Ketamine-Like Nasal Spray for Depression Approved by FDA
The FDA approved a new nasal prescription drug called Spravato (Esketamine), similar to the street drug Ketamine to help treatment-resistant depression. Ketamine is a popular party drug that also goes by the street name of “Special K.” The drug is a newly approved nasal spray for treatment-resistant depression, defined as those diagnosed with major depressive disorder who have tried and received no benefit from at least two antidepressant medications.
In clinical trials, six of the patients died while taking the drug, with three of the deaths caused by suicide. However, the FDA states that the deaths of those related to the clinical trial could not be considered “drug related” due to other influencing factors.
Concerns for the drug’s misuse and abuse due to the Ketamine association has created a need for strict guidelines for administration and regulation of the drug. The new prescription must be administered in a hospital or clinic setting. Due to the risk of intoxication and dependence, patients must be monitored for two hours after the dosage. Spravato may not be self-administered or prescribed for use at home.
Common side effects of Spravato include dizziness, nausea, vertigo, anxiety, lethargy, increased blood pressure, vomiting, feeling drunk, decreased sensitivity, sedation and dissociation, a feeling of being temporarily disconnected from your body and your mind. The drug label will contain a boxed warning to alert patients to the risk of sedation, and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug, the agency said in its announcement.
The nasal spray prescription is used to treat serious treatment-resistant depression that has not responded to other medications. Esketamine is a nasal spray that operates quickly with the blood vessels in the nose that allows the drug to start acting immediately, as opposed to an oral tablet that might take multiple weeks to start changing the serotonin levels in the body through the bloodstream. Depending on the severity of the depression, the treatment is given either once a week or every two weeks. Only one other drug known as Symbyax, has been approved for treatment resistant depression.
Spravato has had limited clinical testing with three randomized blind clinical trials that lasted for four weeks, and one longer clinical trial seeking to study the long-term effects of the drug. Some patients saw benefits in as little as two days. According to CNN, currently available treatments for major depression are ineffective in 30-40% of patients. Major drug-resistant depression is a serious condition that can have life altering consequences or lead to the ultimate loss of life through suicide. The hope is that with a new fast acting drug, patients who were previously expereing drug-resistant depression and were not responding to treatment may now have a new rapid release option that potentially could reduce the risk of death from suicide.
Spravato is controversial and has high risks, but brings with it the hope of treating patients who are otherwise unresponsive to medications and treatment in a fast-acting short term treatment that could radically change the positive outlook for those facing treatment resistant depression.