Pipeline
: TNX-601 for Major Depressive Disorder (Depression)

TNX-601 for Major Depressive Disorder (Depression)

According to the National Institute of Mental Health, depression affects approximately 16 million adults in the U.S.1, with approximately 2.5 million adults treated with adjunctive therapy.2,3 Depression is a condition characterized by symptoms such as a depressed mood or loss of interest or pleasure in daily activities most of the time for two weeks or more, accompanied by appetite changes, sleep disturbances, motor restlessness or retardation, loss of energy, feelings of worthlessness or excessive guilt, poor concentration, and suicidal thoughts and behaviors. These symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The majority of people who suffer from depression do not respond adequately to initial antidepressant therapy.4

TNX-601, is a novel proprietary oral formulation of tianeptine oxalate.

What makes TNX-601 unique?

Tianeptine oxalate is a novel polymorph and salt of tianeptine, discovered and characterized by Tonix to improve stability, consistency and manufacturability;

Tianeptine sodium (trade names Stablon® and Coaxil®) has an established safety profile based on its decades of use as an antidepressant in many European, Asian, and Latin American countries, but has never been approved for any indication in the U.S. Several published studies support the potential of tianeptine as a possible effective and safe therapy for patients with PTSD.1,2,3,4

Like cyclobenzaprine, tianeptine shares structural similarities with classic tricyclic antidepressants, but it has unique pharmacological and neurochemical properties.5 Tianeptine modulates the glutamatergic system indirectly and reverses the inhibitory neuroplasticity observed during periods of stress and steroid use. It is a weak mu-opioid receptor (MOR) agonist but does not have significant affinity for known neurotransmitter receptors.

  1. National Institute of Mental Health. (2017). Major Depression. Retrieved from http://www.nimh.nih.gov/health/statistics/major-depression.shtml
  2. IMS NSP, NPA, NDTI MAT-24 month data through Aug 2017.
  3. PLOS One, Characterization of Treatment Resistant Depression Episodes in a Cohort of Patients from a US Commercial Claims Database, Oct 2013, Vol 8, Issue 10.
  4. Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study).