CHICAGO--()--Elorac, Inc., a rapidly growing specialty pharmaceutical company focused on the treatment of dermatological disorders, announced that the European Medicines Agency (EMA) has designated Naloxone hydrochloride dehydrate as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council.
“We are gratified that pruritus associated with CTCL has been recognized as an important unmet medical need, and we are very excited about the prospect of commencing our Phase III clinical program next year.”
Naloxone hydrochloride dehydrate is designated as an orphan medicinal product for the indication: Treatment of cutaneous T-cell lymphoma (CTCL). This designation, which was granted to Elorac’s European subsidiary, is entered in the Community Register of Orphan Medicinal Products under the number EU/3/12/1057.
Orphan designation in the European Union (EU) provides a range of incentives, including reduced fees for regulatory activities and ten years of market exclusivity once an orphan medicine is approved.
In 2010, Elorac received orphan drug designation from the U.S. Food and Drug Administration for its naloxone lotion for the topical treatment of pruritus accompanying mycosis fungoides, the most common type of CTCL.
A Phase II randomized, double-blind clinical trial of naloxone lotion in patients with CTCL demonstrated that naloxone lotion was significantly more effective than vehicle at relieving pruritus associated with the disease.
Naloxone lotion is an investigational new drug being developed by Elorac; the product has not been approved for commercial sale anywhere in the world.
Naloxone is an opiate-antagonist with no agonist activity. Intravenous and subcutaneous formulations have been used to treat opiate overdoses, and naloxone has been used orally in combination with buprenorphine to treat opioid dependence, but Elorac’s naloxone lotion is unique as the only topical formulation intended to treat the pruritus associated with CTCL. CTCL, an almost uniformly fatal disorder, affects approximately 18,000 patients in the United States and an estimated 28,000 patients in the EU. During the course of this disease most individuals will experience chronic intractable pruritus unresponsive to standard antipruritic agents (e.g., antihistamines and 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.
“We are very pleased to have received orphan designation for naloxone lotion in Europe,” said Dr. John Kallal, Elorac’s Vice President of Medical and Regulatory Affairs. “We are gratified that pruritus associated with CTCL has been recognized as an important unmet medical need, and we are very excited about the prospect of commencing our Phase III clinical program next year.”
Dr. Jeffrey Bernstein, Elorac’s President and CEO, added, “The European orphan drug designation provides us with additional proprietary protection for naloxone lotion as we expand our efforts internationally.”
About Elorac, Inc.
Elorac, Inc., based in Vernon Hills, IL, is a specialty pharmaceutical company engaged in the development and commercialization of novel prescription products for the advancement of skin care. By leveraging the extensive development and commercialization capabilities of its experienced management team, Elorac develops and commercializes unique prescription products with potentially significant improvements over current therapies in dermatology.
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