Elorac's naloxone lotion receives FDA Orphan Drug Designation for pruritus associated with mycosis fungoides

Dec 1 2010

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for its naloxone lotion for the topical treatment of pruritus accompanying cutaneous t-cell lymphoma (CTCL, also known as mycosis fungoides).

“We are very pleased to have received Orphan Drug Designation for naloxone lotion”

Naloxone is an opiate-antagonist with no agonist activity. Intravenous and subcutaneous formulations have been used to treat opiate overdoses, but Elorac's naloxone lotion is unique as the only topical formulation intended to treat the pruritus associated with mycosis fungoides. CTCL, an almost uniformly fatal disorder, affects approximately 18,000 patients in the U.S. During the course of this disease most individuals will experience chronic intractable pruritus unresponsive to standard antipruritic agents (e.g., antihistamines, topical corticosteroids). Chronic intractable pruritus has a significant detrimental impact on quality of life, and for individuals with CTCL, it has been estimated to double the mortality rate compared to those without pruritus.

A Phase II randomized, double-blind clinical trial of naloxone lotion in patients with CTCL demonstrated that naloxone lotion was significantly more effective at relieving pruritus in such patients than vehicle.

"We are very pleased to have received Orphan Drug Designation for naloxone lotion," said Dr. John Kallal, Elorac's Vice President of Medical and Regulatory Affairs. "This approval will provide us with the impetus to aggressively complete the development of this important product."

Dr. Jeffrey Bernstein, Elorac's President and CEO, added, "The development of naloxone lotion for patients with CTCL is consistent with Elorac's philosophy of providing novel therapies for serious dermatologic diseases regardless of the size of the patient population."