TITUSVILLE, N.J., July 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO® (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD). Nearly 30 percent of the estimated 280 million people worldwide living with major depressive disorder (MDD) have TRD,1 which occurs when there is an inadequate response to two or more oral antidepressants during the same depressive episode.
MUNSTER, IN / ACCESSWIRE / June 12, 2024 / OptiMed HealthCare Partners is pleased to announce the opening of its new center in Munster, Indiana. SPRAVATO® is the first FDA-approved nasal spray for treatment-resistant depression (TRD). OptiMed is proud to lead the change in mental health care by expanding this treatment to Munster, IN.
Comments: Innovative Medicine sales were up 1% to $13.6 billion in the quarter. DARZALEX (daratumumab) sales were $2.7 billion, up 19%. ERLEADA (apalutamide) sales were $689 million, up 27%. CARVYKTI (ciltacabtagene autoleucel) sales were $157 million, up from $72 million in 1Q23. TECVAYLI (teclistamab-cqyv) sales were $133 million, up from 63 million in 1Q23. Other Oncology sales were $178 million, up 80% in the quarter. UPTRAVI (selexipag) sales were up 29% to $468 million and OPSUMIT (macitentan) sales were up 19% to $524 million. TREMFYA (guselkumab) sales were up 26% to $808 million. SPRAVATO (esketamine) sales were up 72% to $225 million. COVID-19 Vaccine sales were down 97% to $25 million. XARELTO sales were down 10% to $518 million. REMICADE sales were down 11% to $434 million. ZYTIGA sales were down 26% to $181 million. CONCERTA sales were down 14% to $177 million.
BEERSE, BELGIUM, 8 October 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced further findings for SPRAVATO® (esketamine nasal spray [NS]) from the ESCAPE-TRD study. Data on treatment-emergent adverse events (TEAEs) suggest a more favourable tolerability profile in adults with treatment-resistant major depressive disorder (TRD) receiving esketamine NS than quetiapine XR. Across all reported TEAEs experienced with esketamine NS, 92.1 percent were transient and resolved the same-day vs 12.1 percent of TEAEs experienced with quetiapine XR.1 The findings were presented at the 36th European College of Neuropsychopharmacology Congress (ECNP 2023) taking place from 7 October to 10 October in Barcelona, Spain.
FDA Confirms Paragraph IV Patent Litigation for Esketamine Hydrochloride
(Yicai Global) April 21 -- China has given the green light to the local unit of Janssen Pharmaceuticals, owned by US medical device and drug developer Johnson & Johnson, to market its new antidepressant in the country.
New Data from the Phase 3b ESCAPE-TRD Study Show that Participants Receiving SPRAVATO®▼(Esketamine Nasal Spray [NS]) Achieved Higher Response and Remission Rates, Increasing Over Time, Compared to those Receiving Quetiapine Extended-Release
Janssen’s SPRAVATO® (esketamine nasal spray [NS]) helped more participants with treatment-resistant major depressive disorder (TRD) remain remission and relapse free compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), in a Phase III trial (04338321).
The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that the Phase IIIb ESCAPE-TRD clinical trial of Spravato (esketamine nasal spray [NS]) for treatment-resistant major depressive disorder (TRD) in adult patients met its primary endpoint.
Johnson & Johnson’s esketamine nasal spray continues to build a body of evidence showing it can go toe-to-toe with tough-to-treat depression.