Our Programs : MDD and Amitifadine

Amitifadine, A Next-Generation Antidepressant for Major Depressive Disorder

Amitifadine (formerly EB-1010) is a triple reuptake inhibitor with the greatest potency towards serotonin reuptake (5-HT), half as much towards norepinephrine reuptake (NE) and one eighth towards dopamine reuptake (DA). Thus, amitifadine has the greatest affect on synaptic 5-HT, half as much on NE and one eighth on DA. This 1 to 2 to 8 ratio approximates the pharmacology of the two product combination found to have favorable outcomes in STAR*D, a 4000 patient study conducted by the Federal government.

By overlaying norepinephrine and dopamine on the well-established role of serotonin it is believed that amitifadine has the potential to increase antidepressant efficacy while reducing the adverse effects that can limit compliance with medication including weight gain, sexual dysfunction and impaired cognition (Click here to learn about our technology)

As shown on the chart below, a treatment effect analysis showed amitifadine to have the greatest relative effect compared to other monotherapy (single pill) antidepressants. This favorable profile for amitifadine warrants further study.

Clinical Results

Phase 2 clinical data presented at the 2010 American College of Neuropsychopharmacology (ACNP) meeting showed that amitifadine is effective for treating major depressive disorder (MDD) based on multiple standard measures of outcome for depression. amitifadine also improved measures of anhedonia, a hallmark symptom of MDD, which is characterized by the inability to experience pleasure. The data further demonstrate that amitifadine is well tolerated, without the adverse effects associated with the most common pharmacological treatments for depression.

In all, nine human studies have shown amitifadine to have a favorable safety profile with no evidence of weight gain or loss of sexual function.

Phase 2b/3a clinical trial

TRIADE is a phase 2b/3a trial which compares amitifadine, paroxetine, and placebo using the Sequential Parallel Comparative Design (SPCD) in MDD patients failing one course of SSRI or SNRI.  The TRIADE principal investigator is Dr. Maurizio Fava, Executive Vice Chair of Psychiatry at Massachusetts General Hospital. The trial began in March 2011 and top-line results are expected in summer 2012. [http://www.clinicaltrials.gov/ct2/results?term=EB1010]

Do you know someone who might qualify for the TRIADE trial? Learn more about our depression clinical trial.

Major Depressive Disorder

Major depressive disorder, also called major depression or MDD, is characterized by a combination of symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once–pleasurable activities. Major depression is disabling and prevents a person from functioning normally. An episode of major depression may occur only once in a person’s lifetime, but more often, it recurs throughout a person’s life.

Antidepressants are believed to work to normalize naturally occurring brain chemicals called neurotransmitters, notably serotonin and norepinephrine. Other antidepressants work on the neurotransmitter dopamine. Scientists studying depression have found that these particular chemicals are involved in regulating mood, but they are unsure of the exact ways in which they work.

Some facts about MDD:

• Major depressive disorder is the leading cause of disability in the U.S. for ages 15-44 (The World Health Organization 2008)
• Major depressive disorder affects approximately 14.8 million American adults, or about 6.7 percent of the U.S. population age 18 and older in a given year. (Kessler 2005, U.S. Census Bureau)
• While major depressive disorder can develop at any age, the median age at onset is 32 (Kessler 2005)
• Major depressive disorder is more prevalent in women than in men (Kessler 2003)

For more information, please visit the National Institute of Mental Health website: http://www.nimh.nih.gov/statistics/1MDD_ADULT.shtml

Source: National Institute of Mental Health; Euthymics Bioscience