Concerns raised about new depression drug


There were concerns that the drug was overhyped and approved too quickly.

Tuesday March 12 2019

Researchers have said that esketamine, a new drug approved for the treatment of severe treatment-resistant depression by the Food and Drug Administration (FDA) of the US, could give new hope to patients who have not found an effective option.

According to the manufacturer – Johnson & Johnson’s pharmaceutical unit, Janssen – the esketamine nasal spray (brand name Spravato) is designed for those who have tried at least two other medications without results, and could help in combating suicidal thoughts.

The American regulator approved the drug following the recommendation of an expert panel and applied restricted distribution to the drug, including mandating that it only be administered under medical supervision and monitoring. The FDA said that the restrictions were necessary because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by the administration of eskatimine, and the potential for abuse and misuse of the drug.

However, there were concerns that the drug was overhyped and approved too quickly. Kim Witczak, a consumer member of the FDA advisory panel, who voted against approval, cautioned that the rush to get the drug to market meant testing may have been insufficient.

He also said that drug companies were using the “treatment resistant depression” or “breakthrough therapy” tags to obtain FDA fast-tracking and not have to go through more rigorous testing protocols, and that the FDA restrictions were “not enforceable and the drug companies are responsible for managing and reporting to the FDA.”

Janssen said the FDA relied on five studies showing the nasal spray worked more quickly than many currently marketed anti-depressants, which sometimes take several weeks to have an effect. Esketamine is related to ketamine, which is used as an anaesthetic in humans and animals, but also as a narcotic. Janssen also applied for authorisation for Spravato from the European Medicines Agency (EMA) in October.

According to the World Health Organisation, some 300 million people around the world suffer from depression, a disease that severely limits the ability to lead a normal daily life and can in the most severe cases lead to suicide. The UN agency said each year nearly 800,000 people die by suicide, which is the second leading cause of death among 15-29 year olds worldwide.