The FDA has recently announced that it has approved the drug “esketamine”, which can be used in patients with depression that’s resistant to other treatments. The drug, which is called Spravato, is related to ketamine and will be available in the form of a nasal spray.
Currently, according to the FDA, traditional treatments for depression are ineffective in as many as 40% of cases. The WHO estimates that over 300 million people are affected by depression globally, including 16.2 million in the US. That equates to around 6.7% of the American population.
Although the new drug has been branded a “breakthrough” by the FDA, health groups have raised concerns over the potential side effects, as well as the possibility that it could be misused by some patients, as it’s so similar to ketamine.
The FDA says that, to reduce these risks, boxes will contain warnings of the risks, which include “sedation, and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.”
In addition, the drug will only be administered in medical clinics, and not at home. It will be administered either by a healthcare worker, or it can be self-administered under supervision. Patients will then be monitored for at least two hours after taking it.
Spravato will be used in patients who have severe depression that hasn’t responded to other treatments. It will be taken alongside an oral antidepressant either once a week or twice a week, depending on how severe the symptoms are.
Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation and Research said in a news release. “There has been a longstanding need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition.”
She added: “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.”
A spokesperson for Janssen Pharmaceuticals Inc., which manufactures the drug, said: “We are working quickly to educate and certify treatment centers on the unique administration requirements of SPRAVATO™ to ensure patients can access this important medicine.”