- |||||||||| Spravato (esketamine intranasal) / J&J, Auvelity (bupropion/dextromethorphan) / Axsome Therap
Review, Journal: Glutamatergic Modulators for Major Depression from Theory to Clinical Use. (Pubmed Central) - Oct 17, 2024
Based on this preclinical evidence implicating glutamate in depression and the rapid improvement of depression with ketamine treatment in a proof-of-concept trial, a range of N-methyl-D-aspartate (NMDA)-targeted therapies have been investigated...Nasal administration of esketamine (Spravato
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Journal, HEOR, Real-world evidence, Real-world: Real-world treatment patterns of patients with major depressive disorder treated with auvelity (Pubmed Central) - Aug 4, 2024
A total of 2,254 (10.1%) patients initiated Auvelity without prior treatment in the 12-month pre-index period.Limitations: Incomplete data due to reporting; diagnoses captured subject to coding error; limited generalizability to other populations. Using a large demographically distributed claims database, 22,288 patients with MDD initiated Auvelity within a year of its approval; 10.1% were treatment-na
- |||||||||| Review, Journal: The Black Book of Psychotropic Dosing and Monitoring. (Pubmed Central) - Jul 12, 2024
While acetylcholinesterase inhibitors and memantine have been available for decades, these drugs modestly improve cognition in Alzheimer's disease patients and do not alter the progressive course of the illness...While it remains to be seen how useful these new agents will be in clinical practice, they do represent an approach to treating neuropsychiatric disorders that are a notable departure from the pharmacotherapy of the past half century. It seems likely that some patients who have not been able to respond to or tolerate traditional pharmacotherapy will find hope in these new medications.
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Clinical Profile of AXS-05 in Treating Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_2508;
P2/3, P3
It seems likely that some patients who have not been able to respond to or tolerate traditional pharmacotherapy will find hope in these new medications. AXS-05 demonstrated a substantial , rapid reduction in ADA vs controls after 5 weeks of treatment , increased time-to-relapse vs placebo , and was well - tolerated, supporting its development as a promi sing treatment option for ADA.
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Efficacy and Safety Of AXS-05 in Agitation Associated with Alzheimer (201 ABC (Pennsylvania Convention Center)) - Jun 19, 2024 - Abstract #AAIC2024AAIC_2435;
P3
AXS-05 demonstrated a substantial , rapid reduction in ADA vs controls after 5 weeks of treatment , increased time-to-relapse vs placebo , and was well - tolerated, supporting its development as a promi sing treatment option for ADA. AXS-05 substantially reduced the risk of agitation symptom relapse in participants with AD and was generally well-tolerated in those who achieved sustained clinical response in the OL period.
- |||||||||| Review, Journal: Emerging trends in antipsychotic and antidepressant drug development: Targeting nonmonoamine receptors and innovative mechanisms. (Pubmed Central) - Jun 13, 2024
Additionally, TAK-653 (NBI-1065845) and MJI821 (Onfasprodil) have emerged as potential antidepressants targeting AMPA receptors and NMDA receptor 2B (NR2B) negative allosteric modulation, respectively...By focusing on nonmonoamine receptors and introducing innovative mechanisms, these drugs offer a promising prospect of improved outcomes for individuals suffering from schizophrenia and MDD. Thus, sustained attention and dedication to the development of such drugs are essential to augmenting the therapeutic options available for psychiatric patients.
- |||||||||| lithium carbonate ER / Generic mfg.
Journal: Drugs for depressionr. (Pubmed Central) - Dec 26, 2023
Trial completion date: Jun 2023 --> Dec 2024 | Trial primary completion date: Jun 2023 --> Dec 2024 No abstract available
- |||||||||| Zulresso (brexanolone) / Sage Therapeutics, Spravato (esketamine intranasal) / J&J, Auvelity (bupropion/dextromethorphan) / Axsome Therap
Review, Journal: Pharmacotherapies Targeting GABA-Glutamate Neurotransmission for Treatment-Resistant Depression. (Pubmed Central) - Nov 25, 2023
Of the compounds reviewed here, three are approved by the Food and Drug Administration (FDA): esketamine (Spravato) for TRD, Auvelity (dextromethorphan-bupropion) for major depressive disorder (MDD), and brexanolone (Zulresso) for post-partum depression (PPD). Notably, some concerns have arisen with esketamine and brexanolone, which will be detailed in this study.
