In the longer-term maintenance-of-effect trial, patients who continued the use of Spravato experienced a statistically significantly longer time to relapse of depressive symptoms than patients on placebo nasal spray and oral antidepressant.
The US Food and Drink Administration (FDA) yesterday licensed the nasal spray for use by those who have already tried at least two medications for depression, without success. Prozac, like other anti-depressants, affects the brain chemical serotonin.
In the clinical trials, the most common side effects of Spravato when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure, vomiting, and feeling drunk.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition", said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Centre for Drug Evaluation and Research. This spray is a chemical cousin of ketamine that has been used for decades as an anesthesia for surgery patients. The drug is a nasal spray created to treat severe forms of depression that don't respond to other treatments.
The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates. They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days. "We have carefully reviewed the drug, and it met our criteria to get approved for depression treatments".
Unlike ketamine, psilocybin and MDMA have no legal medical use. After receiving a Spravato dose, a patient must be monitored by a healthcare provider for at least two hours.
The drug will come with a label warning patients that it has the potential to be abused or misused.
There's a new ally in the ongoing battle against depression that doctors say works faster and more efficiently than previous drugs.
Jeffrey Lieberman, a Columbia University psychiatrist, described the FDA approval as "undeniably a major advance".
During the one-month induction phase, treatment with Spravato would cost between $4,720 to $6,785.
Patients will inhale the drug under supervision at these centers once or twice a week.