A nasal spray containing chemicals closely related to ketamine has been approved for use in the US in the treatment of depression – but it will be highly regulated to avoid misuse of the drug.
The nasal spray, from Johnson & Johnson, has been approved for use by the US Food and Drug Administration (FDA) and is the first treatment to tackle depression in a new way for decades.
Under the brand name Spravato, the drug (which has the chemical name esketamine) will be prescribed to adults who have tried other antidepressant medicines but not benefited from them.
The medication is absorbed by the lining of the nasal passages and into the blood stream. It then influences the N-methyl-D-aspartate (NMDA) receptor in the brain, which has been linked to depression.
According to the FDA, trials of the spray demonstrated a “statistically significant effect compared to placebo on the severity of depression” with some effects noted within two days. In comparison, many antidepressants currently available can take weeks, or even months, to have an effect.
A clinical trial patient known as Robin P said the drug had a positive impact on him. “When I began treatment with esketamine and my symptoms started to lift, I could see very clearly just how depressed I had been,” he said. “I’m now able to appreciate a wider range of emotions than when I was depressed. My long-term goals have taken shape and actually seem attainable.”
Jeffrey Lieberman, a Columbia University psychiatrist, described the FDA approval as “undeniably a major advance”. However, he cautioned that we do not know much about the long-term impacts of the drug, telling the Washington Post: “Doctors will have to be very judicious and feel their way along.”
The nasal spray must be taken by patients under the supervision of a healthcare provider in a certified doctor’s office or clinic and the spray cannot be taken home.
Patients will then have to remain at the clinic for two hours after using the spray to be monitored by a professional “because of the risk of sedation and dissociation”.
Other side effects experienced by some patients treated with the spray in the clinical trials were dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.
The makers of the nasal spray told HuffPost UK they submitted an application to the European Medicines Agency (EMA) in October 2018 seeking approval for the medication to made made available in Europe (including the UK). This is now due to be reviewed by the Committee for Medicinal Products for Human Use (CHMP) .
“If successfully approved, European marketing authorisation (including the UK) would be granted,” a spokesperson said. “We cannot speculate on timelines related to the EMA decision nor the impact of any potential future changes to this process post-Brexit.”
Useful websites and helplines:
- Mind, open Monday to Friday, 9am-6pm on 0300 123 3393
- Samaritans offers a listening service which is open 24 hours a day, on 116 123 (UK and ROI - this number is FREE to call and will not appear on your phone bill.)
- The Mix is a free support service for people under 25. Call 0808 808 4994 or email: help@themix.org.uk
- Rethink Mental Illness offers practical help through its advice line which can be reached on 0300 5000 927 (open Monday to Friday 10am-4pm). More info can be found on www.rethink.org.