On October 6, 2020 Elorac Biotherapeutics, Inc., a biopharmaceutical company focused on developing innovative, best-in-class, proprietary drugs, reported 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) (Press release, Elorac, OCT 6, 2020, View Source [SID1234568165]). The original double-blind, cross-over, multi-center Phase 3 study has been amended to provide access to naloxone lotion to all enrolled subjects for an additional six months after study completion.
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Scott B. Phillips, MD, Elorac’s Sr. V.P. Scientific Affairs, who earlier this year presented an update on this trial at the 4th World Congress of Cutaneous Lymphomas in Barcelona, hosted an industry breakout room on September 12, 2020 as part of the Cutaneous Lymphoma Foundation’s patient conference.
"The availability of naloxone lotion within the current Phase 3 study offers potential relief to people living with cutaneous T-cell lymphoma whose quality of life is significantly impaired by chronic, unrelenting itching," said Susan Thornton, CEO, Cutaneous Lymphoma Foundation.
"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, Associate Director, Clinical Research Unit, Dermatology and Cutaneous Surgery, University of South Florida and Co-director of the Multi-disciplinary Cutaneous Lymphoma Clinic, Moffitt Cancer Center.
Elorac received Orphan Drug Designation for naloxone hydrochloride lotion from both FDA and the European Medicines Agency. Elorac also has Fast Track designation from FDA for this novel investigational new drug. Fast Track designation provides for earlier and more frequent interaction with FDA during a drug’s development and eligibility for receiving priority review and accelerated approval from FDA. Elorac holds worldwide marketing rights to naloxone lotion.
About Naloxone
Naloxone is an opiate antagonist with no agonist activity. Intravenous, subcutaneous, and intranasal formulations of naloxone are used to treat opiate overdoses, and naloxone is used orally in combination with buprenorphine to treat opiate dependence. Naloxone lotion is an investigational new drug designed to relieve pruritus associated with CTCL and is not approved for marketing in the United States.
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL affects approximately 30,000 patients in the United States, with an estimated 3,000 new cases diagnosed each year. During the course of this disease most patients will experience chronic intractable pruritus unresponsive to standard antipruritic agents (e.g., antihistamines and topical corticosteroids). In addition to a very detrimental impact on quality of life, chronic intractable pruritus has been associated with an increase in the mortality rate for individuals with CTCL. There are currently no approved therapeutic treatment options for pruritus associated with CTCL.