However, the panel members echoed concerns raised by FDA staffers regarding the increased risk of sedation, dissociation and higher blood pressure observed in the study.
Esketamine is the s-enantiomer of ketamine.
The FDA is requiring patients who are prescribed the drug to be monitored closely, due to the possibility of negative reactions of sedation and disassociation tied to the drug. Like any new medication, it comes with many questions; clinical studies before FDA approval are limited in the number and type of patient they include, meaning that more information only comes to light when new drugs reach the "real world".
The new treatment, which is called Spravato (drug name esketamine) is a nasal spray that is meant to influence the NMDA receptor in the brain that has been linked to depression. Ask your doctor for more information.
People who are now struggling with MDD are considered to have TRD if they have not responded adequately to at least 2 different antidepressants of adequate dose and duration in the current depressive episode.
Jan-Michael Vincent, star of 'Airwolf,' dead at 73
Vincent battled with alcohol and substance abuse, having been arrested for possession of cocaine and bar brawls various times. Vincent also starred in films like The Mechanic (1972), Damnation Alley , Hooper (with Burt Reynolds ), and Buffalo '66.
Snow forecast for parts of country this weekend
Before heavy rain moves into our area we'll get another blast of winter snow tonight in Cuming County. Following a messy afternoon and evening, rain showers are expected across the area Saturday night.
Crew Dragon Returns to Earth
SpaceX CEO Elon Musk also included a small "zero gravity sensor" in the shape of an Earth-shaped plush toy. But the capsule was also responsible for delivering supplies to the International Space Station.
"Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies", said Mathai Mammen, global head of J&J's Janssen Research & Development.
"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.
According to Janssen, treatment costs will depend on dosage and range from $590 to $885 per treatment session. In some patients, this improvement was observed within a few days. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months.
The drug will be administered at clinics under supervision.
But he hopes that doctors who are now using ketamine continue to do so.
For the first time in years, the FDA has approved a new anti-depressant - a nasal spray called esketamine.
"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.