including weight gain and loss of sexual function. TRIADE evaluated amitifadine for patients with MDD who did not respond adequately to one and only one course of first-line antidepressants including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), bupropion or tricyclic antidepressants. These represent some of the most commonly used medications in the $11 billion US antidepressant market.
About Euthymics Bioscience
Euthymics Bioscience, Inc. is a neuroscience-focused clinical-stage company developing next-generation treatments for central nervous system disorders. Amitifadine is a triple reuptake inhibitor that acts on serotonin, norepinephrine and dopamine in a specific ratio and is given as monotherapy. Amitifadine has demonstrated proof-of-concept efficacy as treatment for major depression without causing weight gain or loss of sexual function, which often lead to poor adherence to standard antidepressants.
Euthymics is a private corporation with headquarters in Cambridge, Massachusetts. Additional information can be found on the company’s website at www.euthymics.com.
SOURCE: Euthymics
Post Views: 135
Well Tolerated; Potential for Efficacy at Higher Doses in Next Trial
Poster Presentation at the NCDEU Annual Meeting Explores Second Indication in Alcohol Abuse Disorder
CAMBRIDGE, MA, USA I May 29, 2013 I Euthymics Bioscience, Inc. today announced top-line results from TRIADE (Triple Reuptake Inhibitor Anti-Depressant Effects), a phase 2b/3a clinical study designed to assess the safety and efficacy of amitifadine in patients with major depressive disorder (MDD) failing to respond to one course of first-line antidepressants. Amitifadine is a novel serotonin-preferring triple reuptake inhibitor antidepressant. In TRIADE, amitifadine efficacy at 50 or 100 mg doses did not show a statistically significant difference from placebo in the primary endpoint of a change in MADRS (Montgomery–Åsberg Depression Rating Scale). However, an active comparator arm shows the study itself did work, and the dose range for amitifadine may have been too low. Further, the lack of side effects with the 100 mg dose, combined with signs of efficacy in several post-hoc analyses, suggests that higher doses may show benefit in the target MDD patient group.
At both doses, amitifadine was well tolerated, without the side effects associated with the most common pharmacological treatments for depression. Amitifadine demonstrated no weight gain, no increases in blood pressure or heart rate and no loss of sexual function in contrast to paroxetine, which caused significant sexual dysfunction.
“Amitifadine continues to have the potential to fulfill a critical unmet need among depression patients as one of the few monotherapy antidepressants for non-responders that has both a favorable sexual function and weight profile,” said Anthony A. McKinney, President and CEO of Euthymics. “We are actively exploring the best options for a new clinical study with higher doses of amitifadine in this population.”
TRIADE principal investigator Maurizio Fava, MD, Executive Director of the Clinical Trials Network and Institute at Massachusetts General Hospital, said, “The findings suggest that amitifadine was under-dosed, given the robust efficacy of the comparator paroxetine in the same study. However, the good tolerability of amitifadine allows for a significant dose escalation in the next study, aimed at replicating the positive findings of a previously conducted proof-of-concept study in patients with a new-onset major depressive episode.”
Euthymics is also investigating the possible use of amitifadine in a second indication, as a treatment for Alcohol Abuse Disorder. A poster is being presented by Randall Marshall, MD, Euthymics Vice President of Clinical Development, at the NCDEU annual meeting. This is the first presentation examining amitifadine’s potential in this indication.
Amitifadine is a single molecule that acts on three neurotransmitters—serotonin, norepinephrine and dopamine—in a potency ratio of 1 to 2 to 8. This ratio is optimized to increase antidepressant efficacy while reducing the adverse effects that can limit compliance with antidepressants, including weight gain and loss of sexual function. TRIADE evaluated amitifadine for patients with MDD who did not respond adequately to one and only one course of first-line antidepressants including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), bupropion or tricyclic antidepressants. These represent some of the most commonly used medications in the $11 billion US antidepressant market.
About Euthymics Bioscience
Euthymics Bioscience, Inc. is a neuroscience-focused clinical-stage company developing next-generation treatments for central nervous system disorders. Amitifadine is a triple reuptake inhibitor that acts on serotonin, norepinephrine and dopamine in a specific ratio and is given as monotherapy. Amitifadine has demonstrated proof-of-concept efficacy as treatment for major depression without causing weight gain or loss of sexual function, which often lead to poor adherence to standard antidepressants.
Euthymics is a private corporation with headquarters in Cambridge, Massachusetts. Additional information can be found on the company’s website at www.euthymics.com.
SOURCE: Euthymics
Post Views: 135
