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Federal regulators have just given the green light to a second new type of antidepressant this month, after decades of weak progress in fighting the disease.
The US Food and Drug Administration on Tuesday approved a Zulresso brand injection made by biotech company Sage Therapeutics. The drug, known as brexbadone, treats people with depression after childbirth, a condition known as postpartum depression (PPD).
"This approval marks the first time that a drug has been specifically approved to treat postpartum depression, offering a significant new treatment option," said Tiffany Farchione, Acting FDA Director in the Products Division. psychiatry, in a statement.
About two weeks ago, the FDA approved a treatment for severe depression called esketamine from Johnson & Johnson.
Unlike the 35-year-old depression medication, none of the newer drugs is a pill. One is a nasal spray and the other is an injection.
New approaches to treating depression, a disease that affects 16 million Americans
Both drugs bring a new approach to the treatment of depression that has not been seen by other approved drugs. Instead of focusing on the brain's serotonin network – like all available drugs over the past four decades – new drugs focus on single parts of the brain that are thought to affect our mood.
Because of this, the reviewers hope that the drugs will offer faster and more durable solutions – mainly to people who have tried unsuccessfully to see the benefits of existing drugs.
Sage's drug affects Gaba's brain network, believed to play a role in anxiety. It was created for mothers with postpartum depression. It is estimated that the PPD affects up to 400,000 Americans each year.
Esketamine, a Johnson & Johnson drug, is inspired by ketamine and acts on a brain system known as the NMDA system. It is designed to treat severe depression.
One of the biggest potential benefits of Sage's drug is the fact that it would not need to be taken daily, like a traditional antidepressant. It also seems to work quickly, taking effect in a few hours, unlike today's depression tablets, which can take weeks to begin functioning. The effects of Zulresso can last up to 30 days, the period of time that researchers have badyzed for clinical trials of the company.
Sage's new drug could also be very expensive. The company has announced that it will charge $ 34,000 for treatment, and it is still unclear how much of this insurance would cover.
The treatment should be administered to patients intravenously and the dosage should last two and a half days. This means that a patient should go to a clinic and spend the night under the supervision of a professional.
The company is also studying a tablet version of its new injectable instrument in a broader set of mental illnesses, including major depression and bipolar disorder. Analysts expect this drug, known as Sage-217, to have a resounding appeal to 16 million Americans suffering from severe non-childbirth-related depression.
The official approval of brexanolone follows a favorable vote from outside experts convened by the FDA last fall. In November, the panel voted 17 to 1 in favor of treatment, which they said had more benefits than risks for patients. Nevertheless, the new drug has significant risks and side effects.
Experts are optimistic about Sage's new injectable drug, but they are more excited about the pill.
Analysts and clinicians have expressed hope for this new approval for several reasons. They believe that this adds options for a disease for which no drug has yet been approved. They are also waiting for the drug badociated with Sage to be well advertised – the oral pill called 217, which is at an early stage of research but is targeting the same part of the brain as the injection.
Together, Zulresso and 217 "have the potential to change the paradigm of treating mood disorders," writes Yatin Suneja, a biotech badyst for investment company Guggenheim, in a report released last month. Suneja added that the company expects both drugs to generate sales in the range of US $ 3 billion to US $ 5 billion for all diseases, including major depression, PPD and the disorder. potentially bipolar.
Assuming 217 is also approved, Sage considers that both drugs help provide more options for people with mental illness.
"We believe these two products can live in this market and help create a choice for patients," Sage Commercial Director Michael Cloonan told Business Insider.
Sage's new drug may have a serious side effect
Brexanolone is badociated with side effects such as headache, drowsiness, and dizziness. In addition, out of 140 women who received the drug during a clinical trial, six of them temporarily lost knowledge during treatment, according to data compiled by the FDA before the panel of experts gathered last fall.
Although the potential side effect is serious, the panel convened by the FDA also stated that it was the only "major safety issue" observed with Sage's drug. To address this, regulators will require patients to visit approved drug clinics where they can be monitored for several days.
Wall Street badysts expect the recent approval to also bode well for Sage's oral drug candidate, 217.
A drug that works differently from all existing depression medications has just taken a new impetus
Unlike brexanolone, 217 could be taken by mouth without resorting to specialized clinics. In addition, 217 is in the study for use in a wide range of brain diseases, including major depressive disorder, bipolar disorder, and insomnia.
"The possibility of having an impact on the Gaba system is appealing, because if you start it tomorrow, many patients may not have access to all that is available," said Paul Matteis, general manager of the biotechnology research. Stifel brokerage firm, said Business Insider.
And like the injection of Sage, the oral pill can act faster than traditional medicines and does not require daily dosing. In clinical trials involving patients who took the drug once, its effects seemed to last as long as four weeks.
It's something that, according to Matteis, would be "preferred by most patients [over] have to take something indefinitely. "
"We are trying to change the paradigm," said Cloonan. "We want patients to take this medicine when they need it, not when they do not."
This article was originally published by Business Insider.
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