FAIRFIELD, N.J., Sept. 18, 2020 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. today announced that the Company received a Type C Meeting Written Response from the U.S. Food and Drug Administration (FDA) regarding MM36 (difamilast) for the topical treatment of mild to moderate atopic dermatitis (AD). Based upon the FDA response, Medimetriks is preparing to conduct a single pivotal trial in the U.S. for MM36's New Drug Application (NDA), which will be supported by data from already-completed Phase 3 trials conducted in Japan.
Medimetriks Pharmaceuticals, Inc. today announced that its partner, Otsuka Pharmaceuticals Co. Ltd., achieved positive results in two Phase 3 Japanese clinical trials in adult and pediatric patients for MM36 (difamilast), a novel topical, non-steroidal phosphodiesterase IV (PDE4) inhibitor for the treatment of mild to moderate atopic dermatitis.
Medimetriks Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ozenoxacin cream, 1%, a novel, non-fluorinated quinolone for the treatment of impetigo. Medimetriks licensed exclusive U.S. commercialization rights to ozenoxacin from Ferrer, a leading, privately held Spanish pharmaceutical company, in March 2014 and announced the completion of the second successful Phase 3 pivotal trial in July 2015.
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Medimetriks Pharmaceuticals, Inc. (Medimetriks) today announced that they have entered into a licensing agreement granting Medimetriks exclusive development and commercialization rights for OPA-15406 in the U.S. and Puerto Rico. The agreement also provides manufacturing rights. OPA-15406 is a topical, non-steroidal phosphodiesterase IV (PDE-4) inhibitor, a new treatment class for atopic dermatitis.