Maxim withdraws claims on Ceplene

Maxim Pharmaceuticals has agreed to stop promoting its lead drug Ceplene(histamine dihydrochloride; formerly Maxamine) as safe and effective after the US Food and Drug Administration charged the company with improperly touting an unapproved therapy.

Earlier this year, the FDA rejected Maxim's New Drug Application for Ceplene as an adjuvant to interleukin-2 for the treatment of patients with advanced metastatic melanoma. The FDA noted that the Phase III clinical trials forming the basis of Maxim's NDA would not be adequate as a single study to support approval (Marketletter January 29).

The FDA has now posted a letter on its website stating that Maxim is "in violation of the Federal Food, Drug and Cosmetic Act and its implementing regulations," and also noted that many claims made about Ceplene were "based solely upon preliminary and inconclusive data." However, in light of Maxim's commitment to stop promoting its product in this way, the agency now considers the matter closed. Maxim has said that it will continue to study the product's potential as a skin cancer therapy.