FDA Approves Nasal Spray Depression Treatment Spravato Based On Club Drug Ketamine

Leslie Hanson
Марта 12, 2019

Advocates for anti-depression therapies are applauding federal regulators for approving the first new treatment for depression in decades - a medication derived from a notorious party drug.

"This is going to bring in some standards, regulation and it's going to make it safer and more accessible to patients", said Levine, who serves as vice president of the American Society of Ketamine Physicians, a group representing doctors, nurses and others using ketamine for treating depression or other nonapproved uses.

The US Food and Drug Administration has approved esketamine to treat adults whose depression hasn't responded to other antidepressants, the agency announced in a statement yesterday (March 5). It's one of several psychedelic drugs that are being reconsidered for depression.

Some researchers contend that esketamine needs more study and additional clinical trials.

The anti-depressant Spravato comes in the form of a nasal spray from Johnson & Johnson that will be paired with an oral medication.

Esketamine works on the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor in the brain.

This photo provided by Janssen Global Services shows Spravato nasal spray.

The FDA has more about this approval. Dr. Sanacora was an investigator on some of J&J's clinical trials of Spravato.

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Esketamine, developed by Johnson & Johnson, will be administered as a nasal spray and be used in conjunction with an oral antidepressant.

Two of the other three short-term trials did not meet pre-determined statistical tests for effectiveness.

UCLA's Dunn noted the maintenance study gave the FDA a chance to assess Spravato's longer-term effects, which have been less well-documented in previous studies of ketamine. They also said they believed esketamine's benefits outweighed its risks.

"For those people for whom it does work, it could be life-saving and life-changing", he added. Of 17 members, 14 voted in favor of recommending approval, two voted against, and one abstained.

Due to the high potential risk of misuse of the drug, Spravato will only be available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS). Patients are required to sign a form attesting that they understand they need to make arrangements to safely get home and that they can not drive or use heavy machinery on the day they receive the drug.

"We really don't know the long-term safety of this drug", Witczak said in an interview with BioPharma Dive.

The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates. That means twice-weekly treatments during the first month will cost centers that offer the drug at least $4,720 to $6,785.

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