Pharma Giant Johnson & Johnson Asks FDA To Approve Esketamine Nasal Spray For Treatment-Resistant Depression
Pharma giant Johnson & Johnson (NYSE:JNJ) announced Monday it had asked the Food and Drug Administration (FDA) to approve its nasal spray as a monotherapy for treatment-resistant depression (TRD) in adults.
The New Jersey-based company’s Spravato, contains esketamine as an active ingredient, which is a nasal spray derivative formulation of a dissociative anesthetic, ketamine. While for years, ketamine has been used as an anesthetic in medical settings, recent clinical trials led to its broader application, most commonly for depression treatment.
FDA approved Spravato in 2019 but only in combination with oral antidepressants; it is available through a restricted program requiring monitoring by healthcare professionals. If the FDA approves the new drug application, this will be the first and only monotherapy for adults with treatment-resistant depression, writes Green Market Report’s Adam Jackson.
Nearly 30% of the estimated 280 million people worldwide living with major depressive disorder have TRD, which …