Spravato, which is administered via a nasal spray, is the first FDA-approved antidepressant in over 30 years.

Big Pharma Johnson & Johnson (NYSE:JNJ) received a crucial decision on Tuesday (March 5) from the US Food and Drug Administration (FDA) for Janssen Pharmaceuticals’, a division of Johnson & Johnson, nasal spray called Spravato.

The drug is to treat severe symptoms of depression, including adults with treatment-resistant depression (TRD). Spravato is a brand name for esketamine and is closely associated with anesthetic ketamine—a party drug otherwise known as ‘Special K.’

This is the first new depression treatment that has been approved by the FDA in over 30 years, but is highly controversial due to its chemical similarities to ketamine and the FDA’s Boxed Warning on the treatment.

According to the FDA’s announcement, because of the serious risks associated with the drug, including sedation, dissociation and potential abuse and misuse of Spravato, patients can only get it through a restricted distribution system.

In addition to the risks mentioned above, Spravato’s warning label alerts patients could be at risk for having troubles with attention and suicidal thoughts and behaviors after the drug has been taken. Because of this, patient are required to be monitored by a health care professional for at least two hours after Spravato is administered and will be used in connection with an oral antidepressant, the FDA said.

Tuesday’s approval comes after an FDA Advisory Committee recommended the approval of Spravato in a 14-to-2 vote in favor of the drug in February. Spravato is intended to treat patients who have major depressive disorder (MDD) and have not responded “adequately” to two at least two different types of antidepressants. TRD is classified as a chronic condition which has an ongoing emotional, function, and economic burden on the individual.

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement.

In a separate release issued by Johnson & Johnson on Tuesday, the company said the drug was studied in a Phase 3 clinical trial with over 1,700 patients with TRD. A short-term study showed that those who took the drug and an oral antidepressant demonstrated a reduction in depression symptoms at four weeks when compared to those that received a placebo and an oral antidepressant.

A long term study of the drug showed that patients in stable remission taking the drug that continued the treatment were 51 percent less likely to relapse as compared to those who continuously took a placebo with an oral antidepressant.

The FDA approval is a significant milestone not only for the company but for those living with MDD. According to Johnson & Johnson, at least one-third of US adults who have MDD also have TRD.

According to Business Insider, the cost of the drug isn’t cheap: the price tag ranges anywhere between US$590 to US$885 per treatment session, depending on how high of a dose a patient needs. During the first month, a patient will have two sessions per week ranging between US$5,000 and US$5,000. By the second month, a patient will receive treatment once a week or every two weeks, which will reduce the cost to between US$2,3000 and US$3,500 per month.

The approval of Spravato could potentially open the door for other types of antidepressant approvals in 2019, particularly in postpartum depression. Sage Therapeutics (NASDAQ:SAGE), for example, revealed in January that its drug, SAGE-217 met primary and secondary endpoints in a Phase 3 clinical trial to treat postpartum depression. The results demonstrated that the drug helped relieve symptoms of postpartum depression in approximately 150 women.

Meanwhile, Marinus Pharmaceuticals (NASDAQ:MRNS) announced in December that its Phase 2 clinical trials in women with postpartum depression demonstrated safety, tolerability and efficacy, which allowed the company to advance into the next stage of development.

In short, approvals for antidepressants have been few and far between, but with the rising number of people suffering depression, the antidepressant market is undoubtedly poised for growth. According to a report from Allied Market Research, the global antidepressant market totaled US$14.11 billion in 2017, and is expected to reach US$15.98 billion by 2023 and growing at a compound annual growth rate (CAGR) of 2.1 percent during the forecast period.

The report says that an increase in depression, a rise in geriatric population and “the emergence of innovative techniques for the development of drugs with fewer side-effects” will be the largest factors pushing the market’s growth.

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).

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Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.


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