Dr. Steve Levine says having FDA-approved standards for dosing and administering the new drug should raise standards in the field and drive out some of the bad actors who are not qualified to treat depression.
Some 16 million people in the USA have major depression, and one-third of them have not responded well to available treatments and may therefore be considered to have treatment-resistant depression.
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.
"We know that for someone who has failed two traditional antidepressants, if you try a third of the now approved medications, there's a [small] chance to achieve remission", said Dunn, who served on an FDA advisory panel which recommended approval of Spravato last month by a vote of 14-2.
Due to the high potential risk of misuse of the drug, Spravato will only be available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).
The FDA this week approved a controversial drug to treat depression. The first research in this regard was dated back to 1990s when ketamine was used as an underground rave culture party drug for its ability to produce psychedelic or out-of-body experiences.
Shares of Johnson & Johnson were up slightly following the FDA's approval, inching up 0.18 percent over the two-day trading period to close at US$139.09 on Wednesday (March 6).
The U.S. Food and Drug Administration approved a new anti-depressant with a chemical similar to ketamine.
Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness. In the longer study, patients whose conditions had stabilized and continued to take the nasal spray in conjunction with an oral antidepressant took a "statistically significant longer time" to relapse than patients who received a placebo nasal spray with their oral antidepressant.
A clinical trial patient known as Robin P said the drug had a positive impact on him. J&J priced the drug at a wholesale acquisition cost of $590 to $885 per treatment session, depending on which dose patients receive.
The pharma said it was working to educate and certify treatment centers for Spravato. It did not, however, reveal the drug's list price. After receiving a Spravato dose, a patient must be monitored by a healthcare provider for at least two hours.