FDA Approves Major Novel Depression Drug For First Time In 3 Decades

More than three decades after the launch of Eli Lilly And Co LLY's Prozac, a major new depression drug has been approved with a faster mode of action than existing treatments. 

What Happened

Johnson & Johnson JNJ's Janssen unit announced Tuesday that the FDA approved Spravato — chemically esketamine CIII nasal spray — for use in conjunction with an oral antidepressant in adults with treatment-resistant depression.

A patient is said to be afflicted with treatment-resistant depression if they have tried at least two antidepressants but not benefited from them.

The catch with the FDA approval is that the drug is available only through a certified treatment center that is trained to administer the medicine and address patient needs under a risk evaluation and mitigation strategy, or REMS — a FDA program for monitoring of medications with a high potential for serious adverse effects.

The REMS mandates that the prescriber and patient sign a patient enrollment form stating that the patient understands they should make arrangements to safely leave the health care setting and should not drive or use heavy machinery for the rest of the day after they have been administered the drug.

The Spravato label comes with a boxed warning that relays the risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse and suicidal thoughts and behaviors following the administration of the drug.

Last month, a FDA panel had voted 14-2 in favor of the benefit-risk profile of esketamine.

The wholesale acquisition cost of Spravato is between $590 and $885 per treatment session, or $4,720 to $6,785 for the first month of treatment, which includes two sessions a week, STATNews said, quoting Janssen.

Why It's Important

This is the first time the regulatory body has approved esketamine for any indication, although ketamine, a widely used party drug, has been prescribed off label by doctors for patients who have not responded to existing antidepressants and other treatments. Ketamine was approved in 1970. Esketamine is a S-enantiomer or an optical isomer of ketamine and is more active than the latter.

"Spravato has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies," said Mathai Mammen, global head of Janssen R&D, said in a statement. 

Related Links:

The Daily Biotech Pulse: Horizon Pharma Under DoJ Radar, FDA Greenlights J&J's Depression Drug, Endologix Reverse Split

Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Photo courtesy of Janssen. 

Posted In: STATNewsNewsHealth CareFDATrading IdeasGeneral

Ad Disclosure: The rate information is obtained by Bankrate from the listed institutions. Bankrate cannot guaranty the accuracy or availability of any rates shown above. Institutions may have different rates on their own websites than those posted on Bankrate.com. The listings that appear on this page are from companies from which this website receives compensation, which may impact how, where, and in what order products appear. This table does not include all companies or all available products.

All rates are subject to change without notice and may vary depending on location. These quotes are from banks, thrifts, and credit unions, some of whom have paid for a link to their own Web site where you can find additional information. Those with a paid link are our Advertisers. Those without a paid link are listings we obtain to improve the consumer shopping experience and are not Advertisers. To receive the Bankrate.com rate from an Advertiser, please identify yourself as a Bankrate customer. Bank and thrift deposits are insured by the Federal Deposit Insurance Corp. Credit union deposits are insured by the National Credit Union Administration.

Consumer Satisfaction: Bankrate attempts to verify the accuracy and availability of its Advertisers' terms through its quality assurance process and requires Advertisers to agree to our Terms and Conditions and to adhere to our Quality Control Program. If you believe that you have received an inaccurate quote or are otherwise not satisfied with the services provided to you by the institution you choose, please click here.

Rate collection and criteria: Click here for more information on rate collection and criteria.