Written by by Hayley Spender, CNN
The US Food and Drug Administration (FDA) has approved a new pill to treat early depression. But before you can take the drug, you may need to travel to London.
The FDA has approved a low dose of ergotamine succinate, the active ingredient in the drug Revolixys, for the treatment of minor depression in adults up to the age of 59. The three-milligram pill has already been available in the UK for some time — FDA approval was based on clinical trials conducted in the UK and the Netherlands.
A press release from Revolixys’ manufacturer, Teva Pharmaceutical Industries , states that the drug is “similar to existing antidepressants and is approved for patient use based on the same safety and efficacy studies as existing anti-depressants in the same indication.”
Alegotamine sulfate acts on serotonin receptors, and the FDA says its benefits outweigh its risks. The regulator added that it “does not impact the number of visits to the physician or hospital.”
The pill is touted to be more affordable than other antidepressants. In 2017, a comparable pill for depression was estimated to cost around $250 per month, according to Drugreferral.net.
Made by Teva Pharmaceutical Industries, the low dose of ergotamine succinate is known as Revolixys, and has been made available in the UK for some time. Credit: courtesy laslucavia
FDA approval is not the end of the road for the treatment. It is currently approved for the UK market, and doctors can prescribe the drug for patient use. The UK’s National Institute for Health and Care Excellence (NICE) has also made it available for private use.
This is the first time that an ergotamine succinate drug has been approved for depression. A previous study, using a different type of ergotamine sodium, showed positive results for the drug, when it was tested on children. The study, conducted in Holland, claimed that the drug reduced the onset of symptoms and the intensity of symptoms by over half.
And yet, the drug is often on the receiving end of skepticism by critics who have raised concerns over its long-term use. In 2013, a report published in the journal Pediatrics discovered that although several people had been treated with ergotamine succinate, no long-term studies have been conducted.
In July, a federal judge ruled that Teva Pharmaceutical Industries was liable for more than $600 million in damages stemming from deaths linked to the original version of the drug. This ruling came after a lawsuit against the pharmaceutical company for allegedly manufacturing, marketing and selling a drug the federal government claimed was dangerous.