A Timeline of New Psychedelic Therapy Options

Prompted by a TV news report about the FDA’s approval of yet another psychedeleic antidepressant, I thought it might be a good idea to group all these breakthroughs together to compare and contrast. 

If you’re out of the loop on this front, let me bring you up to speed quickly. In short, it turns out that the hippies were right: using psychedelic drugs is a mind-blowing experience. Street drugs like LSD, Ecstasy and Super K have been approved by the FDA for use to treat “treament-resistant” patients. These drugs are administered in a clinical setting using micro-doses. Typically, the patient is under supervision for 2 hours after the dosing. There is a treatment pattern and the results are immediate and durable. 

On the downside, they are expensive and not covered by insurance. 

Here’s our recap timeline of the new psychedelic therapy options:

MARCH 5, 2019

Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression).

Ketamine is approved and labeled by the U.S. Food & Drug Administration (FDA) for both of these uses in the United States. Ketamine was originally developed as an anesthetic and an analgesic or pain reliever.

Prazosin was approved for the treatment of high blood pressure in 1976 but it is now mostly used for the treatment of nightmares in patients with post-traumatic stress disorder, a use that was not originally approved.

AUGUST 2018

The US Food and Drug Administration (FDA) has granted approval to COMPASS Pathways’ planned clinical trial to test psilocybin therapy in patients with treatment-resistant depression.

The phase 2b dose-ranging trial will involve 216 patients across 12-15 research sites in North America and Europe, beginning in the UK later this month. Federal regulatory agencies have already granted approval for such a trial in the UK, Canada, and the Netherlands.

 

AUGUST 8 2006

Ketamine Found to Give Almost Immediate Relief for Severe Depression
Symptoms of depression can be made to disappear in less than two hours with a common anesthetic, not the weeks or months required for onset of relief with traditional antidepressants, according to results of a pilot study.

FEBRUARY 29 2008

FDA Approves Wyeth’s Pristiq
Desvenlafaxine is an antidepressant (serotonin-norepinephrine reuptake inhibitor type-SNRI) used in the treatment of depression.

It works by restoring the balance of natural substances (neurotransmitters such as serotonin and norepinephrine) in the brain. Desvenlafaxine may improve your mood, feelings of well-being, and energy level. Pristiq is a medication licensed for the treatment of depression. By blocking the reuptake of serotonin and norepinephrine in the brain, the drug can help improve symptoms. Pristiq, which is available by prescription only, comes in the form of an extended-release tablet, and is generally taken once daily. Potential side effects include dizziness, insomnia, headaches, and nausea.

DECEMBER 29 1987

FDA Approves Lilly’s Prozac
Prozac is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Prozac affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Prozac is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Prozac is sometimes used together with another medication called olanzapine (Zyprexa) to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Here’s a portion of the FDA’s March 5, 2019 Press Announcement

 

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). 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).

Patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment are considered to have treatment-resistant depression.

The patient self-administers Spravato nasal spray under the supervision of a health care provider in a certified doctor’s office or clinic, and the spray cannot be taken home. The health care provider will instruct the patient on how to operate the nasal spray device. During and after each use of the nasal spray device, the health care provider will check the patient and determine when the patient is ready to leave.

The most common side effects experienced by patients treated with Spravato in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

Esketamine is the s-enantiomer of ketamine. Ketamine is a mixture of two enantiomers (mirror image molecules). This is the first FDA approval of esketamine for any use. The FDA approved ketamine (Ketalar) in 1970.

 

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