naloxone hydrochloride dehydrate lotion (E-0316) / Elorac - LARVOL DELTA

Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL (clinicaltrials.gov) - P3 | N=59 | Terminated | Sponsor: Elorac, Inc. | N=160 ➔ 59 | Trial completion date: Aug 2023 ➔ Sep 2022 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2023 ➔ Sep 2022; Sponsor decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL (clinicaltrials.gov) - P3; N=160; Recruiting; Sponsor: Elorac, Inc.; Trial completion date: Aug 2022 ➔ Aug 2023; Trial primary completion date: Jun 2022 ➔ Jun 2023

Clinical • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Pruritus • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Elorac Biotherapeutics Announces Amendment to Naloxone Lotion Phase III Study For Increased Access to Patients (Businesswire) - "Elorac Biotherapeutics...announced it has amended its current clinical trial evaluating the safety and efficacy of topically applied naloxone hydrochloride lotion, 0.5%, for the treatment of moderate or severe pruritus in patients with the mycosis fungoides or Sézary Syndrome forms of Cutaneous T-cell Lymphoma (CTCL)....'The availability of a topical medication to effectively treat the pruritus of mycosis fungoides and Sezary syndrome will be welcomed by our patients whose itch, in many cases, is inadequately treated by currently available medications, and not only impacts their quality of life but can increase their morbidity and mortality due to infection,' adds Lucia Seminario-Vidal, MD, PhD..."

Clinical protocol • Media quote • Pruritus

Topical Naloxone to Diagnose Ocular Pain (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Seema Capoor; Not yet recruiting ➔ Recruiting

Enrollment open • Dry Eye Disease • Mood Disorders • Neuralgia • Ophthalmology • Optic Neuritis • Pain • Peripheral Neuropathic Pain

Topical treatment with a mu opioid receptor agonist alleviates corneal allodynia and corneal nerve sensitization in mice. (PubMed, Biomed Pharmacother) - "Finally, these DAMGO-induced behavioral and electrophysiological responses were totally blunted by the topical application of naloxone methiodide, an opioid receptor antagonist. Overall, these results provide evidence that topical pharmacological MOR activation may constitute a therapeutic target for the treatment of corneal pain and improve corneal nerve function to alleviate chronic pain."

Journal • Preclinical • Immunology • Inflammation • Keratitis • Ocular Inflammation • Ophthalmology • Pain

Topical Naloxone to Diagnose Ocular Pain (clinicaltrials.gov) - P1; N=10; Not yet recruiting; Sponsor: Seema Capoor

New P1 trial • Dry Eye Disease • Mood Disorders • Neuralgia • Ophthalmology • Pain

Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL (clinicaltrials.gov) - P3; N=160; Recruiting; Sponsor: Elorac, Inc.; Trial completion date: Aug 2021 ➔ Aug 2022; Trial primary completion date: Jun 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Pruritus

Elorac to present naloxone lotion phase III study update at the 4th World Congress of Cutaneous Lymphomas in Barcelona (Businesswire) - P3, N=160; SPIRIT-2 (NCT02811783); Sponsor: Elorac; "Elorac...will present an update of its ongoing Phase III SPIRIT-2 trial evaluating the safety and efficacy of naloxone lotion for relief of pruritus (itching) associated with Cutaneous T-Cell Lymphoma...The study is currently being conducted at 20 sites in the United States and is being expanded to include sites in Europe, Canada, Australia and Asia."

P3 data