Breakthrough nasal spray for depression not without risks

While there are potential serious adverse outcomes from use of a new nasal spray to treat depression, it is being lauded as a breakthrough treatment.

FDA approved esketamine (Spravato, Janssen) nasal spray, in conjunction with an oral antidepressant, to treat depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). This is the first FDA approval of esketamine for any use, and it received fast-track and breakthrough therapy designations.

However, 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),” FDA said in a statement.

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“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. “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 healthcare provider can monitor the patient."

Controlled clinical trials that studied the safety and efficacy of Spravato, along with careful review through the FDA’s drug approval process-including a robust discussion with the agency’s external advisory committees-led to FDA’s decision to approve this treatment, Farchione added.

"In phase 3 clinical trials, we saw this therapy provide sustained improvement to patients with treatment-resistant depression,” said Michael E. Thase, MD, site principal investigator for the clinical trials and a professor of psychiatry and director of the Mood and Anxiety Disorders Treatment and Research Program in the Perelman School of Medicine at the University of Pennsylvania, in a Janssen statement.

Janssen is working quickly to educate and certify treatment centers in accordance with the REMS so healthcare providers can offer Spravato to appropriate patients.

The wholesale acquisition cost (WAC) of Spravato is $590 to $885 per treatment session, based on the clinical need to treat a patient with the 56 mg or 84 mg dose kit, Kristina Chang, business unit communication leader, Neuroscience and Infectious Diseases at Janssen, told FormularyWatch.

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Later this month, patients can visit www.SPRAVATO.com for a locator tool and to sign up to receive alerts when new treatment centers are available, Janssen said in its statement. “More locations will be added over time as new treatment centers become certified.”

Spravato labeling contains a Boxed Warning that cautions that patients are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.

Because of the risk of sedation and dissociation, patients must be monitored by a healthcare provider for at least two hours after receiving their Spravato dose. Spravato must also be dispensed with a patient Medication Guide that outlines the drug’s uses and risks.

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 healthcare provider instructs the patient on how to operate the nasal spray device. During and after each use of the device, the healthcare provider will check the patient and determine when the patient is ready to leave, FDA said.

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.

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