"This is going to bring in some standards, regulation and it's going to make it safer and more accessible to patients", said Levine, who serves as vice president of the American Society of Ketamine Physicians, a group representing doctors, nurses and others using ketamine for treating depression or other nonapproved uses. "Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient". Still, ketamine has always been explored as a potential treatment for depression due to its ability to relieve symptoms within hours.
"The fact that esketamine works differently than our current medications for the treatment-resistant population offers more hope", Walter Dunn, staff psychiatrist and assistant clinical professor at the University of California, Los Angeles, said in an interview with BioPharma Dive.
Spravato is a chemical mirror image of anesthetic ketamine, which is abused as a recreational party drug that goes by the street name Special K. Dunn voted in favor of the drug. It then influences the N-methyl-D-aspartate (NMDA) receptor in the brain, which has been linked to depression.
This photo provided by Janssen Global Services shows Spravato nasal spray.
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.
The FDA's approval clears Spravato for use in conjunction with an oral antidepressant.
The drug's approval came after only one positive short-term phase III trial. They also said they believed esketamine's benefits outweighed its risks. Researchers are conducting late-stage trials of psilocybin, the active ingredient in magic mushrooms, and MDMA, a euphoria-inducing club drug, as potential treatments for depression and post-traumatic stress disorder. The drug can not be taken home for unsupervised use.
For J&J, Spravato's approval represents a significant addition to its portfolio of neuroscience drugs, which includes Concerta (methylphenidate) and Risperdal (risperidone). Spravato could be available within days at centers to complete the REMS certification. It has been slated to cost around $885 (£673) per treatment. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000.
Subsequent maintenance doses will be provided either once a week or every two weeks, adding up to monthly costs ranging from $2,360 to $3,540.