Janssen Seeks Expanded Use of SPRAVATO Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent
January 15, 2020 at 12:40 pm
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Johnson & Johnson announced the submission of a Type II Variation Application to the European Medicines Agency (EMA) for SPRAVATO(esketamine) nasal spray. The application seeks to expand the use of esketamine nasal spray, beyond its current indication, as an acute short-term treatment, co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms in adults with a moderate-to-severe depressive episode of major depressive disorder (MDD) who have current suicidal ideation with intent. The submission is based on results from two double-blind, randomised, placebo-controlled multicentre Phase 3 clinical studies (ASPIRE I & II), which evaluated both the efficacy and safety of esketamine nasal sprayversus a placebo nasal spray when used in addition to comprehensive standard of care (SOC). In these studies, SOC included initial hospitalisation and newly initiated and/or optimised antidepressant therapy, enhanced with extensive twice-weekly visits during the double-blind phase. In both ASPIRE I & II, esketamine nasal spray combined with comprehensive SOC was associated with a reduction in depressive symptoms, and demonstrated clinically meaningful and statistically significant superiority over a placebo nasal spray plus comprehensive SOC in rapidly reducing symptoms of MDD at 24 hours after the first dose. The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as 4 hours after the first dose.
Johnson & Johnson is one of the world's leading producers of healthcare products. Net sales break down by family of products as follows:
- pharmaceutical products (55.4%): drugs intended for the treatment of cardiovascular diseases, oncological diseases, gastro-intestinal illnesses, infectious, immunological, neurological, dermatological diseases, etc.;
- medical products and equipment (28.9%): diagnostic systems, orthopedic and gynecological equipment, surgical materials, etc. for use by healthcare professionals;
- consumer health products (15.7%): OTC drugs (Tylenol, Sudafed, Benadryl, Zyrtec, Motrin, Nicorette and other brands), health and beauty products (Aveeno, Clean & Clear, Dr. CI:Labo, Neutrogena and OGX), baby care products (Johnson's and Aveeno Baby), oral care products (Listerine), feminine hygiene products (Stayfree and Carefree and o.b.), wound care products (Band-Aid and Neosporin) etc.
At the end of 2022, Johnson & Johnson has 89 manufacturing facilities located in the United States (28), North America (9), Europe (27), Africa and Asia/Pacific (25).
Net sales are distributed geographically as follows: the United States (51.2%), Europe (24.7%), Asia/Pacific and Africa (17.7%) and other (6.4%).
Janssen Seeks Expanded Use of SPRAVATO Nasal Spray in Europe as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent