Elyxyb (celecoxib) / Dr. Reddy’s, Collegium Pharma, Sorrento - LARVOL DELTA

Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Oncology • Oral Cancer

Scilex Holding Company Announces Approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB’s Acute Treatment of Migraine With or Without Aura in Canada (GlobeNewswire) - "Scilex Holding Company...today announced that it has received approval of a New Drug Submission (NDS) from the Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for ELYXYB’s acute treatment of migraine with or without aura in Canada."

Canada approval • Migraine

Scilex Holding Company Announces that the U.S. FDA Has Acknowledged the Submission of Our Supplemental New Drug Application for ELYXYB in Acute Pain Indication (GlobeNewswire) - "Scilex Holding Company...today announced that the U.S. FDA has acknowledged the submission of our Supplemental New Drug Application (SNDA) for ELYXYB in acute pain indication."

FDA filing • Pain

Scilex Holding Company Announces that It Will Be Filing Today of a Supplemental New Drug Application with the FDA for ELYXYB in Acute Pain Indication (GlobeNewswire) - "Scilex Holding Company...announced that it will be filing today of a Supplemental New Drug Application (SNDA) with the FDA for ELYXYB in acute pain indication. The analgesic efficacy and safety of ELYXYB, a new oral liquid formulation of celecoxib with more rapid absorption than the capsule, were evaluated in the treatment of acute pain in adult patients after dental surgery."

FDA filing • Pain

Efficacy of celecoxib oral solution in participants with insufficient response to triptans for the acute treatment of migraine: pooled results from a post-hoc analysis of 2 phase 3 randomized clinical trials (PAINWeek 2024) - P3 | "Background: Many patients with migraine who receive a prescription for sumatriptan or another serotonin 5-HT1B/1D receptor agonist (triptan) experience inadequate efficacy, relapse within 24 hours after the first dose, or treatment-emergent adverse events. Demographics were similar among triptan insufficient responders and responders (Table). Among triptan insufficient responders, celecoxib 120 mg oral solution was more effective than placebo for 2-hour pain freedom (33.3% [33/99] vs 14.3% [12/84]), and the odds of achieving pain freedom were 200% greater with celecoxib 120 mg oral solution than with placebo (OR=3.0, p=0.0036). Among triptan responders, rates of 2-hour pain freedom were also higher for celecoxib 120 mg oral solution than for placebo (33.3% [13/39] vs 14.6% [6/41]), and the odds of achieving 2-hour pain freedom was 192% greater with celecoxib 120 mg oral solution than with placebo (OR=2.92, p=0.0548); the difference between the groups was..."

Clinical • P3 data • Retrospective data • CNS Disorders • Migraine • Pain

Scilex Holding Company Announces the U.S. Patent and Trademark Office Will Be Issuing New ELYXYB Patent Related to the Treatment of Acute Pain (Yahoo Finance) - "Scilex Holding Company...today announced that the U.S. Patent and Trademark Office has allowed numerous claims from U.S. patent application no. 17/562,229 and will issue a new patent containing those claims related to the treatment of acute pain (the “Patent”), to Scilex in late 2024, further strengthening the Company’s intellectual property position and coverage for its acute migraine treatment drug product, ELYXYB, a liquid, micro-encapsulation formulation of celecoxib. The Patent, titled 'Methods of Treating Pain,' covers methods of treating acute pain."

Patent • CNS Disorders • Migraine • Pain

Pain freedom with celecoxib oral solution, ubrogepant, and rimegepant through 4 hours postdose: Post hoc analysis in the acute treatment of migraine (AHS 2024) - "Participants who were treated with celecoxib 120 mg oral solution achieved higher pain-free therapeutic gains than those who were treated with ubrogepant 100 mg or rimegepant 75 mg from 60 min through 3 h postdose. To achieve pain freedom with celecoxib oral solution, fewer patients may need to be treated, and they may have less likelihood of being harmed than with ubrogepant 100 mg or rimegepant 75 mg."

Retrospective data • CNS Disorders • Migraine • Pain

Efficacy of celecoxib oral solution in participants with insufficient response to triptans for the acute treatment of migraine: pooled results from a post hoc analysis of 2 phase 3 randomized clinical trials (AHS 2024) - P3 | "Background: Many patients with migraine who receive a prescription for sumatriptan or another serotonin 5-HT1B/1D receptor agonist (triptan) experience inadequate efficacy, relapse within 24 h after the first dose, or treatment-emergent adverse events. Participants treated with celecoxib oral solution 120 mg were more likely than those treated with placebo to achieve pain freedom at 2 h postdose regardless of their historical response to triptans. TABLE 1 Demographics of the triptan insufficient responder and triptan responder subgroups. FIGURE 1 Efficacy of celecoxib oral solution 120 mg in triptan insufficient responders and triptan responders."

Clinical • P3 data • Retrospective data • CNS Disorders • Migraine • Pain

Scilex Holding Company to Present Poster on ELYXYB (celecoxib oral solution) at the 66th Annual Scientific Meeting of the American Headache Society (AHS) to be Held in San Diego, CA on June 13-16, 2024 (GlobeNewswire) - "Scilex Holding Company...today announced it will be presenting a poster on ELYXYB...at the 66th Annual Scientific Meeting of the American Headache Society (AHS) to be held in San Diego, CA on June 13-16, 2024....The poster presentation will describe...pooled results from a post hoc analysis of two Phase 3 randomized clinical trials. Key highlights of the ELYXYB (celecoxib oral solution) presentation: Efficacy of celecoxib oral solution in participants with insufficient response to triptans for the acute treatment of migraine: pooled results from a post-hoc analysis of two Phase 3 randomized clinical trials. In a post-hoc analysis of two Phase 3 randomized clinical trials, the efficacy of ELYXYB was compared with placebo in patients who were previously treated with triptans."

P3 data • Retrospective data • CNS Disorders • Migraine • Pain

Scilex Holding Company Announces Launching of Co-Pay Programs for Both ZTlido and ELYXYB for Commercially Insured Patients and the addition of ELYXYB to a Multi-State Medicaid Pharmaceutical Purchasing Group to Its Purchasing Pool (Yahoo Finance) - "Scilex Holding Company...today announced launching of co-pay programs for both ZTlido and ELYXYB with the out-of-pocket costs for its product portfolio for commercially insured patients capped at $25 monthly, with certain eligible patients paying as low as $0. This applies to the Company's postherpetic neuralgia pain product, ZTlido, and migraine product, ELYXYB....Additionally, on April 1, 2024, a multi-state Medicaid pharmaceutical purchasing group added ELYXYB to its purchasing pool to make it eligible for thirteen States’ Medicaid programs."

Medicaid • Reimbursement • CNS Disorders • Migraine • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex Holding Company Announces New Out-of-Pocket Costs for Commercially Insured Patients (GlobeNewswire) - "Scilex Holding Company...today announced that the out-of-pocket costs for its product portfolio for commercially insured patients is expected to be capped at $25 monthly, with certain eligible patients paying as low as $0. This applies to the Company's postherpetic neuralgia pain product, ZTlido, migraine product, ELYXYB....Scilex has made significant investments to improve patient affordability and access to its products and continues to build on the Company's commitment to provide non-opioid pain management products to patients."

Reimbursement • CNS Disorders • Migraine • Neuralgia • Pain • Peripheral Neuropathic Pain

Scilex advances ELYXYB migraine treatment in Canada (Investing.com) - "Scilex Holding Company...has recently made progress with the Canadian regulatory process for its migraine medication, ELYXYB. The company responded to Health Canada's Office of Patented Medicines and Liaison (OPML) inquiries regarding the product composition in ELYXYB's patent, as part of its New Drug Submission (NDS) review by Health Canada's Pharmaceutical Drugs Directorate....The NDS for ELYXYB was filed in December 2023, and the approval process in Canada is expected to take approximately 12 months, subject to review cycles and additional information requests by Health Canada."

Canadian regulatory • CNS Disorders • Migraine • Pain

Scilex Holding Company Provides Responses to Product Composition Questions Related to its ELYXYB Patent in Canada for a New Drug Submission Under Review by Health Canada for the Approval of ELYXYB for Acute Treatment of Migraine With or Without Aura in Canada (GlobeNewswire) - "Scilex Holding Company...announced that it has responded to questions on the product composition in the ELYXYB patent from Health Canada’s Office of Patented Medicines and Liaison (OPML) during review of a New Drug Submission ('NDS') to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of ELYXYB for acute treatment of migraine with or without aura in Canada."

Canadian regulatory • CNS Disorders • Migraine

Scilex Holding Company Announces Filing of a New Drug Submission (NDS) to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the Approval of ELYXYB for Acute Treatment of Migraine With or Without Aura in Canada (Yahoo Finance) - "Scilex Holding Company...today announced that it has filed a New Drug Submission (NDS) to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of ELYXYB® for acute treatment of migraine with or without aura in Canada."

Canadian regulatory • CNS Disorders • Migraine • Pain

Scilex Holding Company announces major pharmacy initiative with the national leading pharmacy chain to stock ELYXYB in most of their stores throughout the U.S. (Yahoo Finance) - "Scilex Holding Company...today announced a national leading pharmacy chain to stock ELYXYB®. Previously, Scilex Holding Company announced pharmacy initiative to stock ELYXYB® for the other leading pharmacy chain in the U.S. Scilex is also in the process of negotiating similar potential stocking arrangements with additional pharmacy chains in the U.S."

Commercial • CNS Disorders • Migraine • Pain

Scilex Holding Company Announces Expanded Access to ELYXYB By the Execution of First ELYXYB Insurance Coverage Agreement with One of the Top Three National PBMs (Pharmacy Benefit Manager) for its Medicare Population (Yahoo Finance) - "Scilex Holding Company...announced that it has signed an insurance coverage agreement for ELYXYB^® with a national PBM, for their Medicare population potentially expanding coverage of ELYXYB^®."

