CHICAGO--(BUSINESS WIRE)--Elorac, Inc., a biopharmaceutical company focused on developing best-in-class, innovative, proprietary drugs, announced that Scott Phillips, M.D., Sr. V.P. Scientific Affairs 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 (“CTCL”) on February 12 at the 4th World Congress of Cutaneous Lymphomas in Barcelona.
SPIRIT-2 is a multi-center, randomized, double-blind, crossover study comparing naloxone lotion 0.5% to its vehicle. CTCL patients with moderate-to-severe pruritus for at least 1-month duration receive either naloxone 0.5% or vehicle daily for a 14-day treatment period (Treatment Period 1), and then following a wash-out period, the alternative study medication for a second 14-day treatment period (Treatment Period 2). 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.
Elorac received Orphan Drug Designation for naloxone lotion from both FDA and the European Medicines Agency (EMA). 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, eligibility for receiving priority review and accelerated approval from FDA. Elorac holds worldwide marketing rights to naloxone lotion.
Naloxone is an opiate antagonist with no agonist activity. Intravenous and subcutaneous formulations of naloxone are used to treat opiate overdoses, and naloxone is used orally in combination with buprenorphine to treat opiate dependence.
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 a doubling of the mortality rate for individuals with CTCL. There are currently no approved therapeutic treatment options for pruritus associated with CTCL.
About Elorac, Inc.
Elorac, Inc. is a privately owned, specialty pharmaceutical company engaged in the development and commercialization of novel products for dermatology, allergy, and oncology. Elorac’s development pipeline candidates include: first in class products for chronic urticaria, atopic dermatitis, psoriasis, acne vulgaris and postherpetic neuralgia.