FDA grants Fast Track designation to Elorac's naloxone topical lotion

Apr 15 2013

Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's naloxone topical lotion for the relief of pruritus in patients with cutaneous T-cell lymphoma (CTCL). There are currently no approved therapeutic treatment options available to patients and their physicians for pruritus in CTCL.

“Fast Track designation will help us to actively complete the development of this important new drug. We look forward to finalizing the design of, and then initiating, the Phase 3 pivotal program as soon as possible.”

FDA describes Fast Track as "a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier." Fast Track designation offers the opportunity for earlier and more frequent interaction with FDA during a drug's development, as well as a greater likelihood of receiving priority review from FDA.

"We are very pleased that naloxone lotion has been awarded Fast Track designation. The FDA's decision reflects the seriousness of pruritus associated with CTCL and the unmet medical need faced by patients suffering from this condition," said Dr. Jeffrey Bernstein, Elorac's President and Chief Executive Officer. "We are excited about the prospect of expediting clinical development and speeding the time to market for naloxone lotion, as a result of Fast Track designation."

Dr. John Kallal, Elorac's Vice President of Medical Affairs added, "Fast Track designation will help us to actively complete the development of this important new drug. We look forward to finalizing the design of, and then initiating, the Phase 3 pivotal program as soon as possible."

Elorac previously received Orphan Drug Designation for naloxone lotion from both FDA and the European Medicines Agency. Elorac holds worldwide marketing rights to naloxone lotion.