Elorac, a specialty pharmaceutical company focused on the treatment of dermatological disorders, has been granted Fast Track designation by the FDA for its 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.
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. Elorac’s naloxone lotion is unique as the only topical formulation intended to treat the pruritus associated with CTCL.
“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, president and CEO of Elorac. “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, vice president of medical affairs, Elorac, 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 III 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.