Reimbursement • CNS Disorders • Migraine • Pain

Scilex Holding Company announces pharmacy initiative to stock ELYXYB in over 500 stores for a leading pharmacy chain in the U.S. (GlobeNewswire) - "Scilex Holding Company...announced that it has entered into an agreement with a leading pharmacy chain in the U.S. to stock ELYXYB^® in over 500 stores which do not currently stock ELYXYB^®. Scilex is also in the process of negotiating similar potential stocking arrangements with other major pharmacy chains in the U.S."

Commercial • CNS Disorders • Migraine • Pain

Scilex Holding Company Announces Production Increase, Product Availability, and The Brand Marketed and Distributed Under Scilex Pharmaceuticals, Inc. for ELYXYB (Yahoo Finance) - "Scilex Holding Company...today announced the increase of ELYXYB (celecoxib oral solution) manufacturing to meet its rising demand for ELYXYB and increased stocking needs in its distribution center. Scilex has met another significant corporate objective and produced our first commercial batch with Scilex labeled ELYXYB which will enable the Company to meet the growing demands of future customers seeking a rapid onset pain management regimen for the acute treatment of migraine."

Commercial • CNS Disorders • Migraine • Pain

Scilex Holding Company announces the State of Indiana Medicaid will add Elyxyb as a preferred agent to its preferred drug list (PDL) effective October 1, 2023 (GlobeNewswire) - "Scilex Holding Company...announced the State of Indiana Medicaid will add Elyxyb as a preferred agent to its Preferred Drug List ('PDL') effective October 1, 2023....Under the new terms, Elyxyb will be Preferred with the following prior authorization (PA) criteria: Migraine Dx, 18 & Older; Trial and failure of 1 preferred triptan or contraindication to triptans; Elyxyb will have a QL of 6 bottles."

US reimbursement • CNS Disorders • Migraine • Pain

Scilex Holding Company Presented Oral and Poster Presentations on Elyxyb at the 2023 Annual Brain Week Conference Held in Las Vegas, NV (GlobeNewswire) - "Scilex Holding Company...announced that it presented oral and poster presentations at the 2023 Annual Brain Week Conference on the benefits of Elyxyb (celecoxib oral solution). The conference was held from September 6-8, 2023 in Las Vegas, NV....In a post hoc analysis, Elyxyb demonstrated higher pain freedom rates from 60 mins through 3 hours post dose compared to ubrogepant 100 mg and Rimegepant 75 mg. Additionally, Number Needed to Treat (NNT) was lower while Number Needed to Harm (NNH) was higher with Elyxyb than ubrogepant and rimegepant. Taken together, these data suggest that to achieve pain freedom with Elyxyb, fewer patients need to be treated and may have less likelihood of being harmed, than with ubrogepant or rimegepant."

Clinical data • Retrospective data • CNS Disorders • Migraine • Pain

ELYXYB: A Fast Acting, Oral Solution for Acute Migraine* (AHS 2023) - "Sponsored By: Scilex Holding Company Discover the only liquid solution designed to deliver fast and long-lasting migraine relief with the proven safety of COX-2 selectivity. Not Eligible for CME Credits Industry-Sponsored Session (Scilex)"

CNS Disorders • Migraine • Pain

Scilex Holding Company to Present Data on ELYXYB (celecoxib oral solution) at the 65th Annual Scientific Meeting of the American Headache Society, in Austin, TX. (Yahoo Finance) - "Scilex Holding Company...announced that it will be presenting data on ELYXYB™ (celecoxib oral solution) for acute treatment of migraine with or without aura in adults at the 65th Annual Scientific Meeting of American Headache Society (AHS) to be held on June 14-18, 2023 in Austin, Texas....Stuart J. Tepper, MD, FAHS from Dartmouth-Hitchcock Medical Center will be presenting clinical trial data from the ELYXYB pivotal studies."

Clinical data • CNS Disorders • Migraine • Pain

Drugs for migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Consistency of Response to Liquid Celecoxib in Adults With Migraine: Post Hoc Analysis of Results From Two Randomized, Placebo-Controlled Studies (AAN 2023) - "Background Celecoxib oral solution (Elyxyb) is an oral liquid formulation of the cyclooxygenase-2 (COX-2)–selective nonsteroidal anti-inflammatory drug indicated for the acute treatment of migraine in adults. Rates of consistent endpoint achievement at 2 hours postdose between COS and placebo across pain freedom, MBS freedom, and pain relief were, respectively, 18% vs 11%, p=0.016; 40% vs 32%, p=0.033; and 54% vs 45%, p=0.012. Conclusions Across 2 attacks, consistent response to COS was higher than consistent response to placebo for pain freedom, freedom from the MBS, and pain relief at 2 hours postdose."

Clinical • Retrospective data • CNS Disorders • Migraine • Pain

Treatment Effects of Celecoxib Oral Solution in Migraine With Aura and Without Aura: Post-Hoc Analysis of Results From Two Randomized, Double-Blind Placebo-Controlled Trials (AAN 2023) - "Conclusions Pooled data from 2 randomized, double-blind, placebo-controlled trials indicate that celecoxib oral solution 120 mg was more effective than placebo whether subjects treating attacks in trial had a history of aura or not. Interaction models suggest that the magnitude of the treatment effect relative to placebo did not differ by aura status."

Clinical • Retrospective data • CNS Disorders • Migraine • Pain