FDA Approves Fast-Acting Nasal Inhaler Depression Drug
FDA Approves Fast-Acting Nasal Inhaler Depression Drug
Ketamine-based drug approved for treating severe depression in the US
12 March, 2019, 17:53
Since the 1990s, ketamine has gained notoriety in the underground rave scene as "Special K", which can produce psychedelic effects.
The approval of J&J's modern-day anti-depressant nasal spray marks the first advanced treatment innovated for fighting depression in decades.
The drug, esketamine, which will be sold by Johnson & Johnson as the nasal spray Spravato, has been highly anticipated by psychiatrists as a powerful new tool to fight intractable depression, according to The Washington Post.
Spravato will cost between $590 and $885 per treatment.
Esketamine is created to be administered intranasally twice a week for an initial 4 weeks, in conjunction with a newly initiated oral antidepressant. Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in. Spravato is the first major new depression treatment to be approved by the FDA since Prozac which entered medical use in 1986.
Prozac therapy can take weeks or months to become effective, but Spravato has an nearly immediate effect as it alters the neurotransmitter glutamate, according to researchers. "Also, it seems to work in 24 to 48 hours, so there's a very rapid resolution of symptoms".
The FDA concludes the drug is also being tested in patients with depression who are at a high risk of committing suicide.
Esketamine is the s-enantiomer of ketamine. They pointed to reported trial protocol violations, discrepancies between locked data sets and an unusual response curve shift, whereby a almost significant treatment effect emerged 28 days following initiation of treatment, when for three weeks there was no difference, and the other studies showed an effect after only two days. He said the approval legitimizes the approach he and other doctors have been taking. "That's prompting people to investigate other compounds". Ketamine was approved for use as an anesthetic in the 1970s. Drugmaker Janssen Pharmaceuticals brought five phase III studies to the FDA's advisory committee meeting in February: two of three short-term studies did not meet their primary endpoint, but a flexible dose trial in adults younger than 65 and a withdrawal maintenance-of-effect study were positive.
Depression is among the leading causes of disability in the US and is being closely monitored by health authorities amid rising suicides nationwide.
A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017.
Government officials haven't suggested an explanation for the trend, though academic researchers point to the nation's widening income gap, financial struggles and divisive politics.
The drug will only be available through a restricted distribution system. The FDA has approved it for patients who have failed to respond adequately to at least two other drugs. Additionally, all patients will be tracked in a registry to monitor long-term safety and effectiveness.
The immediate impact of ketamine is thought to last just four to seven days and there's no consensus yet on how long patients can benefit from ongoing treatment. "This has implications for treatment-resistant patients who have not responded to standard antidepressants, as esketamine potentially offers a better chance at achieving remission than traditional medications". The most effective treatment in such cases, electroshock therapy, requires patients to be fully sedated and can cause persistent memory loss.
A decades-old drug, ketamine is already used off-label to treat depression by some doctors. At least 150 clinics around the US provide treatment with various forms of the drug, which is available as a low-priced generic. It did not, however, reveal the drug's list price.
But he hopes that doctors who are now using ketamine continue to do so.
Approval of the drug, which will be sold by J&J as Spravato, gives a new treatment option for individuals who have previously failed two or more antidepressants, a population that is estimated to account for roughly a third of the 16 million adults in the USA who have had an episode of major depressive disorder.
Although it was approved, the new medication has many risks and is therefore required to be used only under the direct supervision of a physician.
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