Janssen Announces U.S. FDA Approval of SPRAVATO ® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior

TITUSVILLE, N.J. – (August 3, 2020) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation orbehavior.1 SPRAVATO® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,1 providing a new option for significant symptom relief until a longer-term, comprehensive treatment plan can take effect. The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. SPRAVATO® carries a Boxed Warning regarding a Risk Evaluation and Mitigation Strategy (REMS) and the risk of suicidal thoughts and behaviors. See below for Important Safety Information. SPRAVATO® will be made available at REMS certified treatment centers. Janssen is working to responsibly educate and certify treatment centers in accordance with the REMS so healthcare providers can offer SPRAVATO® to appropriate patients.Click to Tweet: #BREAKINGNEWS: FDA approves a new indication for @JanssenUS medicin...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Publication date: Available online 26 September 2020Source: Brain StimulationAuthor(s): Sachin Pradeep Baliga, Urvakhsh Meherwan Mehta, Shalini S. Naik, Milind Vijay Thanki, Sayantanava Mitra, Shyam Sundar Arumugham, Muralidharan Kesavan, Jagadisha Thirthalli
Source: Brain Stimulation - Category: Neurology Source Type: research
CONCLUSIONS: This study presents a way to manage patients who refuse blood transfusions while undergoing orthognathic surgery. rEPO and iron supplementation were used to maintain Hb levels above 10 g/dL. During surgery, blood loss was minimized by a meticulous procedure and induced hypotensive anesthesia, and intravascular volume was maintained by ANH. Our practical approach to orthognathic surgery for Jehovah's Witnesses can be applied to the management of all patients who refuse blood transfusions. PMID: 32971591 [PubMed]
Source: Archives of Plastic Surgery - Category: Cosmetic Surgery Tags: Arch Plast Surg Source Type: research
CONCLUSIONS: The surgical outcomes of arterial free flaps were superior to those of venous free flaps for volar defects of the PIP joint. PMID: 32971597 [PubMed]
Source: Archives of Plastic Surgery - Category: Cosmetic Surgery Tags: Arch Plast Surg Source Type: research
CONCLUSIONS: The reported average duration for conventional subcutaneous TE expansion is 79.4 days, but this pilot study using the Blossom system achieved an average expansion duration of less than 14 days in both groups. The Blossom system may accommodate single-stage breast reconstruction. The overall complication rate of this study was 4.5%, which is promising compared to the reported complication rates of two-stage breast reconstruction with TEs (20%-45%). PMID: 32971593 [PubMed]
Source: Archives of Plastic Surgery - Category: Cosmetic Surgery Tags: Arch Plast Surg Source Type: research
This study investigated the associations of intraoperative blood loss and surgical time with the direction of maxillary movement. METHODS: This retrospective study involved patients who underwent OGS from October 2017 to February 2020. They were classified based on whether maxillary setback was performed into groups A1 and B1, respectively. Relative blood loss (RBL, %) was used as an indicator to compare intraoperative blood loss between the two groups. The surgical time of the two groups was also measured. Subsequently, the patients were reclassified based on whether posterior impaction of the maxilla was performed in...
Source: Archives of Plastic Surgery - Category: Cosmetic Surgery Tags: Arch Plast Surg Source Type: research
Abstract Inhaled pulmonary vasodilators are a powerful tool in the arsenal of therapies designed to treat pulmonary hypertension in pediatrics. Yet only 1 inhaled vasodilator, inhaled nitric oxide (INO), has been approved by the Food and Drug Administration for use in neonates> 34 weeks gestational age with persistent pulmonary hypertension of the newborn. Off-label use of inhaled vasodilators is common in the neonatal and pediatric population despite a lack of evidence. Growing focus on providing evidence-based therapies combined with the increasing cost of INO has led to the exploration of other inhaled pulmo...
Source: Respiratory Care - Category: Respiratory Medicine Authors: Tags: Respir Care Source Type: research
Conclusion: Gluteal compartment syndrome is a surgical emergency that must be considered postoperatively especially in obese patients with prolonged operation times who experience acute buttock pain. The use of positional bars or "bumps" in the gluteal area should be used with caution and raise awareness of this complication after orthopedic surgeries. PMID: 32973924 [PubMed]
Source: Patient Safety in Surgery - Category: Surgery Authors: Tags: Patient Saf Surg Source Type: research
CONCLUSION: The results of this study suggest that the severity of SCI greatly affects language ability. In children with severe SCI, social communication and social motivation negatively predicted receptive language and expressive language, respectively. Children with severe RRB may have more emotional-behavioral problems that require active intervention. PMID: 32975063 [PubMed - in process]
Source: Yonsei Medical Journal - Category: Universities & Medical Training Authors: Tags: Yonsei Med J Source Type: research
Abstract PURPOSE: Non-alcoholic fatty liver disease (NAFLD) is independently associated with the development of atrial fibrillation (AF). However, the association of AF with advanced liver fibrosis, which is related to all-cause, cardiovascular, and liver-related mortality, has not been established in NAFLD patients. We aimed to investigate the association between AF and advanced liver fibrosis in NAFLD patients. MATERIALS AND METHODS: Out of 53704 adults who participated in the health check-up program, 6293 subjects aged 35 years and older were diagnosed as NAFLD using ultrasound. The stage of liver fibrosis...
Source: Yonsei Medical Journal - Category: Universities & Medical Training Authors: Tags: Yonsei Med J Source Type: research
Abstract PURPOSE: Thrombocytopenia (platelet count
Source: Yonsei Medical Journal - Category: Universities & Medical Training Authors: Tags: Yonsei Med J Source Type: research
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