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Review, Journal: Dextromethorphan-bupropion (Auvelity) for the Treatment of Major Depressive Disorder. (Pubmed Central) - Oct 20, 2023
In both long-term studies, remission rates approached 70%, while response rates were greater than 80%. These data suggest that dextromethorphan-bupropion is an effective, fast-acting, and well tolerated option for depression treatment and produced remission in a large percentage of patients.
- |||||||||| dextromethadone (REL-1017) / Relmada Therapeutics, Auvelity (bupropion/dextromethorphan) / Axsome Therap
A Review on the Use of NMDA Receptor Antagonist Therapy and Its Potential for Use in Adolescent Treatment-Resistant Depression (Americas Hall II (New York Hilton Midtown); In-person) - Sep 30, 2023 - Abstract #AACAP2023AACAP_943;
This review focuses on NMDAR antagonists dextromethorphan/bupropion (ASX-05) and esmethadone-HCl and their potential for adolescent treatment-resistant depression...A recent phase 3 RCT looking at AXS-05 treatment in 327 adults found an average drop in the MADRS score of 22.2 within 2 weeks of initiation of treatment...With the recent development of lower-potency medications in the NMDAR antagonist class, there appears to already be a safer alternative that could be just as efficacious. Given the better safety profile compared to ketamine, further research should be conducted looking at using these lower-potency NMDAR antagonists in the adolescent population.
- |||||||||| A Comprehensive Review of Novel FDA Approved Psychiatric Indications From 2018-2022 (Hall B Foyer, Exhibition Level Moscone South) - May 17, 2023 - Abstract #APA2023APA_968;
Clinical trials for each medication suggested favorable results in Phase III trials that lead to approval, along with current success in Phase IV trials as well. In 2018, Lucemyra (lofexidine) was approved for the treatment of opioid withdrawal.
- |||||||||| Spravato (esketamine intranasal) / J&J, Auvelity (bupropion/dextromethorphan) / Axsome Therap
Efficacy of Spravato to Auvelity Cross-Titration in MDD (Salon 4) - Apr 15, 2023 - Abstract #ASCP2023ASCP_227;
These fast-acting antidepressants are being used with increasing frequency in the community, and this study proposed seeks to find out more regarding how these therapies fit into the treatment landscape. Learning Objectives Psychopharmacology of novel treatments for depression, Real-world applicability of therapeutics
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Journal: New Combination Drug for Depression. (Pubmed Central) - Mar 25, 2023
Auvelity, an extended-release fixed combination of dextromethorphan and bupropion, is approved for the treatment of major depressive disorder in adults.Like all antidepressants, dextromethorphan-bupropion carries a boxed warning that it may increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Seizures can also occur and are more likely at higher doses.The most common adverse effects of dextromethorphan-bupropion include dizziness, nausea, headache, diarrhea, somnolence, dry mouth, sexual dysfunction, hyperhidrosis, anxiety, constipation, decreased appetite, and insomnia.
- |||||||||| Review, Journal: Novel antidepressant drugs: Beyond monoamine targets. (Pubmed Central) - Feb 27, 2023
The renaissance of psychedelic drugs and the emergence of preliminary positive clinical trial results with psilocybin, Ayahuasca, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), and lysergic acid diethylamide (LSD) may pave the way towards establishing this class of drugs as effective therapies for MDD, TRD and other neuropsychiatric disorders. Going beyond the monoamine targets appears to be an effective strategy to develop novel antidepressant drugs with superior efficacy, safety, and tolerability for the improved treatment of MDD and TRD.
