Recent developments in the development of new drugs for depression

November 18, 2023

June 12, 2018 Source: Sina Pharmaceutical

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Depression is the most common mental illness with a significant and persistent low mood as the main clinical feature, which seriously affects physical and mental health and can cause great pain to patients and their families. Worst of all, depression can lead to suicide. According to WHO statistics, there are as many as 350 million people with depression worldwide. It is expected to become the world's second largest disease in 2020, with an annual death toll of 1 million due to depression. China is a big country with depression. The number of patients has reached 90 million, and the rate of medical treatment is less than 10%. About 280,000 people commit suicide each year in China, and most of them are diagnosed with depression.

Currently, there are two major classes of antidepressants on the market, one is selective serotonin reuptake inhibitors (SSRIs), such as Prozac and Zoloft, and the other is 5- Serotonin norepinephrine reuptake inhibitors (SNRIs), such as Pristiq and Efexor. However, a considerable number of patients still have poor response to these two types of drugs, so the pharmaceutical industry continues to develop better alternative antidepressant therapies. The Biospace website has taken stock of recent advances in the development of new drugs for depression:

1 , AV-101

AV-101 was developed by VistaGen, an oral NMDA receptor glycine binding site antagonist and a new generation of experimental drugs for the treatment of depression.

On April 5 this year, VistaGen announced the launch of a large phase II clinical trial, ELEVATE, to evaluate AV-101 as an adjunct to patients with major depressive disorder (MDD) who are currently underreactive to antidepressants. The study is expected to receive data early next year.

AV-101 has a novel mechanism of action that is distinct from current FDA-approved antidepressants. AV101 targets glutamate, the most common neurotransmitter in the brain. Similar to intravenous ketamine, AV-101 inhibits NMDA receptor activity and is expected to achieve ketamine-like antidepressant effects, but the drug is administered orally without the side effects and safety of ketamine.

2 , ALKS 5461

The drug is a daily oral medication from Alkermes and is currently being developed as adjunctive therapy for MDD patients who are underreactive to standard antidepressant therapy. Clinical trials have shown that oral administration of the drug once a day does not cause addiction. Previously, the FDA had granted the drug a fast-track status. On April 16, the FDA accepted a new drug application for the drug, which is expected to be reviewed on January 31, 2019.

ALKS5461 consists of a fixed dose of buprenorphine and samidorphan (ALKS-33), a buprenorphine is a mu-opioid receptor partial agonist and a functional k-opioid receptor antagonist with a risk of addiction; Samidorphan is a novel selective potent Î¼-opioid receptor antagonist that counteracts the agonist function of buprenorphine, leaving only the k-opioid receptor antagonist function. Combining these two drugs will create a new functional k-opioid receptor antagonist.

ALKS5461 aims to rebalance the brain dysfunction in patients with depression. The drug has a novel mechanism of action and, if approved, will become a new class of antidepressant drugs, the brain's endogenous opioid system modulator. The brain opioid system is a key regulatory system of human emotions and emotions.

3 , SAGE-547

The drug is an intravenous formulation of brexanolone developed by SAGE Therapeutics and is currently being developed for the treatment of postpartum depression (PPD). On May 30 this year, SAGE announced that the US FDA has accepted the SAGE-547 new drug application and granted priority review. It is expected that a decision will be made by December 19, 2018. If approved, SAGE-547 will change the clinical treatment pattern of PPD.

Brexanolone is an allosteric modulator that acts on both synaptic and extrasynaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity can produce various degrees of desired activity, rather than full activation or complete inhibition. In the United States, the FDA has granted SAGE-547 breakthrough drug qualifications; in the European Union, EMA has also been granted priority drug qualifications.

PPD is a common complication of childbirth and is the leading cause of maternal postpartum suicide, which may have disastrous consequences for the patient and the family. Currently, there are no drugs approved for the treatment of PPD, and there are significant unmet medical needs in this area.

4 , esketamine

This drug is a non-competitive antagonist of NMDA receptor developed by Johnson & Johnson. It is a mirror image isomer of ketamine. It has a new mechanism of drug action, which is different from other depression treatments currently on the market. Previously, the FDA had granted esketamine two breakthrough drug qualifications for the treatment of drug-resistant depression and the major risk of suicide.

At present, Johnson & Johnson is developing esketamine nasal spray for the treatment of refractory depression. On the 1st of this month, Johnson & Johnson announced positive data on two long-term phase III clinical studies of esketamine at the annual meeting of the American Society of Clinical Psychopharmacology (ASCP). Safety results were consistent with previous Phase II and Phase III clinical studies. The most common adverse reactions were metallic taste, dizziness, dissociation, lethargy, dizziness, headache, nausea, blurred vision, and tactile or sensory sensation. Most adverse events occur on the first day of dosing and are usually resolved on the same day.

Johnson & Johnson is expected to submit a esketamine listing application in the second half of this year. If approved, it will be the first new drug treatment for refractory depression in 50 years. It belongs to a new class of antidepressants targeting NMDA receptors. .

5 , AKL-T03

This is a digital therapy developed by Akili Interactive, a distinctive antidepressant treatment. Akili is a prescription digital medicine company that combines scientific and clinical rigor with the creativity of the technology industry to reshape medicine. The company is pioneering digital therapies for direct treatment, not through drugs, but through the use of high-quality action video game experiences to treat certain diseases.

Akili's leading product is the AKL-T01, developed for children with attention deficit hyperactivity disorder (ADHD). In clinical studies, this carding therapy improves attention, depression, and working memory in children with ADHD.

On May 9 this year, the company successfully completed the C round of financing of 55 million US dollars. The funds raised will be used to promote the regulatory review of AKL-T01 and the clinical registration of other pipeline products in depression and multiple sclerosis, including AKL-T03, which is currently in Phase II clinical trials for treatment. Cognitive dysfunction in adult patients with depression. Akili expects to release data from the study later this year. (Sina Pharmaceutical Compilation/newborn)

Articles, pictures reference source: Recent Industry Movement Focuses on Depression Treatments

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