FDA Announces Approval of Esketamine Nasal Spray For Treatment of Drug Resistant Major Depressive Disorder

Yesterday, the FDA approved the Janssen Pharmaceutical Companies of Johnson and Johnson product SPRAVATO™, an esketamine nasal spray for the treatment of patients with major depressive disorder. Esketamine was endorsed by an FDA panel in a 14-2 vote in favor of the drug, due to their determination that the benefits of the nasal spray outweighed the risks. Despite the fact esketamine only had one positive short-term phase 3 trial.

In the FDA press release, Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research spoke on the approval saying, “There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition. Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. 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."

However, the similarities to ketamine present potential risks such as disassociation, sedation, and out of body experiences. While ketamine has been prescribed for off-label use it also is known for its misuse as the illicit party drug “Special K”. This has put a lot of pressure on the regulation of the drug, leading to the consensus that it can only be administered by a healthcare professional in approved treatment centers. And the patient will have to stay until the administrator of the esketamine deems they are ready to leave.

“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, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. With other professionals echoing her sentiments. 20 years ago Dr. Dennis Charney was part of the team that originally showed ketamine could be a possible treatment option for patients with major depressive disorder. Speaking with NPR he said, “This is potentially a game changer for millions of people. Many of [the patients] are suicidal, so it's essentially a deadly disease when you haven't responded to available treatments and you've been suffering for years if not decades."

Esketamine works through different mechanisms compared to other traditional anti-depressants and studies have shown that it can provide relief for patients within hours. Instead of the week, or weeks, it may take for other drugs. This approval also comes at a time where generic versions of ketamine is actively being used by physicians to treat depression and other disorders where depression is a symptom. With many ketamine clinics popping up across the country, yet treatment expenses can be up to $500 to use ketamine and the use if esketamine will cost in the range of $590-$885 depending on the dose.