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Journal: Auvelity (dextromethorphan/bupropion). (Pubmed Central) - Feb 2, 2023
Going beyond the monoamine targets appears to be an effective strategy to develop novel antidepressant drugs with superior efficacy, safety, and tolerability for the improved treatment of MDD and TRD. No abstract available
- |||||||||| Review, Journal: Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China. (Pubmed Central) - Dec 3, 2022
The reuse of drugs or combinations currently under investigation for the psychiatric treatment of Alzheimer's disease, including AXS-05, AVP-786, nabilone, brexpiprazole, methylphenidate, and pimavanserin, could provide physicians with additional treatment options. Although most of these drugs have not been explored in China yet, due to the current development trend in this field in China, it is expected that China will be involved in research on these drugs in the future.
- |||||||||| Spravato (esketamine intranasal) / J&J, Auvelity (bupropion/dextromethorphan) / Axsome Therap
Review, Journal: Antidepressants in the post-ketamine Era: Pharmacological approaches targeting the glutamatergic system. (Pubmed Central) - Nov 25, 2022
Clinical trials of agents discovered in the course of these activities are underway, and in 2022, AUVELITY™ (AXS-05; dextromethorphan with bupropion) was approved by the United States Food and Drug Administration. Drug development of post-ketamine agents should provide novel antidepressants that are safer, but as potent and rapidly acting as ketamine.
- |||||||||| bupropion / Generic mfg.
Review, Journal: Dextromethorphan/Bupropion: First Approval. (Pubmed Central) - Nov 16, 2022
Dextromethorphan/bupropion was approved in the USA in August 2022 for the treatment of MDD in adults. This article summarizes the milestones in the development of dextromethorphan/bupropion leading to this first approval for the treatment of adults with MDD.
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Journal: Adjunctive dopaminergic enhancement of esketamine in treatment-resistant depression. (Pubmed Central) - Sep 10, 2022
Recently, AXS-05, an oral combination of dextromethorphan and bupropion, has shown promise in both MDD and TRD clinical trials highlighting the potential validity of this mechanism. This paper describes how dopaminergic enhancement may increase efficacy of esketamine treatment and durability of response encouraging further research into this treatment option.
- |||||||||| Auvelity (bupropion/dextromethorphan) / Axsome Therap
Clinical data, Enrollment closed: ACCORD: Assessing Clinical Outcomes in Alzheimer's Disease Agitation (clinicaltrials.gov) - Aug 26, 2022
P3, N=260, Active, not recruiting,
This paper describes how dopaminergic enhancement may increase efficacy of esketamine treatment and durability of response encouraging further research into this treatment option. Recruiting --> Active, not recruiting
- |||||||||| bupropion/dextromethorphan (AXS-05) / Axsome Therap
Journal: AXS-05: an investigational treatment for Alzheimer's disease-associated agitation. (Pubmed Central) - Jul 31, 2022
Early released clinical trial data indicate that AXS-05 may be a useful option to treat agitation in patients with AD, and that it appears to be generally well tolerated. AXS-05 may be especially helpful for patients with comorbid depression, when considering available data from separate phase III studies assessing the efficacy and safety of this compound in the treatment of depression.
- |||||||||| Review: Investigational Drugs for the Treatment of Depression (Part 2): Glutamatergic, Cholinergic, Sestrin Modulators, and Other Agents. (Pubmed Central) - Jul 20, 2022
Sestrin modulators, cholinergic receptor modulators, or onabotulinumtoxinA have also been investigated for potential antidepressant activity. In conclusion, there is hope for new treatments in uni- and bipolar depression, as it became clear, after almost 7 decades of monoamine-modulating antidepressants, that new pathogenetic pathways should be targeted to increase the response rate in this population.
- |||||||||| Clinical, P2 data, P3 data, Review, Journal: Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry. (Pubmed Central) - Jul 10, 2022
In conclusion, there is hope for new treatments in uni- and bipolar depression, as it became clear, after almost 7 decades of monoamine-modulating antidepressants, that new pathogenetic pathways should be targeted to increase the response rate in this population. These new compounds with novel mechanisms of action are expected to provide a greater variety of treatment options for depression if preliminary positive results are confirmed.
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