in Life Sciences

The FDA approved Spravato (esketamine) on March 5, 2019, as a treatment for Treatment-Resistant Depression (TRD).

This nasally inhaled drug, along with the use of oral anti-depressants, helps to give patients with TRD the ability to improve their mood and reduce relapses.

Janssen Pharmaceuticals Inc. developed Spravato as the first advancement of a new mechanical action to treat Major Depressive Disorder (MDD) in the past few decades.

Treatment

Spravato is taken along with an oral anti-depressant and is only allowed to be administered in the presence of a medical professional in a certified medical office. The patient must be monitored in the office for at least 2 hours after taking the drug.

“Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).”

FDA

How it works

Esketamine (C13H16CINO.HCI) is a non-competitive antagonist of N-methyl-D-aspartate (NMDA) which is an ionotropic glutamate receptor. This form of antagonist allows the glutamate receptor to receive the oral-antidepressants more effectively. The active receptors both increase the immediate effects of the oral treatment and helps to regulate a healthy balance of neurotransmitters, long-term.

Clinical Trials

Three short-term groups of participants diagnosed with TRD started a new anti-depressant medication along with either Spravato or a placebo. One of the three groups showed a statistically significant decrease in depressive symptoms for those that recieved Spravato.

In a long-term study, those patients who received Spravato were 51% less likely to relapse than those taking the placebo. In total, these results include data from one thousand seven hundred adults.

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Global Presence

Major Depressive Disorder affects 6.7% of the United States’ population and over 300 million people worldwide.

Drugs like Spravato can have a global effect on lifestyles and patient care in a market such as China which has over 54 million patients diagnosed with some form of depression. The mental health market is currently one of the fastest growing markets in China which is in response to the recently passed Mental Health Law. This new law boosts the amount of access to treatment and development in the field of psychology.

CSOFT International has experience helping some of the largest pharmaceutical companies to enter into the international market. Their field-specific translators work closely with the NMPA (also known as the CFDA) to translate research and medical documents to meet approval requirements. With growing markets like China’s, pharmaceutical companies can expand drugs such as Spravato, internationally.

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