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Head-to-head challenges win, but fight poison with poison. Can excellent clinical data turn psychedelics around?

 Last Update: 2023-01-05
 Source: Internet
 Author: User

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On November 23, 2022, Johnson & Johnson subsidiary Janssen released new Phase 3 clinical data
for the antidepressant drug Spravato.

Janssen announced that Spravato nasal spray outperforms serquel sold by AstraZeneca when it comes to treating treatment-resistant depression (TRD).
XR (i.
e.
quetiapine sustained-release tablets).

Among the 676 adult patients, patients treated with Spravato achieved remission and avoided relapse at a significantly higher rate than its control group
.

When it comes to treating treatment-resistant depression (TRD), Spravato nasal spray outperforms serquel sold by AstraZeneca XR (i.
e.
quetiapine sustained-release tablets).

Among the 676 adult patients, patients treated with Spravato achieved remission and avoided relapse at a significantly higher rate than its control group
.

Patients in this clinical trial failed
at least two other treatments.
Both agents are used in combination with a continuous selective serotonin reuptake inhibitor (SSRI) or with serotonin and norepinephrine reuptake inhibitors (
SNRIs).
Treatment-resistant depression (TRD) is a broad category
.
Patients who do not respond well to two antidepressants are classified as TRD
.

Clinically, about one-third of patients are classified as TRD, which means that a significant number of depressed patients cannot find suitable antidepressants
.
According to Johnson & Johnson data, at week 8, 27.
1 percent of patients in the Spravato group were in remission, compared with 17.
6 percent in the control group (p=0.
003)
。 Of the Spravato participants who were in remission, 21.
7% had no recurrence at week 32, compared with 14.
1% of the control group (p=0.
008)
。 By week 32, approximately 55% of Spravato subjects achieved remission and only 37% (p<0.
001)
of quetiapine participants.

Approximately one-third of patients are clinically classified as TRD

Although the drug has remarkable efficacy and wins the head-to-head challenge, its marketing and clinical application may still be hindered
.
In 2019, the FDA approved Sparavato for the treatment of major depressive
disorder with TRD and impending suicide risk.
However, the drug is still mired in a spiral of controversy
.

The reason is that esketamine, the main ingredient of Sparavato, is an isomer
of the drug ketamine (that is, the drug "K powder").
Compared with ketamine, esketamine is more effective
in NMDA receptor antagonism.
But eketamine, like its twin "K powder," may lead to drug addiction
with long-term use.
There are side effects such as dizziness, nausea, and increased blood pressure, as well as potential hallucinogenicity, schizophrenia and other serious adverse effects
.
Concerns about drug abuse and strong side effects make it difficult for patients to obtain permission
to use the drug.

The reason is that esketamine, the main ingredient of Sparavato, is an isomer
of the drug ketamine (that is, the drug "K powder").

Just last week, Sparavato was again rejected by NICE
.
Before that, Janssen had made several attempts
.
Despite Janssen's attempt to appeal NICE's draft guidance, NICE said in last week's final evaluation document that it does not recommend the use of Spravato
in patients with treatment-resistant depression if at least two other antidepressants are ineffective.
NICE wrote that Janssen targeted Spravato to people who had previously taken at least 3 antidepressants, regardless of other treatments
such as lithium or antipsychotics.

Just last week, Sparavato was again rejected by NICE
.

This is narrower
than the way marketing authorization and clinical experts recommend that ketamine may be used in NHS practice guidelines.
The clinical application of psychedelics flourished in the middle of the last century and ended in the seventies of the
last century.
The United States introduced the Controlled Substances Act, which included LSD in the scope of primary control; In 1971, the United Nations Convention on Psychotropic Substances imposed severe restrictions
on LSD.
After entering the new century, psychedelic related experiments surged again, and the iron law was slightly relaxed
.

Some pharmaceutical companies have begun to explore "forbidden areas", and even companies focused on the development of psychedelics have IPOs
on the NASDAQ.
A large number of unmet clinical needs have to require some "desperate" drugs, and psychedelics are one of
them.
For patients in despair, even LSD can be a lifesaver
.

That's
why the 2019 FDA Expert Advisory Committee finally voted to approve the drug.
The aftermath should be left to strict drug control and longer-term medical observation, and this is not something that can be explained by a head-to-head challenge
.

Resources:

1.
J&J’s Spravato pulls a PhIII win against Seroquel XR in treatment-resistant depression – Endpoints News (endpts.
com)

2.
Can LSD under first-level control become a savior in the field of mental illness? (same as freehand)

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