Johnson & Johnson could soon have another blockbuster on their hands.
The Food and Drug Administration granted another breakthrough designation to antidepressant esketamine being developed by J&J’s subsidiary Janssen. The new label is to treat major depressive disorder with imminent risk of suicide while the previous label was for treatment-resistant depression assigned in November 2013.
“In the U.S. alone, there are more than 41,000 suicides each year,” Husseini K. Manji, MD, Global Head, Neuroscience Therapeutic Area at Janssen said in a statement, noting some of these cases are a result of untreated or poorly treated depression.
“This designation reinforces the potential of esketamine as a novel treatment for patients with major depressive disorder who are at imminent risk for suicide, a condition for which there currently is no approved treatment and which represents a major public health challenge,” continued Dr. Manji.
Esketamine is an NMDA receptor antagonist, an isomer of the generic anesthetic ketamine, which is used off-label to treat patients with depression. The Janssen drugis administered as an intranasal formulation, which provides faster-acting benefits when compared to the oral treatment alternatives, reported FierceBiotech. The FDA made their decision after reviewing Phase 2 data Janssen presented in May at the Society of Biological Psychiatry conference. The company is currently conducting six ongoing clinical trials for esketamine focusing on treatment-resistant depression.
J&J predicts esketamine could become a blockbuster by bringing in over $1 billion sales, potentially being approved by 2020, wrote FierceBiotech. The drug was on a list of late-stage products J&J released last year with the expectation that they would become a veritable trove of lucrative medications.
Filed Under: Drug Discovery