Cipher requests FDA input on isotretinoin trial

WASHINGTON Cipher Pharmaceuticals has requested a meeting with the Food and Drug Administration’s Division of Dermatology and Dental Products to discuss the agency’s views of a phase III safety study to support a modified version of the acne medication isotretinoin.

The drug, CIP-isotretinoin, provides more consistent absorption compared with existing isotretinoin products on the market. In May 2006, Cipher received an approvable letter from the FDA pertaining to its application for CIP-isotretinoin. Cipher submitted its response in October 2006 and received a second approvable letter in April 2007.

In June 2007, Cipher appealed the FDA’s approvable letter for CIP-isotretinoin, which is sold by Roche under the brand name Accutane. The company has met twice since then with the FDA as part of the first stage of the formal dispute resolution process.

In its most recent response to Cipher, an FDA representative agreed with DDDP’s original view that an additional clinical safety study is needed. The company’s request for a meeting with the division means the dispute-resolution process has been put on hold. Larry Andrews, Cipher president and chief executive officer, said the company expects to meet with the FDA in late January.