Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
More than three decades after the launch of Eli Lilly And Co (NYSE:LLY)'s Prozac, a major new depression drug has been approved with a faster mode of action than existing treatments.
What Happened
ENTER TO WIN $500 IN STOCK OR CRYPTO
Enter your email and you'll also get Benzinga's ultimate morning update AND a free $30 gift card and more!
Johnson & Johnson (NYSE: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.
FREE REPORT: How To Learn Options Trading Fast
In this special report, you will learn the four best strategies for trading options, how to stay safe as a complete beginner, a 411% trade case study, PLUS how to access two new potential winning options trades starting today.Claim Your Free Report Here.
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:
Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates
Photo courtesy of Janssen.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.