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<![CDATA[First Patient Dose in Phase 3 Trial of AXS-14 for Treatment of Fibromyalgia]]>
16 Jan 2026 01:17 GMT
… reboxetine.
Back in June 2025, the US Food and Drug Administration (FDA … of this important investigational medicine for the approximately … , in the completed trials.”2
Fibromyalgia, which is … prevalence and impact, current treatment options remain limited.
…
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Axsome begins Phase III AXS-14 FORWARD trial for fibromyalgia management
16 Jan 2026 10:58 GMT
… initiated the FORWARD Phase III trial evaluating AXS-14 (esreboxetine) for … the SS-enantiomer of racemic reboxetine. AXS-14 remains investigational and … yet approved by the FDA.
Axsome develops treatments targeting central nervous system …
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Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia
15 Jan 2026 12:00 GMT
… multicenter, randomized withdrawal trial in patients with … reboxetine. AXS-14 is an investigational drug product not approved by the FDA … clinical trials and anticipated clinical trials for … . Treatment Patterns Associated with ACR-Recommended Medications in …
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Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy Supporting NDA Submission
31 Dec 2025 11:55 GMT
… narcolepsy. AXS-12 (reboxetine) is a highly selective … efficacy trials, and a completed long-term safety trial. … and Drug Administration (FDA) Orphan Drug Designation for the treatment of … American Academy of Sleep Medicine. The International Classification …
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<![CDATA[Antidepressants Assessed for Reducing Negative Symptoms of Schizophrenia]]>
03 Dec 2025 02:53 GMT
… Medical University, Luzhou, China, and colleagues. "Therefore, incorporating antidepressants into future treatment … , placebo-controlled trials, comprising 655 … escitalopram (n=1), reboxetine (n=3), citalopram … extrapyramidal or sedative drug side effects. …
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Antidepressants Differ Significantly in Cardiometabolic Side Effects
23 Oct 2025 01:36 GMT
… & Drug Administration (FDA) website from … controlled trials (RCTs) comparing antidepressants … , doxepin, levomilnacipran, reboxetine, desvenlafaxine, venlafaxine, and … Antidepressant monotherapy: A claims database analysis of treatment changes and treatment …
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<![CDATA[Antidepressants Differ Significantly in Cardiometabolic Side Effects ]]>
23 Oct 2025 00:52 GMT
… US Food & Drug Administration (FDA) website from database … randomized controlled trials (RCTs) comparing antidepressants and placebo … antidepressants with placebo. RCTs had a median treatment duration … ), phenelzine (n=1), reboxetine (n=5), selegiline (n …
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Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia
09 Jun 2025 11:00 GMT
… this important investigational medicine for the approximately … reboxetine. AXS-14 is an investigational drug product not approved by the FDA … portfolio includes FDA-approved treatments for major … clinical trials and anticipated clinical trials for …
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Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025
11 Jun 2025 11:00 GMT
… Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology … AXS-12 AXS-12 (reboxetine) is a highly … Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of … ongoing clinical trials and anticipated clinical trials for the …
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Axsome plots new fibromyalgia trial after FDA refuses to review former Pfizer candidate
09 Jun 2025 21:05 GMT
… their primary endpoints.
Both trials were conducted by Pfizer. … the FDA’s Division of Anesthesiology, Addiction Medicine and Pain Medicine … to the New York biotech’s first quarter earnings … revitalize reboxetine, called AXS-12 at Axsome, as a treatment for …