March 6 (UPI) -- The U.S. Food and Drug Administration has approved a prescription-only nasal spray to treat depression -- marking the first medical advancement in fighting the affliction in more than 30 years.
The agency approved Johnson & Johnson's Spravato, which will carry the FDA's strongest box warning due to abuse potential. The warning highlights risks that include sedation and difficulty with attention, judgment and thinking, abuse and misuse and suicidal thoughts. Spravato is similar to ketamine, which has been cited in past abuse cases and is known by the slang name "Special K."
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," FDA Dr. Tiffany Farchione said in a statement.
Johnson & Johnson said the nasal spray will be distributed by prescription via a tightly-monitored system.
"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," she added.
The FDA said patients with unstable or poorly-controlled hypertension or pre-existing aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects from using the drug. The agency warned against pregnant women using the drug.
Janssen Pharmaceutical, a division of Johnson & Johnson that developed the drug, said the new medication will be used in conjunction with an oral antidepressant in adults with treatment-resistant depression.
"Depression is a common and potentially debilitating illness that can have profound emotional, functional and economic impact on both those who suffer and their loved ones," said University of Pennsylvania Dr. Michael E. Thase, a principal investigator for the drug's clinical trials.
"The impact of depression is greatest for those who do not benefit from standard treatments. In Phase 3 clinical trials, we saw this therapy provide sustained improvement to patients with treatment-resistant depression," he added in a statement from Janssen.