esreboxetine (AXS-14) / Axsome Therap, Pfizer - LARVOL DELTA

Axsome’s fibromyalgia drug application hits FDA roadblock (Investing.com) - "Axsome Therapeutics, Inc...has encountered a setback as the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter for their New Drug Application (NDA) for AXS-14, intended for fibromyalgia management....The FDA’s preliminary review concluded that the NDA for AXS-14, also known as esreboxetine, did not meet the necessary criteria for a substantive review. The regulatory body specifically pointed out that one of the two placebo-controlled trials included in the submission was not considered adequate and well-controlled due to its 8-week primary endpoint and flexible-dose approach. Conversely, the other trial, which had a 12-week endpoint and used a fixed-dose paradigm, was deemed acceptable....To comply with the FDA’s requirements, Axsome plans to conduct an additional controlled trial with a fixed-dose paradigm and a 12-week primary endpoint. The company expects to initiate this trial in the fourth quarter of 2025."

CRL • New trial • Fibromyalgia

Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Regulatory and Commercial: SYMBRAVO for the acute treatment of migraine, commercial launch (June 2025); AXS-14 for fibromyalgia, FDA filing acceptance decision (2Q 2025); AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025); AXS-12 for narcolepsy, NDA submission (2H 2025)."

FDA filing • Launch • Alzheimer's Disease • Fibromyalgia • Migraine • Narcolepsy

Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated Milestones - Regulatory and Commercial: AXS-14 for fibromyalgia, NDA submission (1Q 2025)....AXS-12 for narcolepsy, NDA submission (2H 2025). Clinical Trial Topline Results: Phase 3 EMERGE trial of AXS-07 in migraine in patients with inadequate response to oral CGRP inhibitors (1Q 2025); Phase 3 FOCUS trial of solriamfetol in ADHD in adults (1Q 2025); Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (1Q 2025); Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026); Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026)."

P3 data: top line • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • Fibromyalgia • Major Depressive Disorder • Migraine • Narcolepsy

Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) for Treatment of Fibromyalgia: A Comprehensive Clinical Review. (PubMed, Psychopharmacol Bull) - "Currently, duloxetine and milnacipran are approved by the Food and Drug Administration although other agents in this drug class including venlafaxine and desvenlafaxine have been studied in the management of fibromyalgia. In addition, selective norepinephrine reuptake inhibitors, esreboxetine and reboxetine, as well as tramadol, a weak opioid mu-receptor agonist with SNRI activity have shown potential utility...Further information is needed to optimize patient selection and dosing regimens as well as elucidate the clinical factors associated with poor response. Moreover, pharmacologic agents may be combined with lifestyle changes and non-drug-based treatments to address the complex interactions of biological and psychosocial factors that facilitate disease development and persistence of symptoms."

Journal • Review • CNS Disorders • Fatigue • Fibromyalgia • Musculoskeletal Diseases • Musculoskeletal Pain • Neuralgia • Pain • Rheumatology

Axsome Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Axsome Therapeutics...Development Pipeline...AXS-14...Fibromyalgia: Manufacturing and other activities related to the planned submission of an NDA for AXS-14 for the management of fibromyalgia are ongoing. The Company expects to submit the NDA in 2023. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the management of fibromyalgia. Solriamfetol...Axsome announced its plans to develop solriamfetol for the treatment of ADHD. The Company anticipates initiating a Phase 2/3 multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of solriamfetol in adults with ADHD in the fourth quarter of this year."

NDA • New P2/3 trial • Attention Deficit Hyperactivity Disorder • CNS Disorders • Fibromyalgia

Organocatalyzed Protecting-Group-Free Total Synthesis of (S,S)- and (S,R)-Reboxetine, an Antidepressant Drug. (PubMed, J Org Chem) - "An efficient, simple, and concise organocatalyzed protecting-group-free synthetic approach to the stereoisomers of the antidepressant drug reboxetine and its implementation toward the asymmetric synthesis of (S,S)-reboxetine and (S,R)-reboxetine from commercially available trans-cinnamaldehyde are described. The synthesis features organocatalytic Jørgensen asymmetric epoxidation, epoxide migration, and Mitsunobu inversion as key steps."

Journal

"$AXSM Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia https://t.co/ARpy4bA4iA" (@stock_titan)

NDA • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Axsome Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update (GlobeNewswire) - "AXS-07: AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine...Axsome is compiling the NDA for AXS-07 for the acute treatment of migraine. Submission of this NDA is expected in early second quarter....Axsome is planning to initiate a Phase 3 trial of AXS-12 in the treatment of narcolepsy in the second quarter. The planned Phase 3 trial will be a randomized, double-blind, placebo-controlled, parallel-group study....Clinical Trial Initiations: Phase 3 trial of AXS-12 in the treatment of narcolepsy (2Q 2021)...FDA Meetings: AXS-14 for fibromyalgia (2Q 2021)."

FDA event • NDA • New P3 trial • CNS Disorders • Fibromyalgia • Migraine • Musculoskeletal Pain • Narcolepsy • Pain • Sleep Disorder

Axsome Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update (GlobeNewswire) - "AXS-14: Axsome is scheduled to meet with the FDA in the first quarter of 2021 to discuss the further clinical development of AXS-14 for the treatment of fibromyalgia. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and a Phase 2 trial in the treatment of fibromyalgia."

FDA event • Fibromyalgia • Musculoskeletal Pain • Pain

Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update (GlobeNewswire) - "AD Agitation:...Axsome remains on track to initiate a second Phase 3 trial of AXS-05 in AD agitation in the second half of 2020....Axsome remains on track to submit an NDA for AXS-07 in the acute treatment of migraine to the FDA in the fourth quarter of 2020. The NDA is supported by positive efficacy results from the MOMENTUM and INTERCEPT trials. Enrollment has been completed in the MOVEMENT...Phase 3 open-label, long-term safety trial...of AXS-07 in the acute treatment of migraine....Anticipated Milestones: NDA Submissions: AXS-07 in the acute treatment of migraine (4Q 2020); FDA Meetings: AXS-05 for AD agitation (2H 2020); AXS-14 for fibromyalgia (2H 2020); Clinical Trial Initiations: Phase 3 trial of AXS-05 in AD agitation (2H 2020)."

Enrollment closed • FDA event • NDA • Trial initiation date • Trial status • Alzheimer's Disease • CNS Disorders • Migraine • Musculoskeletal Pain • Pain